Immunoglobulin prophylaxis in hematological malignancies and hematopoietic stem cell transplantation

Pia Raanani; Anat Gafter-Gvili; Mical Paul; Isaac Ben-Bassat; Leonard Leibovici; Ofer Shpilberg

doi:10.1002/14651858.CD006501.pub2

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Figure 1

Flow diagram

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Figure 2

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.1 All‐cause Mortality.

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Figure 3

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.2 All cause mortality 100 days.

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Figure 4

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.3 All‐cause Mortality at 1‐2years and more.

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Figure 5

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.4 All‐cause Mortality ‐ by type of HSCT.

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Figure 6

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.5 All cause mortality ‐by use of antifungal prophylaxis.

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Figure 7

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.6 All‐cause Mortality ‐ high dose IVIG.

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Figure 8

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.7 All‐cause Mortality ‐sensitivity analysis by randomization generation.

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Figure 9

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.8 All‐cause Mortality ‐sensitivity analysis by double blinding.

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Figure 10

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.22 All‐cause Mortality ‐sensitivity analysis by ITT.

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Figure 11

Funnel plot: all cause mortality, IVIG vs. no treatment, HSCT

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Figure 12

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.9 Clinically documented infections.

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Figure 13

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.24 Clinically Documented Infections‐ sensitivity analysis by randomization generation.

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Figure 14

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.25 Clinically documented infections ‐ sensitivity analysis by blinding.

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Figure 15

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.10 Microbiologically documented infections ‐ bacterial.

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Figure 16

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.11 Microbiologically documented infections ‐ patient months.

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Figure 17

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.12 CMV infections.

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Figure 18

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.20 CMV Infections and Interstitial pneumonitis.

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Figure 19

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.23 CMV Infections, Interstitial pneumonitis and VOD.

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Figure 20

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.13 CMV infections ‐ patient months.

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Figure 21

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.14 Interstitial Pneumonitis.

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Figure 22

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.28 IP ‐ sensitivity analysis by randomization generation.

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Figure 23

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.29 IP ‐ sensitivity analysis by blinding.

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Figure 24

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.15 Infection‐related Mortality.

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Figure 25

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.16 Acute GVHD.

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Figure 26

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.17 VOD.

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Figure 27

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.19 VOD according to type of transplant.

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Figure 28

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.26 VOD ‐ sensitivity analysis according to randomization generation.

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Figure 29

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.27 VOD ‐ sensitivity analysis by blinding.

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Figure 30

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.18 Adverse Events.

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Figure 31

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.30 Fungal Infections.

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Figure 32

Forest plot of comparison: 1 Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, outcome: 1.31 Bacteremia.

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Figure 33

Forest plot of comparison: 2 Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 2.1 All‐cause Mortality.

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Figure 34

Forest plot of comparison: 2 Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 2.2 All‐cause Mortality ‐ 100d (3‐4mo).

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Figure 35

Forest plot of comparison: 2 Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 2.3 CMV infection.

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Figure 36

Forest plot of comparison: 2 Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 2.4 Interstitial Pneumonitis.

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Figure 37

Forest plot of comparison: 2 Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 2.5 Infection‐related Mortality.

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Figure 38

Forest plot of comparison: 2 Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 2.6 Acute GVHD.

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Figure 39

Forest plot of comparison: 2 Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 2.8 Fungal Infections.

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Figure 40

Forest plot of comparison: 3 Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 3.1 All‐cause Mortality.

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Figure 41

Forest plot of comparison: 3 Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 3.2 All‐cause Mortality ‐ 100d (3‐4 mo).

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Figure 42

Forest plot of comparison: 3 Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 3.3 CMV infection.

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Figure 43

Forest plot of comparison: 3 Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 3.4 Interstitial Pneumonitis.

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Figure 44

Forest plot of comparison: 3 Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 3.5 Infection‐related Mortality.

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Figure 45

Forest plot of comparison: 3 Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 3.6 Acute GVHD.

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Figure 46

Forest plot of comparison: 3 Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, outcome: 3.7 Adverse Events.

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Figure 47

Forest plot of comparison: 4 Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, outcome: 4.1 All‐cause Mortality.

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Figure 48

Forest plot of comparison: 4 Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, outcome: 4.3 CMV Infection.

