Erythropoietin or darbepoetin for patients with cancer

Thomy Tonia; Annette Mettler; Nadège Robert; Guido Schwarzer; Jerome Seidenfeld; Olaf Weingart; Chris Hyde; Andreas Engert; Julia Bohlius

doi:10.1002/14651858.CD003407.pub5

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study. If for a given study more than one reference was included we reported our judgement only for the main reference and left the other references of the same study empty.

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Analysis 1.1

Comparison 1 Haematologic response, Outcome 1 Haematological response ‐ overall.

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Analysis 1.2

Comparison 1 Haematologic response, Outcome 2 Haematologic response ‐ baseline Hb.

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Analysis 1.3

Comparison 1 Haematologic response, Outcome 3 Haematologic response ‐ different malignancies.

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Analysis 1.4

Comparison 1 Haematologic response, Outcome 4 Haematological response‐ age.

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Analysis 1.5

Comparison 1 Haematologic response, Outcome 5 Haematological response‐ age differentiated.

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Analysis 1.6

Comparison 1 Haematologic response, Outcome 6 Haematologic response ‐ different therapies.

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Analysis 1.7

Comparison 1 Haematologic response, Outcome 7 Haematologic response ‐ different therapies differentiated.

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Analysis 1.8

Comparison 1 Haematologic response, Outcome 8 Haematologic response ‐ epoetin versus darbepoetin.

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Analysis 1.9

Comparison 1 Haematologic response, Outcome 9 Haematologic response ‐ duration of ESA medication.

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Analysis 1.10

Comparison 1 Haematologic response, Outcome 10 Haematologic response ‐ iron supplementation.

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Analysis 1.11

Comparison 1 Haematologic response, Outcome 11 Haematologic response ‐ allocation concealment.

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Analysis 1.12

Comparison 1 Haematologic response, Outcome 12 Haematologic response ‐ masking.

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Analysis 1.13

Comparison 1 Haematologic response, Outcome 13 Haematologic response ‐ intention‐to treat.

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Analysis 1.14

Comparison 1 Haematologic response, Outcome 14 Haematologic response ‐ publication.

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Analysis 1.15

Comparison 1 Haematologic response, Outcome 15 Haematological response ‐ merged experimental arms.

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Analysis 2.1

Comparison 2 Change of haemoglobin level, Outcome 1 Change in Hb values ‐ overall.

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Analysis 2.2

Comparison 2 Change of haemoglobin level, Outcome 2 Change in Hb values ‐ baseline Hb.

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Analysis 2.3

Comparison 2 Change of haemoglobin level, Outcome 3 Change in Hb values ‐ different malignancies.

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Analysis 2.4

Comparison 2 Change of haemoglobin level, Outcome 4 Change in Hb values ‐ age.

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Analysis 2.5

Comparison 2 Change of haemoglobin level, Outcome 5 Change in Hb values ‐ age differentiated.

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Analysis 2.6

Comparison 2 Change of haemoglobin level, Outcome 6 Change in Hb values ‐ different therapies.

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Analysis 2.7

Comparison 2 Change of haemoglobin level, Outcome 7 Change in Hb values ‐ different therapies differentiated.

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Analysis 2.8

Comparison 2 Change of haemoglobin level, Outcome 8 Change in Hb values ‐ epoetin vs darbepoetin.

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Analysis 2.9

Comparison 2 Change of haemoglobin level, Outcome 9 Change in Hb values ‐ duration of ESA medication.

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Analysis 2.10

Comparison 2 Change of haemoglobin level, Outcome 10 Change in Hb values ‐ iron supplementation.

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Analysis 2.11

Comparison 2 Change of haemoglobin level, Outcome 11 Change in Hb values ‐ allocation concealment.

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Analysis 2.12

Comparison 2 Change of haemoglobin level, Outcome 12 Change in Hb values ‐ masking.

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Analysis 2.13

Comparison 2 Change of haemoglobin level, Outcome 13 Change in Hb values ‐ intention‐to‐treat.

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Analysis 2.14

Comparison 2 Change of haemoglobin level, Outcome 14 Change in Hb values ‐ publication.

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Analysis 2.15

Comparison 2 Change of haemoglobin level, Outcome 15 Change in Hb values ‐ experimental arms merged.

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Analysis 2.16

Comparison 2 Change of haemoglobin level, Outcome 16 Change in Hb values‐ sensitivity analysis.

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Analysis 2.17

Comparison 2 Change of haemoglobin level, Outcome 17 Change in Hb values ‐ publication sensitivity analysis excluding Henke 2003.

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Analysis 3.1

Comparison 3 Participants receiving red blood cell transfusions, Outcome 1 Participants receiving red blood cell transfusions ‐ overall.

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Analysis 3.2

Comparison 3 Participants receiving red blood cell transfusions, Outcome 2 Participants receiving red blood cell transfusions ‐ baseline Hb.

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Analysis 3.3

Comparison 3 Participants receiving red blood cell transfusions, Outcome 3 Participants receiving red blood cell transfusions ‐ different malignancies.

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Analysis 3.4

Comparison 3 Participants receiving red blood cell transfusions, Outcome 4 Participants receiving red blood cell transfusions ‐ age.

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Analysis 3.5

Comparison 3 Participants receiving red blood cell transfusions, Outcome 5 Participants receiving red blood cell transfusions ‐ age differentiated.

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Analysis 3.6

Comparison 3 Participants receiving red blood cell transfusions, Outcome 6 Participants receiving red blood cell transfusions ‐ different therapies.

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Analysis 3.7

Comparison 3 Participants receiving red blood cell transfusions, Outcome 7 Participants receiving red blood cell transfusions ‐ different therapies differentiated.

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Analysis 3.8

Comparison 3 Participants receiving red blood cell transfusions, Outcome 8 Participants receiving red blood cell transfusions ‐ epoetin versus darbepoetin.

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Analysis 3.9

Comparison 3 Participants receiving red blood cell transfusions, Outcome 9 Participants receiving red blood cell transfusions ‐ duration of ESA medication.

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Analysis 3.10

Comparison 3 Participants receiving red blood cell transfusions, Outcome 10 Participants receiving red blood cell transfusions ‐ iron supplementation.

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Analysis 3.11

Comparison 3 Participants receiving red blood cell transfusions, Outcome 11 Participants receiving red blood cell transfusions ‐ allocation concealment.

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Analysis 3.12

Comparison 3 Participants receiving red blood cell transfusions, Outcome 12 Participants receiving red blood cell transfusions ‐ masking.

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Analysis 3.13

Comparison 3 Participants receiving red blood cell transfusions, Outcome 13 Participants receiving red blood cell transfusions ‐ intention‐to treat.

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Analysis 3.14

Comparison 3 Participants receiving red blood cell transfusions, Outcome 14 Participants receiving red blood cell transfusions ‐ publication.

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Analysis 3.15

Comparison 3 Participants receiving red blood cell transfusions, Outcome 15 Participants receiving red blood cell transfusions ‐ first 4 weeks are....

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Analysis 3.16

Comparison 3 Participants receiving red blood cell transfusions, Outcome 16 Participants receiving red blood cell transfusions ‐ experimental arms merged.

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Analysis 4.1

Comparison 4 Number of red blood cell units transfused per patient, Outcome 1 Number of RBC units transfused ‐ overall.

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Analysis 4.2

Comparison 4 Number of red blood cell units transfused per patient, Outcome 2 Number of RBC units transfused ‐ baseline Hb.

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Analysis 4.3

Comparison 4 Number of red blood cell units transfused per patient, Outcome 3 Number of RBC units transfused ‐ age differentiated.

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Analysis 4.4

Comparison 4 Number of red blood cell units transfused per patient, Outcome 4 Number of RBC units transfused ‐ age.

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Analysis 4.5

Comparison 4 Number of red blood cell units transfused per patient, Outcome 5 Number of RBC units transfused ‐ different malignancies.

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Analysis 4.6

Comparison 4 Number of red blood cell units transfused per patient, Outcome 6 Number of RBC units transfused ‐ different therapies.

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Analysis 4.7

Comparison 4 Number of red blood cell units transfused per patient, Outcome 7 Number of RBC units transfused ‐ different therapies differentiated.

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Analysis 4.8

Comparison 4 Number of red blood cell units transfused per patient, Outcome 8 Number of RBC units transfused ‐ epoetin versus darbepoetin.

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Analysis 4.9

Comparison 4 Number of red blood cell units transfused per patient, Outcome 9 Number of RBC units transfused ‐ duration of ESA medication.

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Analysis 4.10

Comparison 4 Number of red blood cell units transfused per patient, Outcome 10 Number of RBC units transfused ‐ iron supplementation.

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Analysis 4.11

Comparison 4 Number of red blood cell units transfused per patient, Outcome 11 Number of RBC units transfused ‐ allocation concealment.

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Analysis 4.12

Comparison 4 Number of red blood cell units transfused per patient, Outcome 12 Number of RBC units transfused ‐ masking.

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Analysis 4.13

Comparison 4 Number of red blood cell units transfused per patient, Outcome 13 Number of RBC units transfused ‐ intention‐to‐treat.

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Analysis 4.14

Comparison 4 Number of red blood cell units transfused per patient, Outcome 14 Number of RBC units transfused ‐ publication.

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Analysis 4.15

Comparison 4 Number of red blood cell units transfused per patient, Outcome 15 Number of RBC units transfused ‐ first 4 weeks are....

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Analysis 4.16

Comparison 4 Number of red blood cell units transfused per patient, Outcome 16 Number of RBC units transfused ‐ experimental arms merged.

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Analysis 4.17

Comparison 4 Number of red blood cell units transfused per patient, Outcome 17 Number of RBC units transfused ‐ age differentiated sensitivity analysis.

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Analysis 5.1

Comparison 5 Overall survival, Outcome 1 Overall survival ‐ overall.

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Analysis 5.2

Comparison 5 Overall survival, Outcome 2 Overall survival updated review (adjusted results).

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Analysis 5.3

Comparison 5 Overall survival, Outcome 3 Overall survival ‐ baseline Hb.

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Analysis 5.4

Comparison 5 Overall survival, Outcome 4 Overall survival ‐ different malignancies.

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Analysis 5.5

Comparison 5 Overall survival, Outcome 5 Overall survival ‐ age.

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Analysis 5.6

Comparison 5 Overall survival, Outcome 6 Overall survival ‐ age differentiated.

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Analysis 5.7

Comparison 5 Overall survival, Outcome 7 Overall survival ‐ different therapies.

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Analysis 5.8

Comparison 5 Overall survival, Outcome 8 Overall survival ‐ different therapies differentiated.

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Analysis 5.9

Comparison 5 Overall survival, Outcome 9 Overall survival ‐ epoetin vs darbepoetin.

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Analysis 5.10

Comparison 5 Overall survival, Outcome 10 Overall survival ‐ duration of ESA medication.

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Analysis 5.11

Comparison 5 Overall survival, Outcome 11 Overall survival ‐ iron supplementation.

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Analysis 5.12

Comparison 5 Overall survival, Outcome 12 Overall survival ‐ publication.

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Analysis 5.13

Comparison 5 Overall survival, Outcome 13 Overall survival ‐ time‐to‐event or binary mortality data.

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Analysis 5.14

Comparison 5 Overall survival, Outcome 14 Overall survival ‐ allocation concealment.

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Analysis 5.15

Comparison 5 Overall survival, Outcome 15 Overall survival ‐ masking.

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Analysis 5.16

Comparison 5 Overall survival, Outcome 16 Overall survival ‐ intention‐to‐treat.

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Analysis 5.17

Comparison 5 Overall survival, Outcome 17 Overall survival ‐ follow up.

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Analysis 5.18

Comparison 5 Overall survival, Outcome 18 Overall survival ‐ follow up and design.

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Analysis 5.19

Comparison 5 Overall survival, Outcome 19 Overall survival‐ experimental arms merged.

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Analysis 5.20

Comparison 5 Overall survival, Outcome 20 Overall survival‐ experimental arms merged sens pos.

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Analysis 5.21

Comparison 5 Overall survival, Outcome 21 Overall survival‐ experimental arms merged sens neg.

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Analysis 5.22

Comparison 5 Overall survival, Outcome 22 Overall survival ‐ sensitivity analysis baseline Hb.

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Analysis 5.23

Comparison 5 Overall survival, Outcome 23 Overall survival ‐ sensitivity analysis iron supplementation.

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Analysis 5.24

Comparison 5 Overall survival, Outcome 24 Overall survival ‐ sensitivity analysis intention‐to‐treat.

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Analysis 6.1

Comparison 6 On‐study mortality, Outcome 1 On‐study mortality ‐ overall.

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Analysis 6.2

Comparison 6 On‐study mortality, Outcome 2 On‐study mortality ‐ baseline Hb.

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Analysis 6.3

Comparison 6 On‐study mortality, Outcome 3 On‐study mortality ‐ different malignancies.

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Analysis 6.4

Comparison 6 On‐study mortality, Outcome 4 On‐study mortality ‐ age.

