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

Profilaxis con inmunoglobulinas para las neoplasias hematológicas y el trasplante de células madre hematopoyéticas

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Referencias

Referencias de los estudios incluidos en esta revisión

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Abdel-Mageed A, Graham-Pole J, Del Rosario ML, Longmate J, Ochoa S, Amylon M, Elfenbein GJ, Janiec J, Jansen J, Lazarus HM. Comparison of two doses of intravenous immunoglobulin after allogeneic bone marrow transplants. Bone marrow transplantation 1999;23(9):929-32.

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PubMed

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Bowden, RA, Fisher, LD, Rogers, K, Cays, M, Meyers, JD. Cytomegalovirus (CMV)-specific intravenous immunoglobulin for the prevention of primary CMV infection and disease after marrow transplant. The Journal of infectious diseases 1991;164(3):483-7.

Chapel, HM, Lee, M, Hargreaves, R, Pamphilon, DH, Prentice, AG. Randomised trial of intravenous immunoglobulin as prophylaxis against infection in plateau-phase multiple myeloma. The UK Group for Immunoglobulin Replacement Therapy in Multiple Myeloma. Lancet 1994;343(8905):1059-63.

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Sullivan, K, Seidel, K, Jocom, J, Anasetti, C, Hnasen, J, Storb, R, Messner, H, Ndemanee, A, Goldman, J, Kolb, H, Beatty, P, Gluckman, E. Intravenous immunoglobulin (IVIG) prophylaxis in unrelated ddonor bone marrow transplantation(BMT): a phase III double-blind, Placebo-controlled multi-institutional trial. In: ASCO annual meeting abstract book. 2000:abstract 181.

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Winston, DJ, Pollard, RB, Ho, WG, Gallagher, JG, Rasmussen, LE, Huang, SN, Lin, CH, Gossett, TG, Merigan, TC, Gale, RP. Cytomegalovirus immune plasma in bone marrow transplant recipients. Annals of internal medicine 1982;97(1):11-8.

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Winston DJ, Ho WG, Lin GH et al Winston DJ, Ho WG, Lin GH et al [Use of a polyvalent intravenous immunoglobulin or specific cytomegalovirus hyperimmunoglobulin for modification of cytomegalovirus infections and prevention of interstitial pneumonias following bone marrow transplantation] Immun Infekt 1985, 13:296-301 Winston DJ, Ho WG, Lin GH et al. Use of a polyvalent intravenous immunoglobulin or specific cytomegalovirus hyperimmunoglobulin for modification of cytomegalovirus infections and prevention of interstitial pneumonias following bone marrow transplantation. Immunitat und Infektion 1985;13:296-301.

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Wolff SN, Fay JW, Herzig RH, Greer JP, Dummer S, Brown RA, Collins RH, Stevens DA, Herzig GP. High-dose weekly intravenous immunoglobulin to prevent infections in patients undergoing autologous bone marrow transplantation or severe myelosuppressive therapy. A study of the American Bone Marrow Transplant Group. Annals of internal medicine 1993;118(12):937-42.

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Referencias de los estudios excluidos de esta revisión

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Aulitzky, WE, Schulz, TF, Tilg, H, Niederwieser, D, Larcher, K, Ostberg, L, Scriba, M, Martindale, J, Stern, AC, Grass, P. Human monoclonal antibodies neutralizing cytomegalovirus (CMV) for prophylaxis of CMV disease: report of a phase I trial in bone marrow transplant recipients. The Journal of infectious diseases 1991;163(6):1344-7.

Bode, U, Erps, M, Liappis, N. Immunoglobulin administration as infection prevention in oncologic patients [Immunglobulingabe als infektionprophylaxe onkologischer patienten?]. Klinische P?diatrie 1986;198(6):476-8.

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Chapel HM, Lee M. Immunoglobulin replacement in patients with chronic lymphocytic leukemia (CLL):kinetics of immunoglobulin metabolism. Journal of clinical immunology 1992;12(1):17-20.

Chapel, HM, Hargreaves, R, Lee, M, Pamphilon, D. Intravenous immunoglobulin therapy in patients with multiple myeloma. Immunodeficiency 1993;4(1-4):77-8.

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Collins, PW, Slocombe, G, Wainwright, A, Newland, AC. A pilot study using intravenous immunoglobulin for the prevention of infection during remission induction in acute leukaemia. Leukemia & lymphoma 1991;6:25-30.

Collins, PW, Solocombe, G, Wainwright, A, Newland, AC. Intravenous immunoglobulin for infection prophylaxis in acute leukemia. In: British Journal of Haemaology. Vol. 77. 1991:75.

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PubMed

Cortez, K, Murphy, BR, Almeida, KN, Beeler, J, Levandowski, RA, Gill, VJ, Childs, RW, Barrett, AJ, Smolskis, M, Bennett, JE. Immune-globulin prophylaxis of respiratory syncytial virus infection in patients undergoing stem-cell transplantation. The Journal of infectious diseases 2002;186:834-8.