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Figure 49

Forest plot of comparison: 4 Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, outcome: 4.4 Interstitial Pneumonitis.

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Figure 50

Forest plot of comparison: 4 Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, outcome: 4.5 Infection‐related Mortality.

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Figure 51

Forest plot of comparison: 4 Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, outcome: 4.6 Acute GVHD.

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Figure 52

Forest plot of comparison: 5 Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, outcome: 5.2 Clinically documented Infection.

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Figure 53

Forest plot of comparison: 5 Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, outcome: 5.3 Microbiologically documented Infection.

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Figure 54

Forest plot of comparison: 5 Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, outcome: 5.5 Interstitial Pneumonitis.

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Figure 55

Forest plot of comparison: 5 Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, outcome: 5.8 Acute GVHD.

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Figure 56

Forest plot of comparison: 6 Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, outcome: 6.1 All‐cause Mortality.

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Figure 57

Forest plot of comparison: 6 Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, outcome: 6.2 Clinically‐documented infections.

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Figure 58

Forest plot of comparison: 6 Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, outcome: 6.3 Microbiologically‐documented infections.

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Figure 59

Forest plot of comparison: 6 Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, outcome: 6.4 Bacteremia.

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Figure 60

Forest plot of comparison: 6 Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, outcome: 6.6 Adverse Events.

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Figure 61

Forest plot of comparison: 6 Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, outcome: 6.7 Adverse Events requiring discontinuation.

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Analysis 1.1

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 1: All‐cause Mortality

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Analysis 1.2

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 2: All cause mortality 100 days

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Analysis 1.3

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 3: All‐cause Mortality at 1‐2years and more

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Analysis 1.4

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 4: All‐cause Mortality ‐ by type of HSCT

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Analysis 1.5

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 5: All cause mortality ‐by use of antifungal prophylaxis

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Analysis 1.6

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 6: All‐cause Mortality ‐ high dose IVIG

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Analysis 1.7

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 7: All‐cause Mortality ‐sensitivity analysis by randomization generation

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Analysis 1.8

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 8: All‐cause Mortality ‐sensitivity analysis by double blinding

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Analysis 1.9

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 9: Clinically documented infections

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Analysis 1.10

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 10: Microbiologically documented infections ‐ bacterial

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Analysis 1.11

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 11: Microbiologically documented infections ‐ patient months

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Analysis 1.12

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 12: CMV infections

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Analysis 1.13

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 13: CMV infections ‐ patient months

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Analysis 1.14

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 14: Interstitial Pneumonitis

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Analysis 1.15

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 15: Infection‐related Mortality

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Analysis 1.16

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 16: Acute GVHD

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Analysis 1.17

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 17: VOD

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Analysis 1.18

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 18: Adverse Events

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Analysis 1.19

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 19: VOD according to type of transplant

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Analysis 1.20

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 20: CMV Infections and Interstitial pneumonitis

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Analysis 1.21

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 21: acute GVHD and VOD

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Analysis 1.22

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 22: All‐cause Mortality ‐sensitivity analysis by ITT

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Analysis 1.23

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 23: CMV Infections, Interstitial pneumonitis and VOD

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Analysis 1.24

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 24: Clinically Documented Infections‐ sensitivity analysis by randomization generation

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Analysis 1.25

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 25: Clinically documented infections ‐ sensitivity analysis by blinding

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Analysis 1.26

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 26: VOD ‐ sensitivity analysis according to randomization generation

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Analysis 1.27

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 27: VOD ‐ sensitivity analysis by blinding

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Analysis 1.28

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 28: IP ‐ sensitivity analysis by randomization generation

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Analysis 1.29

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 29: IP ‐ sensitivity analysis by blinding

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Analysis 1.30

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 30: Fungal Infections

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Analysis 1.31

Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 31: Bacteremia

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Analysis 2.1

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 1: All‐cause Mortality

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Analysis 2.2

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 2: All‐cause Mortality ‐ 100d (3‐4mo)

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Analysis 2.3

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 3: CMV infection

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Analysis 2.4

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 4: Interstitial Pneumonitis

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Analysis 2.5

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 5: Infection‐related Mortality