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Analysis 6.5

Comparison 6 On‐study mortality, Outcome 5 On‐study mortality ‐ age differentiated.

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Analysis 6.6

Comparison 6 On‐study mortality, Outcome 6 On‐study mortality ‐ different therapies.

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Analysis 6.7

Comparison 6 On‐study mortality, Outcome 7 On‐study mortality ‐ different therapies differentiated.

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Analysis 6.8

Comparison 6 On‐study mortality, Outcome 8 On‐study mortality ‐ duration of ESA medication.

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Analysis 6.9

Comparison 6 On‐study mortality, Outcome 9 On‐study mortality ‐ epoetin vs darbepoetin.

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Analysis 6.10

Comparison 6 On‐study mortality, Outcome 10 On‐study mortality ‐ iron supplementation.

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Analysis 6.11

Comparison 6 On‐study mortality, Outcome 11 On‐study mortality ‐ publication.

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Analysis 6.12

Comparison 6 On‐study mortality, Outcome 12 On‐study mortality ‐ time‐to‐event or binary mortality data.

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Analysis 6.13

Comparison 6 On‐study mortality, Outcome 13 On‐study mortality ‐ allocation concealment.

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Analysis 6.14

Comparison 6 On‐study mortality, Outcome 14 On‐study mortality ‐ masking.

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Analysis 6.15

Comparison 6 On‐study mortality, Outcome 15 On‐study mortality ‐ intention‐to‐treat.

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Analysis 6.16

Comparison 6 On‐study mortality, Outcome 16 On‐study mortality ‐ sensitivity analysis ‐ follow‐up.

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Analysis 6.17

Comparison 6 On‐study mortality, Outcome 17 On‐study mortality ‐ sensitivity analysis experimental arms merged.

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Analysis 6.18

Comparison 6 On‐study mortality, Outcome 18 On‐study mortality ‐ sensitivity analysis intention‐to‐treat.

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Analysis 6.19

Comparison 6 On‐study mortality, Outcome 19 On‐study mortality ‐ sensitivity analysis excluding Leyland and Smith.

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Analysis 7.1

Comparison 7 Complete tumour response, Outcome 1 Complete tumour response.

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Analysis 7.2

Comparison 7 Complete tumour response, Outcome 2 Tumour‐response specific quality criteria.

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Analysis 7.3

Comparison 7 Complete tumour response, Outcome 3 Complete tumour response ‐ experimental study arms merged.

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Analysis 8.1

Comparison 8 Change in FACT‐Fatigue 13, Outcome 1 Change in FACT‐Fatigue (13 items) ‐ overall.

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Analysis 8.2

Comparison 8 Change in FACT‐Fatigue 13, Outcome 2 Change in FACT‐Fatigue sensitivity analysis‐ Tsuboi.

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Analysis 8.3

Comparison 8 Change in FACT‐Fatigue 13, Outcome 3 Change in FACT‐F 13 ‐ baseline Hb.

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Analysis 8.4

Comparison 8 Change in FACT‐Fatigue 13, Outcome 4 Change in FACT‐F 13 ‐ different malignancies.

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Analysis 8.5

Comparison 8 Change in FACT‐Fatigue 13, Outcome 5 Change in FACT‐F 13 ‐ age.

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Analysis 8.6

Comparison 8 Change in FACT‐Fatigue 13, Outcome 6 Change in FACT‐F 13 ‐ different therapies.

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Analysis 8.7

Comparison 8 Change in FACT‐Fatigue 13, Outcome 7 Change in FACT‐F 13 ‐ different therapies differentiated.

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Analysis 8.8

Comparison 8 Change in FACT‐Fatigue 13, Outcome 8 Change in FACT‐F 13 ‐ epoetin versus darbepoetin.

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Analysis 8.9

Comparison 8 Change in FACT‐Fatigue 13, Outcome 9 Change in FACT‐F 13 ‐ duration of ESA medication.

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Analysis 8.10

Comparison 8 Change in FACT‐Fatigue 13, Outcome 10 Change in FACT‐F 13 ‐ iron supplementation.

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Analysis 8.11

Comparison 8 Change in FACT‐Fatigue 13, Outcome 11 Change in FACT‐F 13 ‐ allocation concealment.

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Analysis 8.12

Comparison 8 Change in FACT‐Fatigue 13, Outcome 12 Change in FACT‐F 13 ‐ masking.

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Analysis 8.13

Comparison 8 Change in FACT‐Fatigue 13, Outcome 13 Change in FACT‐F 13 ‐ intention‐to treat.

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Analysis 8.14

Comparison 8 Change in FACT‐Fatigue 13, Outcome 14 Change in FACT‐F 13 ‐ publication.

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Analysis 8.15

Comparison 8 Change in FACT‐Fatigue 13, Outcome 15 Change in FACT‐F 13 ‐ type of data.

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Analysis 9.1

Comparison 9 Change in FACT‐An 20, Outcome 1 Change in FACT‐An (20 items) ‐ overall.

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Analysis 9.2

Comparison 9 Change in FACT‐An 20, Outcome 2 Change in FACT‐An 20 ‐ baseline Hb.

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Analysis 9.3

Comparison 9 Change in FACT‐An 20, Outcome 3 Change in FACT‐An 20 ‐ different malignancies.

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Analysis 9.4

Comparison 9 Change in FACT‐An 20, Outcome 4 Change in FACT‐An 20 ‐ age.

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Analysis 9.5

Comparison 9 Change in FACT‐An 20, Outcome 5 Change in FACT‐An 20 ‐ different therapies.

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Analysis 9.6

Comparison 9 Change in FACT‐An 20, Outcome 6 Change in FACT‐An 20 ‐ different therapies differentiated.

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Analysis 9.7

Comparison 9 Change in FACT‐An 20, Outcome 7 Change in FACT‐An 20 ‐ epoetin versus darbepoetin.

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Analysis 9.8

Comparison 9 Change in FACT‐An 20, Outcome 8 Change in FACT‐An 20 ‐ duration of ESA medication.

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Analysis 9.9

Comparison 9 Change in FACT‐An 20, Outcome 9 Change in FACT‐An 20 ‐ iron supplementation.

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Analysis 9.10

Comparison 9 Change in FACT‐An 20, Outcome 10 Change in FACT‐An 20 ‐ allocation concealment.

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Analysis 9.11

Comparison 9 Change in FACT‐An 20, Outcome 11 Change in FACT‐An 20 ‐ masking.

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Analysis 9.12

Comparison 9 Change in FACT‐An 20, Outcome 12 Change in FACT‐An 20 ‐ intention‐to treat.

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Analysis 9.13

Comparison 9 Change in FACT‐An 20, Outcome 13 Change in FACT‐An 20 ‐ publication.

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Analysis 9.14

Comparison 9 Change in FACT‐An 20, Outcome 14 Change in FACT‐An 20 ‐ data type.

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Analysis 10.1

Comparison 10 Change in FACT‐An Total 47, Outcome 1 Change in FACT‐An Total (47 items) ‐ overall.

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Analysis 10.2

Comparison 10 Change in FACT‐An Total 47, Outcome 2 Change in FACT‐An Total 47‐ sensitivity analysis.

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Analysis 10.3

Comparison 10 Change in FACT‐An Total 47, Outcome 3 Change in FACT‐An Total 47 ‐ baseline Hb.

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Analysis 10.4

Comparison 10 Change in FACT‐An Total 47, Outcome 4 Change in FACT‐An Total 47 ‐ different malignancies.

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Analysis 10.5

Comparison 10 Change in FACT‐An Total 47, Outcome 5 Change in FACT‐An Total 47 ‐ age.

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Analysis 10.6

Comparison 10 Change in FACT‐An Total 47, Outcome 6 Change in FACT‐An Total 47 ‐ different therapies.

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Analysis 10.7

Comparison 10 Change in FACT‐An Total 47, Outcome 7 Change in FACT‐An Total 47 ‐ different therapies differentiated.

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Analysis 10.8

Comparison 10 Change in FACT‐An Total 47, Outcome 8 Change in FACT‐An Total 47 ‐ epoetin versus darbepoetin.

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Analysis 10.9

Comparison 10 Change in FACT‐An Total 47, Outcome 9 Change in FACT‐An Total 47 ‐ duration of ESA medication.

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Analysis 10.10

Comparison 10 Change in FACT‐An Total 47, Outcome 10 Change in FACT‐An Total 47 ‐ iron supplementation.

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Analysis 10.11

Comparison 10 Change in FACT‐An Total 47, Outcome 11 Change in FACT‐An Total 47 ‐ allocation concealment.

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Analysis 10.12

Comparison 10 Change in FACT‐An Total 47, Outcome 12 Change in FACT‐An Total 47 ‐ masking.

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Analysis 10.13

Comparison 10 Change in FACT‐An Total 47, Outcome 13 Change in FACT‐An Total 47 ‐ intention‐to treat.

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Analysis 10.14

Comparison 10 Change in FACT‐An Total 47, Outcome 14 Change in FACT‐An Total 47 ‐ publication.

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Analysis 10.15

Comparison 10 Change in FACT‐An Total 47, Outcome 15 Change in Fact‐An Total 47 ‐ data type.

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Analysis 10.16

Comparison 10 Change in FACT‐An Total 47, Outcome 16 FACT‐An Total 47 ‐ merged experimental study arms.

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Analysis 11.1

Comparison 11 Thrombotic events, Outcome 1 Thrombotic events ‐ overall.

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Analysis 11.2

Comparison 11 Thrombotic events, Outcome 2 Thrombotic events ‐ baseline Hb.

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Analysis 11.3

Comparison 11 Thrombotic events, Outcome 3 Thrombotic events ‐ different malignancies.

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Analysis 11.4

Comparison 11 Thrombotic events, Outcome 4 Thrombotic events ‐ age.

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Analysis 11.5

Comparison 11 Thrombotic events, Outcome 5 Thrombotic events ‐ age differentiated.

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Analysis 11.6

Comparison 11 Thrombotic events, Outcome 6 Thrombotic events ‐ different therapies.

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Analysis 11.7

Comparison 11 Thrombotic events, Outcome 7 Thrombotic events ‐ different therapies differentiated.

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Analysis 11.8

Comparison 11 Thrombotic events, Outcome 8 Thrombotic events ‐ epoetin versus darbepoetin.

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Analysis 11.9

Comparison 11 Thrombotic events, Outcome 9 Thrombotic events ‐ duration of ESA treatment.

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Analysis 11.10

Comparison 11 Thrombotic events, Outcome 10 Thrombotic events ‐ iron supplementation.

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Analysis 11.11

Comparison 11 Thrombotic events, Outcome 11 Thrombotic events ‐ concealment of allocation.

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Analysis 11.12

Comparison 11 Thrombotic events, Outcome 12 Thrombotic events ‐ masking.

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Analysis 11.13

Comparison 11 Thrombotic events, Outcome 13 Thrombotic events ‐ intention‐to‐treat.

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Analysis 11.14

Comparison 11 Thrombotic events, Outcome 14 Thrombotic events ‐ publication.

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Analysis 11.15

Comparison 11 Thrombotic events, Outcome 15 Thrombotic events ‐ experimental arms merged.

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Analysis 12.1

Comparison 12 Hypertension, Outcome 1 Hypertension ‐ overall.

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Analysis 12.2

Comparison 12 Hypertension, Outcome 2 Hypertension ‐ merged experimental study arms.

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Analysis 12.3

Comparison 12 Hypertension, Outcome 3 Hypertension ‐ sensitivity analysis Dammacco.

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Analysis 12.4

Comparison 12 Hypertension, Outcome 4 Hypertension ‐ sensitivity analysis random effects.

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Analysis 12.5

Comparison 12 Hypertension, Outcome 5 Hypertension ‐ sensitivity analysis without Rose.

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Analysis 13.1

Comparison 13 Thrombocytopenia or haemorrhage, Outcome 1 Thrombocytopenia ‐ overall.

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Analysis 13.2

Comparison 13 Thrombocytopenia or haemorrhage, Outcome 2 Thrombocytopenia ‐ merged experimental arms.

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Analysis 13.3

Comparison 13 Thrombocytopenia or haemorrhage, Outcome 3 Thrombocytopenia ‐ sensitivity analysis random effects.

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Analysis 14.1

Comparison 14 Rash, Outcome 1 Rash ‐ overall.

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Analysis 14.2

Comparison 14 Rash, Outcome 2 Rash ‐ merged experimental arms.

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Analysis 15.1

Comparison 15 Seizure, Outcome 1 Seizure ‐ overall.