Eijkhout, HW, Der Meer, JW, Kallenberg, CG, Weening, RS, van Dissel, JT, Sanders, LA, Strengers, PF, Nienhuis, H, Schellekens, PT. The effect of two different dosages of intravenous immunoglobulin on the incidence of recurrent infections in patients with primary hypogammaglobulinemia. A randomized, double-blind, multicenter crossover trial. Annals of internal medicine 2001;135:165-74.

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Esperou, H, Brunot, A, Roudot-Thoraval, F, Buzyn, A, Dhedin, N, Rio, B, Chevret, S, Bassompierre, F, Gluckman, E, Cordonnier, C, Durand-Zaleski, I. Predicting the costs of allogeneic sibling stem-cell transplantation: results from a prospective, multicenter, French study. Transplantation 2004;77:1854-8.

Fehir, KM, Decker, WA, Samo, T, Young, JB, Lederer, E, Lawrence, EC. Immune globulin (GAMMAGARD) prophylaxis of CMV infections in patients undergoing organ transplantation and allogeneic bone marrow transplantation. Transplantation proceedings 1989;21(1 Pt 3):3107-9.

PubMed

Gamm, H, Huber, C, Chapel, H, Lee, M, Ries, F, Dicato, MA. Intravenous immune globulin in chronic lymphocytic leukaemia. Clinical and experimental immunology 1994;97 Suppl 1:17-20.

PubMed

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Gimesi, A, Eibl, M, Koos, R, Somlo, P, Magyarossy, E, Kardos, G, Fazekas, E, Schmidt, M, Borsi, J, Schuler, D. Immunoglobulin prophylaxis during intensive treatment of acute lymphoblastic leukemia in children. Acta Paediatrica Hungarica 1992;32(2):115-25.

PubMed

Graham-Pole, J, Camitta, B, Casper, J, Elfenbein, G, Gross, S, Herzig, R, Koch, P, Mahoney, D, Marcus, R, Munoz, L, Munoz, L, Pick, T, Spruce, W, Steuber, P, Weiner, R. Intravenous immunoglobulin may lessen all forms of infection in patients receiving allogeneic bone marrow transplantation for acute lymphoblastic leukemia: a pediatric oncology group study. Bone marrow transplantation 1988;3:559-66.

PubMed

Jurlander J, Geisler CH, Hansen MM. Treatment of hypogammaglobulinaemia in chronic lymphocytic leukaemia by low-dose intravenous gammaglobulin. European journal of haematology 1994;53(2):114-8.

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Nasman B, I, Fesel C, Brissac C, Lundkvist I. Prophylactic intravenous immunoglobulin treatment influences serum immunoglobulin M repertoire development after allogeneic bone marrow transplantation. Scandinavian journal of immunology 1999;50(1):73-82.

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Referencias adicionales

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estudios incluidos
estudios excluidos

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Winston DJ, Ho WG, Lin GH et al Winston DJ, Ho WG, Lin GH et al [Use of a polyvalent intravenous immunoglobulin or specific cytomegalovirus hyperimmunoglobulin for modification of cytomegalovirus infections and prevention of interstitial pneumonias following bone marrow transplantation] Immun Infekt 1985, 13:296-301 Winston DJ, Ho WG, Lin GH et al. Use of a polyvalent intravenous immunoglobulin or specific cytomegalovirus hyperimmunoglobulin for modification of cytomegalovirus infections and prevention of interstitial pneumonias following bone marrow transplantation. Immunit?t und Infektion 1985;13:296-301.

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Winston DJ, Ho WG, Champlin RE. Cytomegalovirus infections after allogeneic bone marrow transplantation. Reviews of infectious diseases 1990;12 Suppl 7:S776-S792.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

estudios excluidos

Abdel‐Mageed 1999

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: 18 pts.
Participants	350 patients with acute leukemia or CML who had allogeneic stem cell transplantation from sibling donors; Multi‐center ‐ 10 centers, USA Setting: hospitalization in isolation precautions with laminar air flow
Interventions	IV polyvalent Immunoglobulin in 2 doses. The trial included 2 arms: (50 mg/kg; 250 mg/kg; 500 mg/kg ) Schedule: weekly from day ‐8 to day +111 posttransplant (18 doses)
Outcomes	All cause mortality; CDI; CMV infections; relapse;
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Boeckh 2001

*Study characteristics*
Methods	Randomization generation: computer generated; Allocation concealment: sealed envelopes; Blinding: double blind Excluded: none
Participants	179 patients who had myeloablative allogeneic stem cell transplantation from sibling donors and unrelated donors; Multi‐center ‐ 3 centers, USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IV anti CMV specific monoclonal ab (MSL‐109) in 2 doses. The trial included 2 arms: 60 mg/kg and 15 mg/kg. Schedule: every 14 days from day ‐1 to day +84 post‐ransplant
Outcomes	All cause mortality; MDI; bacterial infections; fungal infections; bacteremia; CMV disease; hospitalization; IRM; acute GVHD; engraftment; relapse; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Bordigoni 1987