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Analysis 2.6

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 6: Acute GVHD

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Analysis 2.7

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 7: Adverse Events

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Analysis 2.8

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 8: Fungal Infections

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Analysis 2.9

Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 9: Bacteremia

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Analysis 3.1

Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 1: All‐cause Mortality

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Analysis 3.2

Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 2: All‐cause Mortality ‐ 100d (3‐4 mo)

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Analysis 3.3

Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 3: CMV infection

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Analysis 3.4

Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 4: Interstitial Pneumonitis

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Analysis 3.5

Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 5: Infection‐related Mortality

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Analysis 3.6

Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 6: Acute GVHD

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Analysis 3.7

Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 7: Adverse Events

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Analysis 4.1

Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 1: All‐cause Mortality

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Analysis 4.2

Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 2: Clinically documented Infection

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Analysis 4.3

Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 3: CMV Infection

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Analysis 4.4

Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 4: Interstitial Pneumonitis

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Analysis 4.5

Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 5: Infection‐related Mortality

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Analysis 4.6

Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 6: Acute GVHD

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Analysis 5.1

Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 1: All‐cause Mortality

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Analysis 5.2

Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 2: Clinically documented Infection

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Analysis 5.3

Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 3: Microbiologically documented Infection

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Analysis 5.4

Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 4: CMV Infection

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Analysis 5.5

Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 5: Interstitial Pneumonitis

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Analysis 5.6

Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 6: Infection related Mortality

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Analysis 5.7

Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 7: Acute GVHD

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Analysis 6.1

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 1: All‐cause Mortality

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Analysis 6.2

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 2: Clinically‐documented infections

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Analysis 6.3

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 3: Microbiologically‐documented infections

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Analysis 6.4

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 4: Bacteremia

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Analysis 6.5

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 5: Infection‐related Mortality

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Analysis 6.6

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 6: Adverse Events

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Analysis 6.7

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 7: Adverse Events requiring discontinuation

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Analysis 6.8

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 8: Clinically and microbiologically documented infections

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Analysis 6.9

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 9: Fungal infections

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Analysis 6.10

Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 10: Bacteremia

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Comparison 1. Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 All‐cause Mortality Show forest plot	8	1418	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.88, 1.12]

1.1.1 2 years and more	3	474	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.87, 1.15]
1.1.2 100‐200 days	5	944	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.81, 1.20]
1.2 All cause mortality 100 days Show forest plot	4	881	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.83, 1.26]

1.3 All‐cause Mortality at 1‐2years and more Show forest plot	5	737	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.94, 1.21]

1.4 All‐cause Mortality ‐ by type of HSCT Show forest plot	6	907	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.89, 1.18]

1.4.1 allogeneic transplant	3	305	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.79, 1.44]
1.4.2 autologous and allo transplant	2	432	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.81, 1.10]
1.4.3 autologous alone	1	170	Risk Ratio (M‐H, Fixed, 95% CI)	3.93 [1.14, 13.61]
1.5 All cause mortality ‐by use of antifungal prophylaxis Show forest plot	5	758	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.79, 1.04]

1.5.1 Use of oral polyene	2	251	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.74, 1.53]
1.5.2 no antifungal prophylaxis	3	507	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.76, 1.02]
1.6 All‐cause Mortality ‐ high dose IVIG Show forest plot	3	590	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.91, 1.23]

1.7 All‐cause Mortality ‐sensitivity analysis by randomization generation Show forest plot	8	1445	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.86, 1.09]

1.7.1 randomization generation A	2	370	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.88, 2.22]
1.7.2 randomization generation B	6	1075	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.05]
1.8 All‐cause Mortality ‐sensitivity analysis by double blinding Show forest plot	8	1445	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.86, 1.09]

1.8.1 double blinding	2	697	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.76, 1.17]
1.8.2 no blinding	6	748	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.86, 1.14]
1.9 Clinically documented infections Show forest plot	5	688	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.90, 1.10]

1.10 Microbiologically documented infections ‐ bacterial Show forest plot	7	1186	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.88, 1.15]

1.11 Microbiologically documented infections ‐ patient months Show forest plot	6	3542	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.82, 1.16]

1.12 CMV infections Show forest plot	6	986	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.66, 1.07]

1.13 CMV infections ‐ patient months Show forest plot	4	2082	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.49, 1.02]