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Summary of findings for the main comparison. Erythropoietin or Darbepoetin for patients with cancer

Erythropoietin or Darbepoetin for patients with cancer
Patient or population: patients with cancer Settings: Intervention: Erythropoietin or Darbepoetin
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Erythropoietin or Darbepoetin
Overall survival	Low		HR 1.05 (1 to 1.11)	19003 (78 studies)	⊕⊕⊕⊕ high
	50 per 1000	52 per 1000 (50 to 55)
	Moderate
	142 per 1000	149 per 1000 (142 to 156)
	High
	250 per 1000	261 per 1000 (250 to 273)
On‐study mortality Death occurring up to 30 days after active study protocol	Low		HR 1.17 (1.06 to 1.29)	15935 (70 studies)	⊕⊕⊕⊕ high
	10 per 1000	12 per 1000 (11 to 13)
	Moderate
	59 per 1000	69 per 1000 (62 to 75)
	High
	98 per 1000	114 per 1000 (104 to 125)
Thrombotic events	Low		RR 1.52 (1.33 to 1.73)	15278 (57 studies)	⊕⊕⊕⊝ moderate¹
	20 per 1000	30 per 1000 (27 to 35)
	Moderate
	46 per 1000	70 per 1000 (61 to 80)
	High
	100 per 1000	152 per 1000 (133 to 173)
Quality of Life ‐ Change in FACT‐Fatigue (13 items) FACT‐F 13 sub‐scale		The mean quality of life ‐ change in fact‐fatigue (13 items) in the intervention groups was 2.08 higher (1.43 to 2.72 higher)		4965 (18 studies)	⊕⊕⊝⊝ low^2,3
Quality of Life ‐ Change in FACT‐Anaemia (20 items) FACT‐An 20		The mean quality of life ‐ change in fact‐an (20 items) in the intervention groups was 6.14 higher (4.55 to 7.73 higher)		1085 (6 studies)	⊕⊕⊝⊝ low^4,5
Participants receiving red blood cell transfusions	Low		RR 0.65 (0.62 to 0.68)	15877 (70 studies)	⊕⊕⊕⊝ moderate⁶
	300 per 1000	195 per 1000 (186 to 204)
	Moderate
	389 per 1000	253 per 1000 (241 to 265)
	High
	700 per 1000	455 per 1000 (434 to 476)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; HR: Hazard ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ A funnel plot analysis revealed a significant asymmetry, suggesting that negative results (in this case no thrombotic event) have been underreported ² Only 18 out of a total of 91 studies assessing FACT‐13 reported this endpoint, which suggests some reporting bias, even if the funnel plot did not show an asymmetry. 13 more studies (i.e. studies that stated they either used FACT‐F or that they used FACT‐An 47 but do not report separately for FACT‐F or report it in a way that we cannot use. ³ Overall, it seems that there is an effect to fatigue‐related symptoms for patients treated with ESAs compared to controls; this effect, however, did not reach the threshold for a clinically important difference defined as 3.0. ⁴ Only 6 out of a total of 91 studies assessing FACT‐20 reported this endpoint, which suggests some reporting bias, even if the funnel plot did not show an asymmetry. Data from 19 studies addressing QoL can not used for review in cause of missing data (i.e.16 studies that stated they either used fact‐an or that they used fact‐an 47 but do not report separately for fact‐an). Out of these 4 studies which refer to “FACT‐An”/ to “fatigue sub‐scale”, were not useable because we cannot safely say to which instrument they are refer to. ⁵ Overall, the effects of ESAs to fatigue and anaemia related symptoms seem to be beneficial and the difference between groups reaches both statistical and clinical significance (clinically important difference defined as 4‐5). ⁶ A funnel plot analysis showed significant asymmetry between the studies, suggesting that negative results were under reported.

Summary of findings for the main comparison. Erythropoietin or Darbepoetin for patients with cancer

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Table 1. Haematologic response: results of meta‐regression analysis

Variable	log (effect size)	standard error	P value
Intercept	0.81	0.1189	<0.0001
Hb baseline 10‐12 g/dL	0.62	0.1430	<0.0001
Hb baseline > 12 g/dL	0.85	0.4694	0.0688
Children	‐0.68	0.1653	<0.0001
Iron given differently in both study arms	‐0.64	0.2348	0.0068
Iron supplementation as necessary	0.35	0.1315	0.0081
Hb: haemoglobin

Table 1. Haematologic response: results of meta‐regression analysis

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Table 2. Hb change: results of meta‐regression analysis

Variable	mean difference	standard error	P value
Intercept	1.15	0.1792	<0.0001
Children	‐1.41	0.6911	0.0414
Short acting ESA	0.56	0.2041	0.0060
ESA: erythropoiesis stimulating agent

Table 2. Hb change: results of meta‐regression analysis

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Table 3. Participants receiving RBC transfusions: results of meta‐regression analysis

Variable	log(effect size)	Standard error	P value
Intercept	‐0.22	0.0506	<0.0001
Hb 10 ‐ 12 g/dL	‐0.15	0.0650	0.0254
Hb > 12 g/dL	0.07	0.0601	0.2774
MDS	0.01	0.1004	0.8967
Solid and haematological tumours	‐0.03	0.0648	0.6726
Solid tumours	‐0.39	0.0637	<0.0001
MDS: myelodysplastic syndrome RBC: red blood cell

Table 3. Participants receiving RBC transfusions: results of meta‐regression analysis

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Table 4. FACT‐F 13: results of meta‐regression analysis

Variable	mean difference	standard error	P value
Intercept	1.09	0.6158	0.0779
Short acting ESA	2.20	0.8346	0.0083
ESA: erythropoiesis stimulating agent

Table 4. FACT‐F 13: results of meta‐regression analysis

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Table 5. FACT‐An 47: results of meta‐regression analysis

Variable	mean difference	Standard error	P value
Intercept	6.10	2.3783	0.0103
Chemotherapy, < 70% of participants receiving platinum‐based chemotherapy	‐5.82	3.1929	0.0683
Chemotherapy, > 70% of participants receiving platinum‐based chemotherapy	0.81	3.7926	0.8303
No anticancer therapy	23.80	4.0571	<0.0001
Radiotherapy	‐4.20	3.9147	0.2836

Table 5. FACT‐An 47: results of meta‐regression analysis

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Comparison 1. Haematologic response

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Haematological response ‐ overall Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

2 Haematologic response ‐ baseline Hb Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

2.1 Hb <= 10 g/dL	36	4137	Risk Ratio (M‐H, Fixed, 95% CI)	3.02 [2.72, 3.35]
2.2 Hb 10 to 12 g/dL	8	1775	Risk Ratio (M‐H, Fixed, 95% CI)	4.60 [3.79, 5.58]
2.3 Hb > 12 g/dL	1	380	Risk Ratio (M‐H, Fixed, 95% CI)	7.48 [3.00, 18.62]
2.4 Hb category unclear	1	121	Risk Ratio (M‐H, Fixed, 95% CI)	2.04 [1.20, 3.46]
3 Haematologic response ‐ different malignancies Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

3.1 solid tumours	18	3089	Risk Ratio (M‐H, Fixed, 95% CI)	3.56 [3.12, 4.07]
3.2 haematological malignancies	15	1623	Risk Ratio (M‐H, Fixed, 95% CI)	3.12 [2.64, 3.69]
3.3 MDS	2	151	Risk Ratio (M‐H, Fixed, 95% CI)	4.27 [0.86, 21.19]
3.4 mixed	12	1550	Risk Ratio (M‐H, Fixed, 95% CI)	3.38 [2.80, 4.08]
3.5 not reported	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Haematological response‐ age Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

4.1 children	1	222	Risk Ratio (M‐H, Fixed, 95% CI)	1.62 [1.20, 2.18]
4.2 adults	45	6191	Risk Ratio (M‐H, Fixed, 95% CI)	3.55 [3.23, 3.90]
5 Haematological response‐ age differentiated Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

5.1 only children <18 years	1	222	Risk Ratio (M‐H, Fixed, 95% CI)	1.62 [1.20, 2.18]
5.2 adults ≥18 years	43	5623	Risk Ratio (M‐H, Fixed, 95% CI)	3.34 [3.03, 3.68]
5.3 >70% non‐elderly 18‐65 years	2	568	Risk Ratio (M‐H, Fixed, 95% CI)	8.26 [5.22, 13.06]
5.4 only non‐elderly adults	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.5 >70% elderly >65 years	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.6 only elderly adults	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Haematologic response ‐ different therapies Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

6.1 chemotherapy	38	5562	Risk Ratio (M‐H, Fixed, 95% CI)	3.32 [3.02, 3.64]
6.2 radiotherapy/radiochemotherapy	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 no therapy	7	630	Risk Ratio (M‐H, Fixed, 95% CI)	5.50 [3.25, 9.31]
6.4 other	1	221	Risk Ratio (M‐H, Fixed, 95% CI)	2.87 [1.69, 4.85]
7 Haematologic response ‐ different therapies differentiated Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

7.1 chemotherapy, >70% with platinum	7	1301	Risk Ratio (M‐H, Fixed, 95% CI)	3.12 [2.51, 3.87]
7.2 chemotherapy, <70% platinum containing	3	659	Risk Ratio (M‐H, Fixed, 95% CI)	2.71 [2.16, 3.40]
7.3 chemotherapy without platinum (all patients)	17	2614	Risk Ratio (M‐H, Fixed, 95% CI)	3.73 [3.26, 4.26]
7.4 chemotherapy, platinum and non‐platinum containing, no numbers given	8	643	Risk Ratio (M‐H, Fixed, 95% CI)	4.05 [2.84, 5.77]
7.5 chemotherapy no details given	3	345	Risk Ratio (M‐H, Fixed, 95% CI)	2.13 [1.59, 2.86]
7.6 radiochemotherapy	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.7 radiotherapy	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.8 no therapy	7	630	Risk Ratio (M‐H, Fixed, 95% CI)	5.50 [3.25, 9.31]
7.9 other	1	221	Risk Ratio (M‐H, Fixed, 95% CI)	2.87 [1.69, 4.85]
8 Haematologic response ‐ epoetin versus darbepoetin Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

8.1 Epoetin	30	5270	Risk Ratio (M‐H, Fixed, 95% CI)	3.27 [2.97, 3.59]
8.2 Darbepoetin	16	1143	Risk Ratio (M‐H, Fixed, 95% CI)	4.22 [3.22, 5.55]
9 Haematologic response ‐ duration of ESA medication Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

9.1 6 to 9 weeks	6	349	Risk Ratio (M‐H, Fixed, 95% CI)	3.74 [1.94, 7.19]
9.2 12 to 16 weeks	34	4574	Risk Ratio (M‐H, Fixed, 95% CI)	3.17 [2.87, 3.51]
9.3 more than 17 weeks	6	1490	Risk Ratio (M‐H, Fixed, 95% CI)	4.41 [3.52, 5.52]
10 Haematologic response ‐ iron supplementation Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

10.1 fixed iron supplementation	2	441	Risk Ratio (M‐H, Fixed, 95% CI)	2.43 [1.92, 3.07]
10.2 iron supplementation as necessary	36	5265	Risk Ratio (M‐H, Fixed, 95% CI)	3.63 [3.27, 4.03]
10.3 no explicit statement on iron supplementation or no iron given	7	399	Risk Ratio (M‐H, Fixed, 95% CI)	4.82 [2.64, 8.81]
10.4 explicitly stated NO IRON	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.5 iron given differently in both study arms	1	308	Risk Ratio (M‐H, Fixed, 95% CI)	2.22 [1.63, 3.01]
11 Haematologic response ‐ allocation concealment Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

11.1 adequate	30	4721	Risk Ratio (M‐H, Fixed, 95% CI)	3.35 [3.02, 3.72]
11.2 unclear	16	1692	Risk Ratio (M‐H, Fixed, 95% CI)	3.50 [2.92, 4.19]
12 Haematologic response ‐ masking Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

12.1 double‐blind	29	3430	Risk Ratio (M‐H, Fixed, 95% CI)	3.02 [2.70, 3.37]
12.2 unblinded	17	2983	Risk Ratio (M‐H, Fixed, 95% CI)	4.07 [3.49, 4.74]
13 Haematologic response ‐ intention‐to treat Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

13.1 ITT or less than 10% of participants per study arm excluded	41	5657	Risk Ratio (M‐H, Fixed, 95% CI)	3.32 [3.03, 3.65]
13.2 more than 10% of participants per study arm excluded	2	512	Risk Ratio (M‐H, Fixed, 95% CI)	6.85 [3.76, 12.48]
13.3 unclear	3	244	Risk Ratio (M‐H, Fixed, 95% CI)	3.04 [1.92, 4.80]
14 Haematologic response ‐ publication Show forest plot	46	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.39 [3.10, 3.71]

14.1 full text publication	32	5229	Risk Ratio (M‐H, Fixed, 95% CI)	3.44 [3.12, 3.80]
14.2 abstract publication	2	123	Risk Ratio (M‐H, Fixed, 95% CI)	5.19 [2.23, 12.04]
14.3 unpublished data	10	880	Risk Ratio (M‐H, Fixed, 95% CI)	3.44 [2.45, 4.82]
14.4 FDA hearing	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.5 clinical trial result information	2	181	Risk Ratio (M‐H, Fixed, 95% CI)	1.98 [1.36, 2.89]
15 Haematological response ‐ merged experimental arms Show forest plot	31	6413	Risk Ratio (M‐H, Fixed, 95% CI)	3.42 [3.12, 3.74]

Comparison 1. Haematologic response

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Comparison 2. Change of haemoglobin level

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change in Hb values ‐ overall Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

2 Change in Hb values ‐ baseline Hb Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

2.1 Hb <=10g/dL	41	5092	Mean Difference (IV, Fixed, 95% CI)	1.53 [1.43, 1.62]
2.2 Hb 10 to 12 g/dL	23	3572	Mean Difference (IV, Fixed, 95% CI)	1.79 [1.71, 1.88]
2.3 Hb >12 g/dL	10	2824	Mean Difference (IV, Fixed, 95% CI)	1.12 [0.99, 1.25]
2.4 unclear	1	121	Mean Difference (IV, Fixed, 95% CI)	1.53 [0.91, 2.15]
3 Change in Hb values ‐ different malignancies Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

3.1 solid tumours	45	6262	Mean Difference (IV, Fixed, 95% CI)	1.76 [1.68, 1.83]
3.2 haematological malignancies	14	2391	Mean Difference (IV, Fixed, 95% CI)	1.05 [0.90, 1.19]
3.3 MDS	1	28	Mean Difference (IV, Fixed, 95% CI)	1.87 [0.89, 2.85]
3.4 mixed	15	2928	Mean Difference (IV, Fixed, 95% CI)	1.35 [1.21, 1.48]
3.5 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Change in Hb values ‐ age Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

4.1 children	1	222	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐0.27, 0.87]
4.2 adults	74	11387	Mean Difference (IV, Fixed, 95% CI)	1.58 [1.52, 1.64]
5 Change in Hb values ‐ age differentiated Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

5.1 only children <18 years	1	222	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐0.27, 0.87]
5.2 adults ≥18 years	62	8214	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.49, 1.64]
5.3 > 70% non‐elderly 18‐65 years	9	1136	Mean Difference (IV, Fixed, 95% CI)	1.99 [1.88, 2.10]
5.4 only non‐elderly adults	2	1992	Mean Difference (IV, Fixed, 95% CI)	0.76 [0.60, 0.91]
5.5 > 70% elderly >65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.6 only elderly adults	1	45	Mean Difference (IV, Fixed, 95% CI)	2.70 [1.87, 3.53]
6 Change in Hb values ‐ different therapies Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

6.1 chemotherapy	58	8956	Mean Difference (IV, Fixed, 95% CI)	1.46 [1.39, 1.52]
6.2 radiotherapy/radiochemotherapy	8	974	Mean Difference (IV, Fixed, 95% CI)	2.41 [2.24, 2.58]
6.3 no therapy	9	1679	Mean Difference (IV, Fixed, 95% CI)	1.42 [1.25, 1.60]
7 Change in Hb values ‐ different therapies differentiated Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

7.1 chemotherapy, >70% with platinum	19	2126	Mean Difference (IV, Fixed, 95% CI)	1.68 [1.55, 1.82]
7.2 chemotherapy, <70% platinum containing	7	1315	Mean Difference (IV, Fixed, 95% CI)	1.84 [1.62, 2.05]
7.3 chemotherapy without platinum	22	4511	Mean Difference (IV, Fixed, 95% CI)	1.33 [1.25, 1.42]
7.4 chemotherapy, platinum and non‐platinum containing, no numbers given	9	782	Mean Difference (IV, Fixed, 95% CI)	1.37 [1.13, 1.61]
7.5 chemotherapy, no details given	1	222	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐0.27, 0.87]
7.6 radiotherapy	5	696	Mean Difference (IV, Fixed, 95% CI)	2.32 [2.01, 2.63]
7.7 radiochemotherapy	3	278	Mean Difference (IV, Fixed, 95% CI)	2.45 [2.25, 2.65]
7.8 no therapy	9	1679	Mean Difference (IV, Fixed, 95% CI)	1.42 [1.25, 1.60]
8 Change in Hb values ‐ epoetin vs darbepoetin Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

8.1 Epoetin	57	8304	Mean Difference (IV, Fixed, 95% CI)	1.69 [1.62, 1.75]
8.2 Darbepoetin	18	3305	Mean Difference (IV, Fixed, 95% CI)	1.13 [1.00, 1.25]
9 Change in Hb values ‐ duration of ESA medication Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

9.1 6 to 9 weeks	17	1235	Mean Difference (IV, Fixed, 95% CI)	2.30 [2.16, 2.44]
9.2 12 to 16 weeks	43	6393	Mean Difference (IV, Fixed, 95% CI)	1.62 [1.54, 1.70]
9.3 more than 17 weeks	15	3981	Mean Difference (IV, Fixed, 95% CI)	1.05 [0.95, 1.16]
10 Change in Hb values ‐ iron supplementation Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

10.1 fixed iron supplementation	14	2483	Mean Difference (IV, Fixed, 95% CI)	1.94 [1.81, 2.07]
10.2 iron supplementation as necessary	53	8807	Mean Difference (IV, Fixed, 95% CI)	1.47 [1.40, 1.53]
10.3 no explicit statement on iron supplementation or no iron given	8	319	Mean Difference (IV, Fixed, 95% CI)	1.66 [1.34, 1.99]
10.4 explicitly stated no iron new	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.5 iron given differently in both study arms new ongoing	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
11 Change in Hb values ‐ allocation concealment Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

11.1 adequate	45	6768	Mean Difference (IV, Fixed, 95% CI)	1.52 [1.45, 1.60]
11.2 unclear	30	4841	Mean Difference (IV, Fixed, 95% CI)	1.62 [1.53, 1.71]
12 Change in Hb values ‐ masking Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

12.1 double‐blind	42	7438	Mean Difference (IV, Fixed, 95% CI)	1.47 [1.40, 1.55]
12.2 unblinded	33	4171	Mean Difference (IV, Fixed, 95% CI)	1.67 [1.59, 1.75]
13 Change in Hb values ‐ intention‐to‐treat Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

13.1 ITT or less than 10% of participants per study arm excluded	57	9137	Mean Difference (IV, Fixed, 95% CI)	1.61 [1.55, 1.68]
13.2 more than 10% of participants per study arm excluded	18	2472	Mean Difference (IV, Fixed, 95% CI)	1.28 [1.13, 1.43]
13.3 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14 Change in Hb values ‐ publication Show forest plot	75	11609	Mean Difference (IV, Fixed, 95% CI)	1.57 [1.51, 1.62]

14.1 full text publication	59	10026	Mean Difference (IV, Fixed, 95% CI)	1.54 [1.47, 1.60]
14.2 abstract publication	3	252	Mean Difference (IV, Fixed, 95% CI)	1.70 [1.30, 2.09]
14.3 unpublished data	10	804	Mean Difference (IV, Fixed, 95% CI)	1.56 [1.36, 1.76]
14.4 ODAC documents	1	346	Mean Difference (IV, Fixed, 95% CI)	2.5 [2.14, 2.86]
14.5 Clinical trials results	2	181	Mean Difference (IV, Fixed, 95% CI)	1.48 [0.94, 2.02]
15 Change in Hb values ‐ experimental arms merged Show forest plot	56	11609	Mean Difference (IV, Fixed, 95% CI)	1.56 [1.51, 1.62]

16 Change in Hb values‐ sensitivity analysis Show forest plot	65	8685	Mean Difference (IV, Fixed, 95% CI)	1.66 [1.59, 1.72]

17 Change in Hb values ‐ publication sensitivity analysis excluding Henke 2003 Show forest plot	74	11263	Mean Difference (IV, Fixed, 95% CI)	1.54 [1.48, 1.60]

17.1 full text publication	58	8723	Mean Difference (IV, Fixed, 95% CI)	1.63 [1.57, 1.70]
17.2 abstract publication	4	1555	Mean Difference (IV, Fixed, 95% CI)	0.87 [0.69, 1.04]
17.3 unpublished data	10	804	Mean Difference (IV, Fixed, 95% CI)	1.56 [1.36, 1.76]
17.4 ODAC documents	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
17.5 clinical study report	2	181	Mean Difference (IV, Fixed, 95% CI)	1.48 [0.94, 2.02]

Comparison 2. Change of haemoglobin level

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Comparison 3. Participants receiving red blood cell transfusions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants receiving red blood cell transfusions ‐ overall Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

2 Participants receiving red blood cell transfusions ‐ baseline Hb Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

2.1 Hb <=10 g/dL	42	5605	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.67, 0.76]
2.2 Hb 10 to 12 g/dL	29	5669	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.46, 0.55]
2.3 Hb > 12 g/dL	17	4819	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.67, 0.78]
2.4 unclear	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Participants receiving red blood cell transfusions ‐ different malignancies Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

3.1 solid tumours	53	9305	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.46, 0.54]
3.2 haematological malignancies	15	2852	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.75, 0.86]
3.3 MDS	2	151	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.68, 0.96]
3.4 mixed	19	3785	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.68, 0.80]
3.5 not reported	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Participants receiving red blood cell transfusions ‐ age Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

4.1 children	1	222	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.71, 0.99]
4.2 adults	87	15871	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.62, 0.67]
5 Participants receiving red blood cell transfusions ‐ age differentiated Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

5.1 only children <18 years	1	222	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.71, 0.99]
5.2 adults ≥18 years	70	11556	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.59, 0.66]
5.3 >68% non‐elderly 18‐65 years	11	1343	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.41, 0.60]
5.4 only non‐elderly adults	5	2927	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.72, 0.84]
5.5 >68% elderly >65 years	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.6 only elderly adults	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.17, 0.94]
6 Participants receiving red blood cell transfusions ‐ different therapies Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

6.1 chemotherapy	71	13405	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.61, 0.67]
6.2 radio/radiochemotherapy	6	693	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.34, 0.58]
6.3 no therapy	10	1774	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.72, 0.91]
6.4 unclear/other	1	221	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.60, 0.99]
7 Participants receiving red blood cell transfusions ‐ different therapies differentiated Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

7.1 chemotherapy, > 70% with platinum	26	3592	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.44, 0.54]
7.2 chemotherapy, < 70% with platinum	10	2043	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.55, 0.73]
7.3 chemotherapy without platinum (all patients)	23	6509	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.69, 0.78]
7.4 chemotherapy, platinum and non‐platinum containing, no numbers given	9	772	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.43, 0.65]
7.5 chemotherapy no details given	3	489	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.63, 0.86]
7.6 radiochemotherapy	6	693	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.34, 0.58]
7.7 radiotherapy	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.8 no therapy	10	1774	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.72, 0.91]
7.9 unclear/other	1	221	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.60, 0.99]
8 Participants receiving red blood cell transfusions ‐ epoetin versus darbepoetin Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

8.1 Epoetin	67	11786	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]
8.2 Darbepoetin	21	4307	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.60, 0.72]
9 Participants receiving red blood cell transfusions ‐ duration of ESA medication Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

9.1 6 to 9 weeks	13	815	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.49, 0.74]
9.2 12 to 16 weeks	52	8413	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.61, 0.69]
9.3 more than 17 weeks	23	6865	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.61, 0.70]
10 Participants receiving red blood cell transfusions ‐ iron supplementation Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

10.1 fixed iron supplementation	10	2104	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.49, 0.70]
10.2 iron supplementation as necessary	63	12060	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.65, 0.71]
10.3 no explicit statement on iron supplementation or no iron given	11	645	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.42, 0.65]
10.4 explicitly stated NO IRON	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.5 iron given differently in both study arms new	4	1284	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.43, 0.61]
11 Participants receiving red blood cell transfusions ‐ allocation concealment Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

11.1 adequate	55	10898	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.58, 0.65]
11.2 unclear	33	5195	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.67, 0.76]
12 Participants receiving red blood cell transfusions ‐ masking Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

12.1 double‐blind	50	9677	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.68, 0.75]
12.2 unblinded	38	6416	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.47, 0.56]
13 Participants receiving red blood cell transfusions ‐ intention‐to treat Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

13.1 ITT or less than 10% of participants per study arm excluded	73	13772	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.63, 0.69]
13.2 more than 10% of participants per study arm excluded	11	1035	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.36, 0.63]
13.3 unclear	4	1286	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.33, 0.62]
14 Participants receiving red blood cell transfusions ‐ publication Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

14.1 fulltext publication	65	12678	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.63, 0.70]
14.2 abstract publication	7	1242	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.32, 0.49]
14.3 unpublished data	14	1658	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.67, 0.80]
14.4 FDA presented data	1	314	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.47, 0.78]
14.5 Other	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.26, 0.73]
15 Participants receiving red blood cell transfusions ‐ first 4 weeks are... Show forest plot	88	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

15.1 included in the analysis	32	5319	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.61, 0.70]
15.2 excluded from the analysis	23	3288	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.61, 0.75]
15.3 unclear	33	7486	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.60, 0.68]
16 Participants receiving red blood cell transfusions ‐ experimental arms merged Show forest plot	70	16093	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.62, 0.68]

Comparison 3. Participants receiving red blood cell transfusions

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Comparison 4. Number of red blood cell units transfused per patient

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of RBC units transfused ‐ overall Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