1.14 Interstitial Pneumonitis Show forest plot	7	990	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.45, 0.89]

1.15 Infection‐related Mortality Show forest plot	3	275	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.28, 1.49]

1.16 Acute GVHD Show forest plot	7	989	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.04]

1.17 VOD Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	2.73 [1.11, 6.71]

1.18 Adverse Events Show forest plot	5	728	Risk Ratio (M‐H, Fixed, 95% CI)	8.12 [3.15, 20.97]

1.19 VOD according to type of transplant Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	2.73 [1.11, 6.71]

1.19.1 allo	3	277	Risk Ratio (M‐H, Fixed, 95% CI)	2.04 [0.76, 5.49]
1.19.2 auto	1	170	Risk Ratio (M‐H, Fixed, 95% CI)	11.80 [0.66, 210.03]
1.20 CMV Infections and Interstitial pneumonitis Show forest plot	8		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.20.1 CMV infections	6	986	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.66, 1.07]
1.20.2 Interstitial pneumonitis	7	990	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.45, 0.89]
1.21 acute GVHD and VOD Show forest plot	9		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.21.1 Acute GVHD	7	989	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.04]
1.21.2 VOD	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	2.73 [1.11, 6.71]
1.22 All‐cause Mortality ‐sensitivity analysis by ITT Show forest plot	9		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.22.1 ITT	6	986	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.87, 1.24]
1.22.2 PER PROTOCOL	3	473	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.79, 1.06]
1.23 CMV Infections, Interstitial pneumonitis and VOD Show forest plot	10		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.23.1 CMV infections	6	986	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.66, 1.07]
1.23.2 Interstitial pneumonitis	7	990	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.45, 0.89]
1.23.3 VOD	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	2.73 [1.11, 6.71]
1.24 Clinically Documented Infections‐ sensitivity analysis by randomization generation Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.24.1 randomization generation A	2	370	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.86, 1.14]
1.24.2 Randomization Generation B	3	318	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.86, 1.17]
1.25 Clinically documented infections ‐ sensitivity analysis by blinding Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.25.1 Double blind	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.91, 1.12]
1.25.2 no blinding	4	488	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.86, 1.15]
1.26 VOD ‐ sensitivity analysis according to randomization generation Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	2.73 [1.11, 6.71]

1.26.1 Randomization A	2	370	Risk Ratio (M‐H, Fixed, 95% CI)	3.35 [1.19, 9.47]
1.26.2 Randomization B	2	77	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.16, 7.51]
1.27 VOD ‐ sensitivity analysis by blinding Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	2.73 [1.11, 6.71]

1.27.1 double blind	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	2.44 [0.76, 7.82]
1.27.2 no blinding	3	247	Risk Ratio (M‐H, Fixed, 95% CI)	3.27 [0.78, 13.59]
1.28 IP ‐ sensitivity analysis by randomization generation Show forest plot	6	898	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.43, 0.87]

1.28.1 Randomization generation A	2	370	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [0.57, 4.85]
1.28.2 Randomization generation B	4	528	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.36, 0.76]
1.29 IP ‐ sensitivity analysis by blinding Show forest plot	7	990	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.45, 0.89]

1.29.1 double blind	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.56 [0.47, 5.19]
1.29.2 no blinding	6	790	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.41, 0.82]
1.30 Fungal Infections Show forest plot	5	1031	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.72, 1.25]

1.31 Bacteremia Show forest plot	4	653	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.93, 1.13]

Comparison 1. Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT

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Comparison 2. Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 All‐cause Mortality Show forest plot	4	288	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.63, 1.16]

2.2 All‐cause Mortality ‐ 100d (3‐4mo) Show forest plot	3	234	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.64, 1.24]

2.3 CMV infection Show forest plot	8	553	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.82, 1.26]

2.4 Interstitial Pneumonitis Show forest plot	5	345	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.58, 1.56]

2.5 Infection‐related Mortality Show forest plot	3	234	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.34, 1.32]

2.6 Acute GVHD Show forest plot	5	342	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.72, 1.44]

2.7 Adverse Events Show forest plot	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	7.00 [0.38, 129.34]

2.8 Fungal Infections Show forest plot	2	271	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.54, 1.93]

2.9 Bacteremia Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	1.76 [1.23, 2.52]

Comparison 2. Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT

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Comparison 3. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 All‐cause Mortality Show forest plot	12	1706	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.87, 1.09]