2 Number of RBC units transfused ‐ baseline Hb Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

2.1 Hb < 10g/dL	16	1996	Mean Difference (IV, Fixed, 95% CI)	‐1.02 [‐1.35, ‐0.68]
2.2 Hb 10 to 12g/dL	5	1096	Mean Difference (IV, Fixed, 95% CI)	‐0.95 [‐1.24, ‐0.65]
2.3 Hb > 12g/dL	4	1623	Mean Difference (IV, Fixed, 95% CI)	‐0.97 [‐1.41, ‐0.54]
3 Number of RBC units transfused ‐ age differentiated Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

3.1 only children <18 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 adults ≥18 years	21	3093	Mean Difference (IV, Fixed, 95% CI)	‐0.81 [‐1.04, ‐0.57]
3.3 >68% non‐elderly 18‐65 years	3	353	Mean Difference (IV, Fixed, 95% CI)	‐1.25 [‐1.72, ‐0.77]
3.4 only non‐elderly adults	1	1269	Mean Difference (IV, Fixed, 95% CI)	‐1.60 [‐2.18, ‐1.02]
3.5 >68% elderly >65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.6 only elderly > 65 J	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Number of RBC units transfused ‐ age Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

4.1 adults	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]
5 Number of RBC units transfused ‐ different malignancies Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

5.1 solid tumours	10	1437	Mean Difference (IV, Fixed, 95% CI)	‐1.07 [‐1.34, ‐0.80]
5.2 haematological malignancies	10	2254	Mean Difference (IV, Fixed, 95% CI)	‐1.19 [‐1.63, ‐0.76]
5.3 mixed	5	1024	Mean Difference (IV, Fixed, 95% CI)	‐0.62 [‐1.01, ‐0.24]
6 Number of RBC units transfused ‐ different therapies Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

6.1 chemotherapy	23	4376	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.18, ‐0.78]
6.2 radiotherapy/radiochemotherapy	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 no therapy	1	118	Mean Difference (IV, Fixed, 95% CI)	‐0.67 [‐1.81, 0.47]
6.4 unclear/ other	1	221	Mean Difference (IV, Fixed, 95% CI)	‐2.2 [‐6.44, 2.04]
7 Number of RBC units transfused ‐ different therapies differentiated Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

7.1 chemotherapy > 70% with platinum	10	1344	Mean Difference (IV, Fixed, 95% CI)	‐1.11 [‐1.40, ‐0.83]
7.2 chemotherapy, <70% with platinum	2	584	Mean Difference (IV, Fixed, 95% CI)	‐0.52 [‐0.93, ‐0.12]
7.3 chemotherapy without platinum	9	2054	Mean Difference (IV, Fixed, 95% CI)	‐1.23 [‐1.69, ‐0.78]
7.4 chemotherapy, platinum and non‐platinum containing, no numbers given	2	394	Mean Difference (IV, Fixed, 95% CI)	‐1.01 [‐1.80, ‐0.21]
7.5 chemotherapy no details given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.6 radiochemotherapy	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.7 radiotherapy	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.8 no therapy	1	118	Mean Difference (IV, Fixed, 95% CI)	‐0.67 [‐1.81, 0.47]
7.9 unclear/other	1	221	Mean Difference (IV, Fixed, 95% CI)	‐2.2 [‐6.44, 2.04]
8 Number of RBC units transfused ‐ epoetin versus darbepoetin Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

8.1 Epoetin	23	4052	Mean Difference (IV, Fixed, 95% CI)	‐1.06 [‐1.29, ‐0.82]
8.2 Darbepoetin	2	663	Mean Difference (IV, Fixed, 95% CI)	‐0.78 [‐1.15, ‐0.42]
9 Number of RBC units transfused ‐ duration of ESA medication Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

9.1 6 to 9 weeks	6	364	Mean Difference (IV, Fixed, 95% CI)	‐1.25 [‐1.75, ‐0.75]
9.2 12 to 16 weeks	12	2688	Mean Difference (IV, Fixed, 95% CI)	‐0.78 [‐1.03, ‐0.54]
9.3 more than 17 weeks	7	1663	Mean Difference (IV, Fixed, 95% CI)	‐1.40 [‐1.84, ‐0.95]
10 Number of RBC units transfused ‐ iron supplementation Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

10.1 fixed iron supplementation	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.2 iron supplementation as necessary	24	4402	Mean Difference (IV, Fixed, 95% CI)	‐0.92 [‐1.13, ‐0.72]
10.3 no explicit statement on iron supplementation or no iron given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.4 explicitely stated NO IRON	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.5 iron given differently in both study arms	1	313	Mean Difference (IV, Fixed, 95% CI)	‐1.6 [‐2.30, ‐0.90]
11 Number of RBC units transfused ‐ allocation concealment Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

11.1 adequate	15	2243	Mean Difference (IV, Fixed, 95% CI)	‐0.93 [‐1.19, ‐0.67]
11.2 unclear	10	2472	Mean Difference (IV, Fixed, 95% CI)	‐1.04 [‐1.35, ‐0.74]
12 Number of RBC units transfused ‐ masking Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

12.1 double‐blind	12	3382	Mean Difference (IV, Fixed, 95% CI)	‐0.91 [‐1.14, ‐0.69]
12.2 unblinded	13	1333	Mean Difference (IV, Fixed, 95% CI)	‐1.16 [‐1.55, ‐0.77]
13 Number of RBC units transfused ‐ intention‐to‐treat Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

13.1 ITT or less than 10% of participants per study arm excluded	24	4583	Mean Difference (IV, Fixed, 95% CI)	‐0.99 [‐1.19, ‐0.79]
13.2 more than 10% of participants per study arm excluded	1	132	Mean Difference (IV, Fixed, 95% CI)	‐0.69 [‐1.66, 0.28]
14 Number of RBC units transfused ‐ publication Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

14.1 full text publication	4	1200	Mean Difference (IV, Fixed, 95% CI)	‐0.77 [‐1.06, ‐0.48]
14.2 abstract publication	1	1269	Mean Difference (IV, Fixed, 95% CI)	‐1.60 [‐2.18, ‐1.02]
14.3 unpublished data	20	2246	Mean Difference (IV, Fixed, 95% CI)	‐1.03 [‐1.33, ‐0.73]
14.4 FDA presented data	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
15 Number of RBC units transfused ‐ first 4 weeks are... Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

15.1 included in the analysis	18	2658	Mean Difference (IV, Fixed, 95% CI)	‐0.99 [‐1.23, ‐0.74]
15.2 excluded from the analysis	3	623	Mean Difference (IV, Fixed, 95% CI)	‐0.53 [‐0.94, ‐0.12]
15.3 unclear	4	1434	Mean Difference (IV, Fixed, 95% CI)	‐1.72 [‐2.27, ‐1.18]
16 Number of RBC units transfused ‐ experimental arms merged Show forest plot	19	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

17 Number of RBC units transfused ‐ age differentiated sensitivity analysis Show forest plot	25	4715	Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.17, ‐0.78]

17.1 only children <18 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
17.2 adults ≥18 years	21	3093	Mean Difference (IV, Fixed, 95% CI)	‐0.81 [‐1.04, ‐0.57]
17.3 >68% non‐elderly 18‐65 years	4	1622	Mean Difference (IV, Fixed, 95% CI)	‐1.39 [‐1.75, ‐1.02]
17.4 only non‐elderly adults	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
17.5 >68% elderly >65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
17.6 only elderly > 65 J	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Number of red blood cell units transfused per patient

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Comparison 5. Overall survival

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall survival ‐ overall Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

2 Overall survival updated review (adjusted results) Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

3 Overall survival ‐ baseline Hb Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

3.1 Hb < 10 g/dL	29	6144	Peto Odds Ratio (95% CI)	1.06 [0.96, 1.17]
3.2 Hb 10 to 12 g/dL	31	6418	Peto Odds Ratio (95% CI)	1.01 [0.93, 1.10]
3.3 Hb > 12 g/dL	15	5725	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]
3.4 unclear	5	716	Peto Odds Ratio (95% CI)	0.83 [0.67, 1.03]
4 Overall survival ‐ different malignancies Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

4.1 solid tumours	50	11704	Peto Odds Ratio (95% CI)	1.06 [1.00, 1.13]
4.2 haematological malignancies	11	2901	Peto Odds Ratio (95% CI)	1.07 [0.90, 1.26]
4.3 MDS	1	66	Peto Odds Ratio (95% CI)	4.52 [0.38, 53.37]
4.4 mixed	18	4332	Peto Odds Ratio (95% CI)	1.02 [0.91, 1.15]
4.5 not reported	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
5 Overall survival ‐ age Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

5.1 children	1	222	Peto Odds Ratio (95% CI)	0.98 [0.14, 7.03]
5.2 adults	79	18781	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]
6 Overall survival ‐ age differentiated Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

6.1 only children < 18	1	222	Peto Odds Ratio (95% CI)	0.98 [0.14, 7.03]
6.2 adults >= 18	62	13975	Peto Odds Ratio (95% CI)	1.07 [1.01, 1.13]
6.3 > 68% non elderly 18‐65	11	1611	Peto Odds Ratio (95% CI)	0.86 [0.67, 1.10]
6.4 only non‐elderly adults	4	2916	Peto Odds Ratio (95% CI)	1.02 [0.82, 1.26]
6.5 > 68% elderly > 65	2	279	Peto Odds Ratio (95% CI)	0.77 [0.51, 1.17]
6.6 only elderly > 65	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
7 Overall survival ‐ different therapies Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

7.1 chemotherapy	55	13800	Peto Odds Ratio (95% CI)	1.04 [0.98, 1.11]
7.2 radiotherapy/radiochemotherapy	14	2939	Peto Odds Ratio (95% CI)	1.03 [0.92, 1.15]
7.3 no therapy	8	1942	Peto Odds Ratio (95% CI)	1.23 [1.04, 1.45]
7.4 unclear/other	3	322	Peto Odds Ratio (95% CI)	0.79 [0.49, 1.27]
8 Overall survival ‐ different therapies differentiated Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

8.1 chemotherapy, > 70% with platinum	19	3622	Peto Odds Ratio (95% CI)	1.01 [0.91, 1.12]
8.2 chemotherapy, < 70% with platinum	7	1812	Peto Odds Ratio (95% CI)	1.14 [0.95, 1.36]
8.3 chemotherapy without platinum (all patients)	19	6706	Peto Odds Ratio (95% CI)	1.08 [0.98, 1.19]
8.4 chemotherapy, platinum and non platinum containing, no numbers given	5	910	Peto Odds Ratio (95% CI)	0.94 [0.65, 1.37]
8.5 chemotherapy no details given	5	750	Peto Odds Ratio (95% CI)	0.82 [0.61, 1.10]
8.6 radiochemotherapy	8	1193	Peto Odds Ratio (95% CI)	0.92 [0.78, 1.09]
8.7 radiotherapy	6	1746	Peto Odds Ratio (95% CI)	1.12 [0.97, 1.30]
8.8 no therapy	8	1942	Peto Odds Ratio (95% CI)	1.23 [1.04, 1.45]
8.9 unclear/other	3	322	Peto Odds Ratio (95% CI)	0.79 [0.49, 1.27]
9 Overall survival ‐ epoetin vs darbepoetin Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

9.1 Epoetin	67	14047	Peto Odds Ratio (95% CI)	1.04 [0.98, 1.10]
9.2 Darbepoetin	13	4956	Peto Odds Ratio (95% CI)	1.09 [0.99, 1.20]
10 Overall survival ‐ duration of ESA medication Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

10.1 6 to 9 weeks	13	2244	Peto Odds Ratio (95% CI)	1.10 [0.95, 1.27]
10.2 12 to 16 weeks	46	9385	Peto Odds Ratio (95% CI)	1.05 [0.98, 1.13]
10.3 more than 17 weeks	18	6963	Peto Odds Ratio (95% CI)	1.04 [0.95, 1.14]
10.4 not reported	3	411	Peto Odds Ratio (95% CI)	1.10 [0.58, 2.07]
11 Overall survival ‐ iron supplementation Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

11.1 fixed iron supplementation	10	2348	Peto Odds Ratio (95% CI)	1.15 [0.99, 1.33]
11.2 iron supplementation as necessary	56	13888	Peto Odds Ratio (95% CI)	1.07 [1.01, 1.14]
11.3 iron handled differently in the study arms	9	2050	Peto Odds Ratio (95% CI)	0.96 [0.84, 1.11]
11.4 no explicit statement on iron supplementation or no iron given	5	717	Peto Odds Ratio (95% CI)	0.56 [0.38, 0.83]
11.5 explicitly stated NO IRON	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
12 Overall survival ‐ publication Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

12.1 full text publication	20	4531	Peto Odds Ratio (95% CI)	1.07 [0.92, 1.24]
12.2 abstract publication	3	1020	Peto Odds Ratio (95% CI)	1.09 [0.87, 1.37]
12.3 unpublished data	5	318	Peto Odds Ratio (95% CI)	0.73 [0.17, 3.05]
12.4 Data presented at FDA hearing	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
12.5 Data taken from IPD review (Bohlius 2009)	50	13018	Peto Odds Ratio (95% CI)	1.06 [1.00, 1.12]
12.6 clinical trial result information	1	60	Peto Odds Ratio (95% CI)	7.39 [0.15, 372.38]
12.7 other	1	56	Peto Odds Ratio (95% CI)	0.58 [0.33, 1.03]
13 Overall survival ‐ time‐to‐event or binary mortality data Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

13.1 binary mortality data at end of study	19	1917	Peto Odds Ratio (95% CI)	1.02 [0.66, 1.60]
13.2 Data from IPD review	50	13018	Peto Odds Ratio (95% CI)	1.06 [1.00, 1.12]
13.3 Cox regression analysis, Hazard ratio, log‐rank test, p‐value	7	3141	Peto Odds Ratio (95% CI)	1.07 [0.92, 1.25]
13.4 Survival curve and p‐value	4	927	Peto Odds Ratio (95% CI)	0.99 [0.78, 1.24]
14 Overall survival ‐ allocation concealment Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

14.1 adequate	47	12424	Peto Odds Ratio (95% CI)	1.08 [1.02, 1.14]
14.2 unclear	33	6579	Peto Odds Ratio (95% CI)	0.97 [0.87, 1.09]
15 Overall survival ‐ masking Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

15.1 double‐blind	42	10525	Peto Odds Ratio (95% CI)	1.06 [0.99, 1.14]
15.2 unblinded	38	8478	Peto Odds Ratio (95% CI)	1.04 [0.96, 1.12]
16 Overall survival ‐ intention‐to‐treat Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

16.1 ITT or less than 10% of participants per study arm excluded	75	18052	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]
16.2 more than 10% of participants per study arm excluded	2	385	Peto Odds Ratio (95% CI)	1.25 [0.92, 1.71]
16.3 Unclear	3	566	Peto Odds Ratio (95% CI)	0.49 [0.27, 0.89]
17 Overall survival ‐ follow up Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

17.1 follow up longer than on‐study mortality	44	13224	Peto Odds Ratio (95% CI)	1.05 [0.99, 1.10]
17.2 Short term follow up	36	5779	Peto Odds Ratio (95% CI)	1.14 [0.95, 1.36]
18 Overall survival ‐ follow up and design Show forest plot	80	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

18.1 Long term follow up and designed for long term follow up	25	9704	Peto Odds Ratio (95% CI)	1.06 [0.99, 1.12]
18.2 Long term follow up but not designed for long term follow up	11	2197	Peto Odds Ratio (95% CI)	1.02 [0.89, 1.18]
18.3 Long term follow up and design unclear	7	1142	Peto Odds Ratio (95% CI)	0.96 [0.79, 1.16]
18.4 Short term follow up but designed for long term follow up	3	1250	Peto Odds Ratio (95% CI)	1.32 [1.05, 1.66]
18.5 Short term follow up and not designed for long term follow up	34	4710	Peto Odds Ratio (95% CI)	0.97 [0.76, 1.23]
18.6 short term follow up and design unclear	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
19 Overall survival‐ experimental arms merged Show forest plot	78	19003	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]

20 Overall survival‐ experimental arms merged sens pos Show forest plot	76	17551	Peto Odds Ratio (95% CI)	1.04 [0.98, 1.10]

21 Overall survival‐ experimental arms merged sens neg Show forest plot	76	18018	Peto Odds Ratio (95% CI)	1.08 [1.02, 1.14]

22 Overall survival ‐ sensitivity analysis baseline Hb Show forest plot	75	18287	Peto Odds Ratio (95% CI)	1.07 [1.01, 1.13]

22.1 Hb < 10 g/dL	29	6144	Peto Odds Ratio (95% CI)	1.06 [0.96, 1.17]
22.2 Hb 10 to 12 g/dL	31	6418	Peto Odds Ratio (95% CI)	1.01 [0.93, 1.10]
22.3 Hb > 12 g/dL	15	5725	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]
23 Overall survival ‐ sensitivity analysis iron supplementation Show forest plot	75	18286	Peto Odds Ratio (95% CI)	1.07 [1.01, 1.12]

23.1 fixed iron supplementation	10	2348	Peto Odds Ratio (95% CI)	1.15 [0.99, 1.33]
23.2 iron supplementation as necessary	56	13888	Peto Odds Ratio (95% CI)	1.07 [1.01, 1.14]
23.3 iron handled differently in the study arms	9	2050	Peto Odds Ratio (95% CI)	0.96 [0.84, 1.11]
23.4 explicitly stated NO IRON	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
24 Overall survival ‐ sensitivity analysis intention‐to‐treat Show forest plot	77	18437	Peto Odds Ratio (95% CI)	1.06 [1.01, 1.12]

24.1 ITT or less than 10% of participants per study arm excluded	75	18052	Peto Odds Ratio (95% CI)	1.05 [1.00, 1.11]
24.2 more than 10% of participants per study arm excluded	2	385	Peto Odds Ratio (95% CI)	1.25 [0.92, 1.71]

Comparison 5. Overall survival

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Comparison 6. On‐study mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 On‐study mortality ‐ overall Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

2 On‐study mortality ‐ baseline Hb Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

2.1 Hb < 10 g/dL	28	5759	Peto Odds Ratio (95% CI)	1.12 [0.96, 1.32]
2.2 Hb 10 to 12 g/dL	26	5537	Peto Odds Ratio (95% CI)	1.09 [0.91, 1.29]
2.3 Hb > 12 g/dL	13	3923	Peto Odds Ratio (95% CI)	1.37 [1.12, 1.68]
2.4 unclear	5	716	Peto Odds Ratio (95% CI)	1.20 [0.75, 1.93]
3 On‐study mortality ‐ different malignancies Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

3.1 solid tumours	44	10056	Peto Odds Ratio (95% CI)	1.21 [1.06, 1.37]
3.2 haematological malignancies	10	1598	Peto Odds Ratio (95% CI)	1.13 [0.80, 1.59]
3.3 MDS	1	66	Peto Odds Ratio (95% CI)	4.52 [0.38, 53.37]
3.4 mixed	17	4215	Peto Odds Ratio (95% CI)	1.10 [0.92, 1.31]
3.5 not reported	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
4 On‐study mortality ‐ age Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

4.1 children	1	222	Peto Odds Ratio (95% CI)	0.98 [0.14, 7.03]
4.2 adults	71	15713	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]
5 On‐study mortality ‐ age differentiated Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

5.1 children	1	222	Peto Odds Ratio (95% CI)	0.98 [0.14, 7.03]
5.2 adults >= 18	59	13007	Peto Odds Ratio (95% CI)	1.18 [1.07, 1.31]
5.3 > 68% non elderly, 18‐65	10	1334	Peto Odds Ratio (95% CI)	0.76 [0.42, 1.35]
5.4 only non elderly adults	2	1372	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
5.5 > 68% elderly > 65 years	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
5.6 only elderly	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
6 On‐study mortality ‐ different therapies Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

6.1 chemotherapy	52	12058	Peto Odds Ratio (95% CI)	1.10 [0.98, 1.24]
6.2 radiotherapy/radiochemotherapy	10	1669	Peto Odds Ratio (95% CI)	1.48 [0.96, 2.27]
6.3 no therapy	8	1942	Peto Odds Ratio (95% CI)	1.34 [1.07, 1.66]
6.4 unclear/other	2	266	Peto Odds Ratio (95% CI)	1.48 [0.65, 3.37]
7 On‐study mortality ‐ different therapies differentiated Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

7.1 chemotherapy, > 70% with platinum	19	3622	Peto Odds Ratio (95% CI)	1.04 [0.85, 1.27]
7.2 chemotherapy, <70% with platinum	6	1475	Peto Odds Ratio (95% CI)	1.06 [0.76, 1.49]
7.3 chemotherapy without platinum, all patients	18	5418	Peto Odds Ratio (95% CI)	1.24 [1.04, 1.47]
7.4 chemotherapy, platinum and non‐platinum containing, no numbers given	4	793	Peto Odds Ratio (95% CI)	0.74 [0.40, 1.38]
7.5 chemotherapy, no details reported	5	750	Peto Odds Ratio (95% CI)	0.82 [0.50, 1.34]
7.6 radiochemotherapy	6	822	Peto Odds Ratio (95% CI)	1.46 [0.85, 2.51]
7.7 radiotherapy	4	847	Peto Odds Ratio (95% CI)	1.51 [0.75, 3.06]
7.8 no therapy	8	1942	Peto Odds Ratio (95% CI)	1.34 [1.07, 1.66]
7.9 unclear/other	2	266	Peto Odds Ratio (95% CI)	1.48 [0.65, 3.37]
8 On‐study mortality ‐ duration of ESA medication Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

8.1 6 to 9 weeks	9	1113	Peto Odds Ratio (95% CI)	0.95 [0.57, 1.59]
8.2 12 to 16 weeks	44	8992	Peto Odds Ratio (95% CI)	1.16 [1.02, 1.33]
8.3 more than 17 weeks	16	5419	Peto Odds Ratio (95% CI)	1.22 [1.04, 1.42]
8.4 not reported	3	411	Peto Odds Ratio (95% CI)	0.82 [0.38, 1.78]
9 On‐study mortality ‐ epoetin vs darbepoetin Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

9.1 Epoetin	60	11478	Peto Odds Ratio (95% CI)	1.16 [1.03, 1.30]
9.2 Darbepoetin	12	4457	Peto Odds Ratio (95% CI)	1.20 [1.00, 1.44]
10 On‐study mortality ‐ iron supplementation Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

10.1 fixed iron supplementation	8	1911	Peto Odds Ratio (95% CI)	1.20 [0.80, 1.81]
10.2 iron supplementation as necessary	53	11954	Peto Odds Ratio (95% CI)	1.17 [1.05, 1.30]
10.3 no explicit statement on iron supplementation or no iron given	3	276	Peto Odds Ratio (95% CI)	2.16 [0.72, 6.46]
10.4 explicitly stated no iron	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
10.5 iron handled differently in the study arms	8	1794	Peto Odds Ratio (95% CI)	1.09 [0.74, 1.60]
11 On‐study mortality ‐ publication Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

11.1 full text publication	14	1689	Peto Odds Ratio (95% CI)	0.97 [0.60, 1.57]
11.2 abstract publication	2	181	Peto Odds Ratio (95% CI)	7.64 [1.29, 45.03]
11.3 unpublished data	5	318	Peto Odds Ratio (95% CI)	1.65 [0.20, 13.32]
11.4 Data presented at FDA hearing	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
11.5 IPD Bohlius 2009	51	13747	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]
12 On‐study mortality ‐ time‐to‐event or binary mortality data Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

12.1 binary mortality data at end of study	21	2188	Peto Odds Ratio (95% CI)	1.14 [0.73, 1.79]
12.2 Results from IPD review	51	13747	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]
12.3 Cox regression analysis, Hazard ratio, log‐rank test, p‐value	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
12.4 Survival curve and p‐value	0	0	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
13 On‐study mortality ‐ allocation concealment Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

13.1 adequate	42	11144	Peto Odds Ratio (95% CI)	1.20 [1.08, 1.34]
13.2 unclear	30	4791	Peto Odds Ratio (95% CI)	1.03 [0.82, 1.30]
14 On‐study mortality ‐ masking Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

14.1 double‐blind	39	9049	Peto Odds Ratio (95% CI)	1.19 [1.06, 1.34]
14.2 unblinded	33	6886	Peto Odds Ratio (95% CI)	1.12 [0.94, 1.34]
15 On‐study mortality ‐ intention‐to‐treat Show forest plot	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

15.1 ITT or less than 10% of participants per study arm excluded	69	15706	Peto Odds Ratio (95% CI)	1.16 [1.05, 1.28]
15.2 more than 10% of participants per study arm excluded	1	48	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
15.3 Unclear	2	181	Peto Odds Ratio (95% CI)	7.64 [1.29, 45.03]
16 On‐study mortality ‐ sensitivity analysis ‐ follow‐up Show forest plot	80	19018	Peto Odds Ratio (95% CI)	1.16 [1.05, 1.27]

16.1 Short term follow subgroup	72	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]
16.2 Short term from Kaplan Meier curve	7	2966	Peto Odds Ratio (95% CI)	1.06 [0.60, 1.86]
16.3 Long term follow up	1	117	Peto Odds Ratio (95% CI)	0.94 [0.57, 1.54]
17 On‐study mortality ‐ sensitivity analysis experimental arms merged Show forest plot	70	15935	Peto Odds Ratio (95% CI)	1.17 [1.06, 1.29]

18 On‐study mortality ‐ sensitivity analysis intention‐to‐treat Show forest plot	70	15754	Peto Odds Ratio (95% CI)	1.16 [1.05, 1.28]

18.1 ITT or less than 10% of participants per study arm excluded	69	15706	Peto Odds Ratio (95% CI)	1.16 [1.05, 1.28]
18.2 more than 10% of participants per study arm excluded	1	48	Peto Odds Ratio (95% CI)	0.0 [0.0, 0.0]
19 On‐study mortality ‐ sensitivity analysis excluding Leyland and Smith Show forest plot	70	14007	Peto Odds Ratio (95% CI)	1.09 [0.97, 1.23]