3.1.1 Polyvalent IVIG	8	1418	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.88, 1.12]
3.1.2 CMV‐IVIG	4	288	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.63, 1.16]
3.2 All‐cause Mortality ‐ 100d (3‐4 mo) Show forest plot	8	1178	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.82, 1.14]

3.2.1 Polyvalent IVIG	5	944	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.81, 1.20]
3.2.2 CMV‐IVIG	3	234	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.64, 1.24]
3.3 CMV infection Show forest plot	13	1511	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.76, 1.06]

3.3.1 Polyvalent IVIG	6	986	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.66, 1.07]
3.3.2 CMV‐IVIG	7	525	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.78, 1.21]
3.4 Interstitial Pneumonitis Show forest plot	12	1335	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.55, 0.95]

3.4.1 Polyvalent IVIG	7	990	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.45, 0.89]
3.4.2 CMV‐IVIG	5	345	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.58, 1.56]
3.5 Infection‐related Mortality Show forest plot	6	509	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.39, 1.12]

3.5.1 Polyvalent IVIG	3	275	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.28, 1.49]
3.5.2 CMV‐IVIG	3	234	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.34, 1.32]
3.6 Acute GVHD Show forest plot	12	1331	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.84, 1.05]

3.6.1 Polyvalent IVIG	7	989	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.04]
3.6.2 CMV‐IVIG	5	342	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.72, 1.44]
3.7 Adverse Events Show forest plot	6	782	Risk Ratio (M‐H, Fixed, 95% CI)	8.02 [3.25, 19.78]

3.7.1 Polyvalent IVIG	5	728	Risk Ratio (M‐H, Fixed, 95% CI)	8.12 [3.15, 20.97]
3.7.2 CMV‐IVIG	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	7.00 [0.38, 129.34]

Comparison 3. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT

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Comparison 4. Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 All‐cause Mortality Show forest plot	3	212	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [0.92, 2.32]

4.2 Clinically documented Infection Show forest plot	1	128	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [0.89, 2.79]

4.3 CMV Infection Show forest plot	3	212	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [1.07, 1.89]

4.4 Interstitial Pneumonitis Show forest plot	2	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.40, 1.75]

4.5 Infection‐related Mortality Show forest plot	2	177	Risk Ratio (M‐H, Fixed, 95% CI)	3.28 [0.95, 11.26]

4.6 Acute GVHD Show forest plot	2	163	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.87, 1.75]

Comparison 4. Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT

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Comparison 5. Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 All‐cause Mortality Show forest plot	1	412	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.84, 1.25]

5.2 Clinically documented Infection Show forest plot	2	509	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.81, 0.97]

5.3 Microbiologically documented Infection Show forest plot	2	509	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [1.04, 1.57]

5.4 CMV Infection Show forest plot	1	412	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.34, 1.41]

5.5 Interstitial Pneumonitis Show forest plot	2	509	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.33, 2.92]

5.6 Infection related Mortality Show forest plot	1	412	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.47, 1.43]

5.7 Acute GVHD Show forest plot	3	841	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [1.13, 1.55]

Comparison 5. Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT

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Comparison 6. Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 All‐cause Mortality Show forest plot	2	163	Risk Ratio (M‐H, Fixed, 95% CI)	1.36 [0.58, 3.19]

6.2 Clinically‐documented infections Show forest plot	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.39, 0.61]

6.3 Microbiologically‐documented infections Show forest plot	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.53, 0.95]

6.4 Bacteremia Show forest plot	2	124	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.14, 3.07]

6.5 Infection‐related Mortality Show forest plot	1	82	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.95]

6.6 Adverse Events Show forest plot	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	2.37 [1.74, 3.24]

6.7 Adverse Events requiring discontinuation Show forest plot	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	5.43 [0.70, 42.24]

6.8 Clinically and microbiologically documented infections Show forest plot	3	410	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.48, 0.69]

6.8.1 Clinically‐documented infections	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.39, 0.61]
6.8.2 Microbiologically‐documented infections	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.53, 0.95]
6.9 Fungal infections Show forest plot	1	81	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [0.26, 8.30]

6.10 Bacteremia Show forest plot	1	82	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.68]

Comparison 6. Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL

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