Comparison 6. On‐study mortality

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Comparison 7. Complete tumour response

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Complete tumour response Show forest plot	19	5012	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.98, 1.06]

2 Tumour‐response specific quality criteria Show forest plot	19	5012	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.98, 1.06]

2.1 high quality	5	2476	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.95, 1.02]
2.2 low quality	14	2536	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.98, 1.36]
3 Complete tumour response ‐ experimental study arms merged Show forest plot	15	5012	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.98, 1.06]

Comparison 7. Complete tumour response

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Comparison 8. Change in FACT‐Fatigue 13

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change in FACT‐Fatigue (13 items) ‐ overall Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

2 Change in FACT‐Fatigue sensitivity analysis‐ Tsuboi Show forest plot	18	4967	Mean Difference (IV, Fixed, 95% CI)	2.10 [1.46, 2.75]

3 Change in FACT‐F 13 ‐ baseline Hb Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

3.1 Hb <= 10 g/dL	8	2484	Mean Difference (IV, Fixed, 95% CI)	1.66 [0.76, 2.55]
3.2 Hb 10 to 12 g/dL	9	2181	Mean Difference (IV, Fixed, 95% CI)	2.87 [1.89, 3.85]
3.3 Hb > 12 g/dL	1	300	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐2.63, 2.63]
3.4 Hb category unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Change in FACT‐F 13 ‐ different malignancies Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

4.1 solid tumours	9	2459	Mean Difference (IV, Fixed, 95% CI)	2.29 [1.33, 3.25]
4.2 haematological malignancies	2	566	Mean Difference (IV, Fixed, 95% CI)	1.99 [0.28, 3.69]
4.3 mixed	7	1940	Mean Difference (IV, Fixed, 95% CI)	1.87 [0.87, 2.87]
4.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Change in FACT‐F 13 ‐ age Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

5.1 only children < 18 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 adults >= 18 years	17	4627	Mean Difference (IV, Fixed, 95% CI)	1.82 [1.16, 2.49]
5.3 >70% non elderly 18‐65 years	1	338	Mean Difference (IV, Fixed, 95% CI)	5.1 [2.79, 7.41]
5.4 only non‐elderly adults	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.5 >70% elderly >65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.6 only elderly > 65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Change in FACT‐F 13 ‐ different therapies Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

6.1 chemotherapy	14	3515	Mean Difference (IV, Fixed, 95% CI)	2.79 [2.03, 3.55]
6.2 radiotherapy	1	300	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐2.63, 2.63]
6.3 no therapy	3	1150	Mean Difference (IV, Fixed, 95% CI)	0.42 [‐0.91, 1.76]
6.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Change in FACT‐F 13 ‐ different therapies differentiated Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.07 [1.43, 2.72]

7.1 chemotherapy, >70% with platinum	4	1069	Mean Difference (IV, Fixed, 95% CI)	1.85 [0.41, 3.30]
7.2 chemotherapy, <70% platinum containing	2	411	Mean Difference (IV, Fixed, 95% CI)	2.53 [‐0.01, 5.07]
7.3 chemotherapy without platinum (all patients)	6	1468	Mean Difference (IV, Fixed, 95% CI)	3.22 [2.12, 4.32]
7.4 chemotherapy, platinum and non‐platinum containing, no numbers given	3	567	Mean Difference (IV, Fixed, 95% CI)	3.27 [1.30, 5.23]
7.5 radiochemotherapy NEW	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.6 radiotherapy	1	300	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐2.63, 2.63]
7.7 no therapy	3	1150	Mean Difference (IV, Fixed, 95% CI)	0.42 [‐0.91, 1.76]
7.8 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.9 chemotherapy no details given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Change in FACT‐F 13 ‐ epoetin versus darbepoetin Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

8.1 Epoetin	11	2475	Mean Difference (IV, Fixed, 95% CI)	3.25 [2.33, 4.16]
8.2 Darbepoetin	7	2490	Mean Difference (IV, Fixed, 95% CI)	0.94 [0.04, 1.84]
9 Change in FACT‐F 13 ‐ duration of ESA medication Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

9.1 6 to 9 weeks	1	115	Mean Difference (IV, Fixed, 95% CI)	3.10 [‐0.27, 6.47]
9.2 12 to 16 weeks	15	4076	Mean Difference (IV, Fixed, 95% CI)	1.99 [1.30, 2.69]
9.3 more than 17 weeks	2	774	Mean Difference (IV, Fixed, 95% CI)	2.35 [0.46, 4.25]
9.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Change in FACT‐F 13 ‐ iron supplementation Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

10.1 fixed iron supplementation	4	863	Mean Difference (IV, Fixed, 95% CI)	1.64 [‐0.01, 3.29]
10.2 iron supplementation as necessary	13	3881	Mean Difference (IV, Fixed, 95% CI)	2.03 [1.32, 2.74]
10.3 no explicit statement on iron supplementation or no iron given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.4 explicitly stated NO IRON	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.5 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.6 iron given differently in both study arms new	1	221	Mean Difference (IV, Fixed, 95% CI)	5.15 [1.70, 8.60]
11 Change in FACT‐F 13 ‐ allocation concealment Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

11.1 adequate	16	4493	Mean Difference (IV, Fixed, 95% CI)	2.20 [1.51, 2.89]
11.2 unclear	2	472	Mean Difference (IV, Fixed, 95% CI)	1.20 [‐0.61, 3.02]
11.3 unclear wether adequate or unclear :)	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
12 Change in FACT‐F 13 ‐ masking Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

12.1 double‐blind	11	3384	Mean Difference (IV, Fixed, 95% CI)	1.33 [0.56, 2.10]
12.2 unblinded	7	1581	Mean Difference (IV, Fixed, 95% CI)	3.76 [2.60, 4.92]
13 Change in FACT‐F 13 ‐ intention‐to treat Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

13.1 ITT or less than 10% of participants per study arm excluded	4	864	Mean Difference (IV, Fixed, 95% CI)	3.30 [1.89, 4.70]
13.2 more than 10% of participants per study arm excluded	12	3689	Mean Difference (IV, Fixed, 95% CI)	1.80 [1.04, 2.56]
13.3 unclear	2	412	Mean Difference (IV, Fixed, 95% CI)	1.34 [‐0.95, 3.63]
14 Change in FACT‐F 13 ‐ publication Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

14.1 full text publication	16	4412	Mean Difference (IV, Fixed, 95% CI)	2.17 [1.49, 2.85]
14.2 abstract publication	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.3 unpublished data	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.4 FDA hearing	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.5 clinical trial result information	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.6 other source	2	553	Mean Difference (IV, Fixed, 95% CI)	1.32 [‐0.63, 3.26]
15 Change in FACT‐F 13 ‐ type of data Show forest plot	18	4965	Mean Difference (IV, Fixed, 95% CI)	2.08 [1.43, 2.72]

15.1 Not imputed data	7	2298	Mean Difference (IV, Fixed, 95% CI)	1.88 [0.96, 2.80]
15.2 Imputed data	11	2667	Mean Difference (IV, Fixed, 95% CI)	2.26 [1.36, 3.15]

Comparison 8. Change in FACT‐Fatigue 13

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Comparison 9. Change in FACT‐An 20

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change in FACT‐An (20 items) ‐ overall Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

2 Change in FACT‐An 20 ‐ baseline Hb Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

2.1 Hb <= 10 g/dL	1	290	Mean Difference (IV, Fixed, 95% CI)	6.6 [3.92, 9.28]
2.2 Hb 10 to 12 g/dL	4	713	Mean Difference (IV, Fixed, 95% CI)	5.82 [3.71, 7.93]
2.3 Hb > 12 g/dL	1	82	Mean Difference (IV, Fixed, 95% CI)	6.4 [0.83, 11.97]
2.4 Hb category unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Change in FACT‐An 20 ‐ different malignancies Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

3.1 solid tumours	5	795	Mean Difference (IV, Fixed, 95% CI)	5.90 [3.92, 7.87]
3.2 haematological malignancies	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 mixed	1	290	Mean Difference (IV, Fixed, 95% CI)	6.6 [3.92, 9.28]
3.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Change in FACT‐An 20 ‐ age Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

4.1 only children < 18 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 adults >= 18 years	5	747	Mean Difference (IV, Fixed, 95% CI)	5.93 [4.00, 7.86]
4.3 >70% non elderly 18‐65 years	1	338	Mean Difference (IV, Fixed, 95% CI)	6.59 [3.79, 9.39]
4.4 only non‐elderly adults	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.5 >70% elderly >65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.6 only elderly > 65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Change in FACT‐An 20 ‐ different therapies Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

5.1 chemotherapy	5	1051	Mean Difference (IV, Fixed, 95% CI)	6.21 [4.60, 7.82]
5.2 radiotherapy	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.3 no therapy	1	34	Mean Difference (IV, Fixed, 95% CI)	3.9 [‐5.75, 13.55]
5.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Change in FACT‐An 20 ‐ different therapies differentiated Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

6.1 chemotherapy, >70% with platinum	2	256	Mean Difference (IV, Fixed, 95% CI)	5.08 [1.12, 9.04]
6.2 chemotherapy, <70% platinum containing	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 chemotherapy without platinum (all patients)	4	795	Mean Difference (IV, Fixed, 95% CI)	6.43 [4.66, 8.19]
6.4 chemotherapy, platinum and non‐platinum containing, no numbers given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.5 radiochemotherapy NEW	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.6 radiotherapy	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.7 no therapy	1	34	Mean Difference (IV, Fixed, 95% CI)	3.9 [‐5.75, 13.55]
6.8 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.9 chemotherapy no details given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Change in FACT‐An 20 ‐ epoetin versus darbepoetin Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

7.1 Epoetin	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]
7.2 Darbepoetin	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Change in FACT‐An 20 ‐ duration of ESA medication Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

8.1 6 to 9 weeks	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.2 12 to 16 weeks	5	795	Mean Difference (IV, Fixed, 95% CI)	5.90 [3.92, 7.87]
8.3 more than 17 weeks	1	290	Mean Difference (IV, Fixed, 95% CI)	6.6 [3.92, 9.28]
8.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Change in FACT‐An 20 ‐ iron supplementation Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

9.1 fixed iron supplementation	1	126	Mean Difference (IV, Fixed, 95% CI)	3.53 [‐1.90, 8.96]
9.2 iron supplementation as necessary	4	744	Mean Difference (IV, Fixed, 95% CI)	6.48 [4.68, 8.28]
9.3 no explicit statement on iron supplementation or no iron given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.4 explicitly stated NO IRON	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.5 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.6 iron given differently in both study arms new	1	215	Mean Difference (IV, Fixed, 95% CI)	5.84 [1.47, 10.21]
10 Change in FACT‐An 20 ‐ allocation concealment Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

10.1 adequate	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]
10.2 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.3 unclear wether adequate or unclear :)	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
11 Change in FACT‐An 20 ‐ masking Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

11.1 double‐blind	3	406	Mean Difference (IV, Fixed, 95% CI)	6.41 [4.06, 8.75]
11.2 unblinded	3	679	Mean Difference (IV, Fixed, 95% CI)	5.92 [3.76, 8.08]
12 Change in FACT‐An 20 ‐ intention‐to treat Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

12.1 ITT or less than 10% of participants per study arm excluded	1	338	Mean Difference (IV, Fixed, 95% CI)	6.59 [3.79, 9.39]
12.2 more than 10% of participants per study arm excluded	5	747	Mean Difference (IV, Fixed, 95% CI)	5.93 [4.00, 7.86]
12.3 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
13 Change in FACT‐An 20 ‐ publication Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

13.1 full text publication	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]
13.2 abstract publication	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
13.3 unpublished data	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
13.4 FDA hearing	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
13.5 clinical trial result information	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14 Change in FACT‐An 20 ‐ data type Show forest plot	6	1085	Mean Difference (IV, Fixed, 95% CI)	6.14 [4.55, 7.73]

14.1 Not imputed data	3	635	Mean Difference (IV, Fixed, 95% CI)	6.38 [4.20, 8.55]
14.2 Imputed data	3	450	Mean Difference (IV, Fixed, 95% CI)	5.88 [3.54, 8.21]

Comparison 9. Change in FACT‐An 20

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Comparison 10. Change in FACT‐An Total 47

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change in FACT‐An Total (47 items) ‐ overall Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

2 Change in FACT‐An Total 47‐ sensitivity analysis Show forest plot	9	1715	Mean Difference (IV, Fixed, 95% CI)	3.46 [0.96, 5.96]

3 Change in FACT‐An Total 47 ‐ baseline Hb Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

3.1 Hb <= 10 g/dL	5	978	Mean Difference (IV, Fixed, 95% CI)	2.57 [‐0.63, 5.78]
3.2 Hb 10 to 12 g/dL	4	537	Mean Difference (IV, Fixed, 95% CI)	16.22 [12.14, 20.30]
3.3 Hb > 12 g/dL	1	300	Mean Difference (IV, Fixed, 95% CI)	1.90 [‐4.19, 7.99]
3.4 Hb category unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Change in FACT‐An Total 47 ‐ different malignancies Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

4.1 solid tumours	8	1437	Mean Difference (IV, Fixed, 95% CI)	7.21 [4.58, 9.84]
4.2 haematological malignancies	1	206	Mean Difference (IV, Fixed, 95% CI)	6.10 [‐1.67, 13.87]
4.3 mixed	1	172	Mean Difference (IV, Fixed, 95% CI)	5.7 [‐0.83, 12.23]
4.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Change in FACT‐An Total 47 ‐ age Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

5.1 only children < 18 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 adults >= 18 years	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]
5.3 >70% non elderly 18‐65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.4 only non‐elderly adults	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.5 >70% elderly >65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.6 only elderly > 65 years	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Change in FACT‐An Total 47 ‐ different therapies Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

6.1 chemotherapy	8	1415	Mean Difference (IV, Fixed, 95% CI)	3.77 [1.03, 6.51]
6.2 radiotherapy	1	300	Mean Difference (IV, Fixed, 95% CI)	1.90 [‐4.19, 7.99]
6.3 no therapy	1	100	Mean Difference (IV, Fixed, 95% CI)	29.90 [23.46, 36.34]
6.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Change in FACT‐An Total 47 ‐ different therapies differentiated Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

7.1 chemotherapy, >70% with platinum	3	352	Mean Difference (IV, Fixed, 95% CI)	6.91 [1.12, 12.70]
7.2 chemotherapy, <70% platinum containing	3	600	Mean Difference (IV, Fixed, 95% CI)	0.28 [‐3.90, 4.45]
7.3 chemotherapy without platinum (all patients)	3	463	Mean Difference (IV, Fixed, 95% CI)	6.10 [1.44, 10.76]
7.4 chemotherapy, platinum and non‐platinum containing, no numbers given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.5 radiochemotherapy NEW	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.6 radiotherapy	1	300	Mean Difference (IV, Fixed, 95% CI)	1.90 [‐4.19, 7.99]
7.7 no therapy	1	100	Mean Difference (IV, Fixed, 95% CI)	29.90 [23.46, 36.34]
7.8 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.9 chemotherapy no details given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Change in FACT‐An Total 47 ‐ epoetin versus darbepoetin Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

8.1 Epoetin	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]
8.2 Darbepoetin	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Change in FACT‐An Total 47 ‐ duration of ESA medication Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

9.1 6 to 9 weeks	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.2 12 to 16 weeks	8	1625	Mean Difference (IV, Fixed, 95% CI)	3.39 [0.83, 5.96]
9.3 more than 17 weeks	2	190	Mean Difference (IV, Fixed, 95% CI)	23.64 [18.05, 29.22]
9.4 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Change in FACT‐An Total 47 ‐ iron supplementation Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

10.1 fixed iron supplementation	7	1217	Mean Difference (IV, Fixed, 95% CI)	7.14 [4.31, 9.96]
10.2 iron supplementation as necessary	2	378	Mean Difference (IV, Fixed, 95% CI)	5.87 [0.86, 10.87]
10.3 no explicit statement on iron supplementation or no iron given	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.4 explicitly stated NO IRON	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.5 unclear	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.6 iron given differently in both study arms new	1	220	Mean Difference (IV, Fixed, 95% CI)	7.67 [0.40, 14.94]
11 Change in FACT‐An Total 47 ‐ allocation concealment Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

11.1 adequate	4	840	Mean Difference (IV, Fixed, 95% CI)	4.69 [0.92, 8.45]
11.2 unclear	6	975	Mean Difference (IV, Fixed, 95% CI)	8.30 [5.33, 11.26]
12 Change in FACT‐An Total 47 ‐ masking Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

12.1 double‐blind	6	1078	Mean Difference (IV, Fixed, 95% CI)	8.00 [5.13, 10.87]
12.2 unblinded	4	737	Mean Difference (IV, Fixed, 95% CI)	4.83 [0.84, 8.82]
13 Change in FACT‐An Total 47 ‐ intention‐to treat Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

13.1 ITT or less than 10% of participants per study arm excluded	4	585	Mean Difference (IV, Fixed, 95% CI)	10.85 [7.29, 14.41]
13.2 more than 10% of participants per study arm excluded	4	840	Mean Difference (IV, Fixed, 95% CI)	4.69 [0.92, 8.45]
13.3 unclear	2	390	Mean Difference (IV, Fixed, 95% CI)	2.54 [‐2.81, 7.90]
14 Change in FACT‐An Total 47 ‐ publication Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

14.1 full text publication	9	1725	Mean Difference (IV, Fixed, 95% CI)	7.02 [4.63, 9.40]
14.2 abstract publication	1	90	Mean Difference (IV, Fixed, 95% CI)	4.71 [‐6.49, 15.91]
14.3 unpublished data	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.4 FDA hearing	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
14.5 clinical trial result information	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
15 Change in Fact‐An Total 47 ‐ data type Show forest plot	10	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

15.1 Not imputed data	7	1101	Mean Difference (IV, Fixed, 95% CI)	9.31 [6.45, 12.17]
15.2 Imputed data	3	714	Mean Difference (IV, Fixed, 95% CI)	2.19 [‐1.83, 6.20]
16 FACT‐An Total 47 ‐ merged experimental study arms Show forest plot	9	1815	Mean Difference (IV, Fixed, 95% CI)	6.92 [4.59, 9.25]

Comparison 10. Change in FACT‐An Total 47

Ir a la tabla de la revisión

Comparison 11. Thrombotic events

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Thrombotic events ‐ overall Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

2 Thrombotic events ‐ baseline Hb Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

2.1 Hb < 10 g/dL	19	4231	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [1.06, 1.88]
2.2 Hb 10 to 12 g/dL	26	5491	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [1.33, 2.03]
2.3 Hb > 12 g/dL	13	5348	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [1.15, 1.80]
2.4 Hb unclear	2	428	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [1.02, 2.65]
3 Thrombotic events ‐ different malignancies Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

3.1 solid tumours	36	9121	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [1.41, 1.96]
3.2 haematological malignancies	8	2531	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.93, 1.90]
3.3 mixed	14	3693	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.98, 1.69]
3.4 MDS	2	153	Risk Ratio (M‐H, Fixed, 95% CI)	2.08 [0.23, 18.84]
3.5 not reported	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Thrombotic events ‐ age Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

4.1 children	1	222	Risk Ratio (M‐H, Fixed, 95% CI)	2.95 [0.61, 14.28]
4.2 adults	59	15276	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.33, 1.73]
5 Thrombotic events ‐ age differentiated Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

5.1 children	1	222	Risk Ratio (M‐H, Fixed, 95% CI)	2.95 [0.61, 14.28]
5.2 adults >= 18	46	11310	Risk Ratio (M‐H, Fixed, 95% CI)	1.60 [1.38, 1.86]
5.3 > 68% non elderly, 18‐65	7	1028	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [1.02, 2.86]
5.4 only non elderly	5	2882	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.86, 1.60]
5.5 > 68% elderly > 65 years	1	56	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.01, 4.58]
5.6 only elderly	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Thrombotic events ‐ different therapies Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

6.1 chemotherapy	37	10844	Risk Ratio (M‐H, Fixed, 95% CI)	1.48 [1.27, 1.73]
6.2 radiotherapy/radiochemotherapy	11	2384	Risk Ratio (M‐H, Fixed, 95% CI)	2.02 [1.44, 2.83]
6.3 no therapy	8	1921	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.88, 1.78]
6.4 unclear/other	4	349	Risk Ratio (M‐H, Fixed, 95% CI)	2.09 [0.74, 5.93]
7 Thrombotic events ‐ different therapies differentiated Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

7.1 chemotherapy, > 70% with platinum	16	3136	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [1.13, 1.89]
7.2 chemotherapy, < 70% with platinum	3	919	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [0.92, 2.88]
7.3 chemotherapy, without platinum, all patients	14	6085	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [1.14, 1.76]
7.4 chemotherapy, platinum and non platinum containing, no numbers given	2	265	Risk Ratio (M‐H, Fixed, 95% CI)	4.56 [0.79, 26.20]
7.5 chemotherapy no details given	2	439	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [0.67, 4.76]
7.6 radiochemotherapy	7	1097	Risk Ratio (M‐H, Fixed, 95% CI)	2.01 [1.37, 2.96]
7.7 radiotherapy	4	1287	Risk Ratio (M‐H, Fixed, 95% CI)	2.03 [1.02, 4.07]
7.8 no therapy	8	1921	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.88, 1.78]
7.9 unclear/other	4	349	Risk Ratio (M‐H, Fixed, 95% CI)	2.09 [0.74, 5.93]
8 Thrombotic events ‐ epoetin versus darbepoetin Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

8.1 Epoetin	50	11055	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [1.33, 1.85]
8.2 Darbepoetin	10	4443	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [1.16, 1.79]
9 Thrombotic events ‐ duration of ESA treatment Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

9.1 6 to 9 weeks	10	1719	Risk Ratio (M‐H, Fixed, 95% CI)	2.06 [1.17, 3.64]
9.2 12 to 16 weeks	30	7223	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [1.20, 1.77]
9.3 more than 17 weeks	19	6312	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [1.27, 1.84]
9.4 not reported	1	244	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [0.15, 13.85]
10 Thrombotic events ‐ iron supplementation Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

10.1 fixed iron supplementation	4	1445	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [0.92, 2.54]
10.2 iron supplementation as necessary	47	12073	Risk Ratio (M‐H, Fixed, 95% CI)	1.51 [1.31, 1.74]
10.3 no explicit statement on iron supplementation or no iron given	4	293	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [0.39, 4.06]
10.4 iron handled differently in the study arms	5	1687	Risk Ratio (M‐H, Fixed, 95% CI)	1.69 [1.12, 2.54]
10.5 explicitly stated NO IRON	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
11 Thrombotic events ‐ concealment of allocation Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

11.1 adequate	38	10494	Risk Ratio (M‐H, Fixed, 95% CI)	1.64 [1.40, 1.92]
11.2 unclear	22	5004	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [1.04, 1.65]
12 Thrombotic events ‐ masking Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

12.1 double‐blind	32	9209	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.19, 1.64]
12.2 unblinded	28	6289	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [1.43, 2.23]
13 Thrombotic events ‐ intention‐to‐treat Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

13.1 ITT or less than 10% of participants per study arm excluded	55	13182	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [1.30, 1.72]
13.2 more than 10% of participants per study arm excluded	3	1589	Risk Ratio (M‐H, Fixed, 95% CI)	1.59 [0.95, 2.66]
13.3 unclear	2	727	Risk Ratio (M‐H, Fixed, 95% CI)	1.82 [1.15, 2.89]
14 Thrombotic events ‐ publication Show forest plot	60	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.34, 1.74]

14.1 full text publication	35	8388	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [1.32, 1.87]
14.2 abstract publication	2	1343	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.70, 1.55]
14.3 unpublished data	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.06, 33.82]
14.4 data presented at ODAC hearing	21	5645	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [1.33, 2.08]
14.5 other	1	56	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.01, 4.58]
15 Thrombotic events ‐ experimental arms merged Show forest plot	57	15498	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [1.34, 1.74]

Comparison 11. Thrombotic events

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Comparison 12. Hypertension

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hypertension ‐ overall Show forest plot	37	7228	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [1.08, 1.56]

2 Hypertension ‐ merged experimental study arms Show forest plot	31	7228	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [1.09, 1.58]

3 Hypertension ‐ sensitivity analysis Dammacco Show forest plot	37	7228	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [1.10, 1.52]

4 Hypertension ‐ sensitivity analysis random effects Show forest plot	37	7228	Risk Ratio (M‐H, Random, 95% CI)	1.12 [0.94, 1.33]

5 Hypertension ‐ sensitivity analysis without Rose Show forest plot	36	7007	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [1.18, 1.97]

Comparison 12. Hypertension

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Comparison 13. Thrombocytopenia or haemorrhage

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Thrombocytopenia ‐ overall Show forest plot	24	4507	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.04, 1.42]

2 Thrombocytopenia ‐ merged experimental arms Show forest plot	21	4507	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.04, 1.41]

3 Thrombocytopenia ‐ sensitivity analysis random effects Show forest plot	24	4507	Risk Ratio (M‐H, Random, 95% CI)	1.18 [1.02, 1.36]

Comparison 13. Thrombocytopenia or haemorrhage

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Comparison 14. Rash

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Rash ‐ overall Show forest plot	18	2485	Risk Ratio (M‐H, Fixed, 95% CI)	1.49 [0.99, 2.24]

2 Rash ‐ merged experimental arms Show forest plot	16	2485	Risk Ratio (M‐H, Fixed, 95% CI)	1.50 [1.00, 2.27]

Comparison 14. Rash

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Comparison 15. Seizure

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Seizure ‐ overall Show forest plot	8	2890	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.42, 1.41]

Comparison 15. Seizure

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