*Study characteristics*
Methods	Randomization generation: random numbers; Allocation concealment: opaque envelopes; Blinding: none; Excluded:none
Participants	60 patients who had myeloablative allogeneic and autologous bone marrow transplantation; Single center, France, Europe; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IV anti CMV IgG (Nancy) enriched plasma 4 ml/kg vs control. The trial included 2 arms: anti CMV IgG (Nancy) enriched plasma and control; Schedule: day ‐7, ‐3, 0 and then every 15 days to day 90 posttransplant
Outcomes	All cause mortality; CMV infection; IRM; IP; engraftment
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Boughton 1995

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: central ‐ from a reference center; Blinding: double blind Excluded: none
Participants	42 patients with CLL; Multi‐center ‐ 20 centers in UK, Europe; Setting: outpatients
Interventions	IV polyvalent Immunoglobulin (Sandoglobulin) vs placebo. The trial included 2 arms: IVIG 18 and placebo Schedule: every 3 weeks for 12 months
Outcomes	All cause mortality; CDI; MDI; bacterial infections; viral infections; bacteremia; immunoglobulin levels; adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Bowden 1986

*Study characteristics*
Methods	Randomization generation: protocol registrar using a table of random permutations; Allocation concealment: adequate measures to conceal allocation protocol registrar; Blinding: none; Excluded: 2 pts.
Participants	99 patients who had myeloablative allogeneic bone marrow transplantation, all recipients CMV negative; single center, USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	CMV immune globulin vs. control. The trial included 4 arms: CMV immune globulin (150 mg/kg) + seronegative blood products vs. seronegative blood products alone vs. CMV immune globulin alone (150 mg/kg) vs. control; Schedule: days ‐5, ‐1 , +6,+20, +34 ‐ dose of 150 mg/kg; days +48; +62 ‐ dose of 100 mg/kg posttransplant
Outcomes	All cause mortality; CMV infection; CMV disease;
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Bowden 1991

*Study characteristics*
Methods	Randomization generation: adequate‐protocol registrar using assignment from a table of random permutations; Allocation concealment:: unclear; Blinding: none; Excluded: 3 pts.
Participants	123 patients who had myeloablative allogeneic bone marrow transplantation for ALL, AML, CML, aplastic anemia, lymphoma and other; Single center: USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	CMV IVIG vs placebo. The trial included 2 arms: CMV IVIG (Cutter Biological) 200 mg/kg vs. placebo; Schedule: days ‐8; ‐6 pretransplant; +1; +7; +14; +21; +28; +42; +56; +70 posttransplant (10 doses)
Outcomes	All cause mortality; CMV infection; CMV disease; hospitalization; IRM; acute GVHD; IP
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Chapel 1994

*Study characteristics*
Methods	Randomization generation: randomization table for each study site; Allocation concealment: randomization code kept by pharmacy; Blinding: double blind Excluded: 1 pt.
Participants	83 multiple myeloma plateau phase patients; Multi‐center ‐9 centers, UK, Europe; Setting: Outpatients
Interventions	IVIG polyvalent Immunoglobulin (Gammagard) vs placebo. The trial included 2 arms: IVIG 0.4 g/kg vs. placebo Schedule: every 4 weeks for 12 months
Outcomes	All cause mortality; CDI; MDI; bacterial infections; bacteremia; IRM; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Chapel 1994c

*Study characteristics*
Methods	Randomization generation: table of random numbers; Allocation concealment: allocated centrally; Blinding: double blind Excluded: none
Participants	34 B‐CLL patients; Multi‐center‐ USA + Europe Setting: outpatients
Interventions	IVIG polyvalent Immunoglobulin (Gammagard) in 2 doses. The trial included 2 arms: (250 mg/kg; 500 mg/kg ) Schedule: every 4 weeks for 1 year
Outcomes	All cause mortality; CDI; MDI; bacterial infections; fungal infections; viral infection; immunoglobulin levels; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Condie 1984

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: none
Participants	55 patients who had myeloablative allogeneic myeloablative bone marrow transplantation for acute leukemia (AML + ALL) ; Multi‐center ‐ 2 centers; USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	Hyperimmune CMV IVIG vs. CMV deficient IVIG vs. control. The trial included 3 arms: Hyperimmune CMV IVIG 200 mg/kg vs. CMV deficient IVIG 200 mg/kg vs. control ‐ not randomized, matched control; Schedule: posttransplant days: +25; +50; +75
Outcomes	All cause mortality; CMV infection; CMV disease; acute GVHD; IP
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Cooperative CLL 1988

*Study characteristics*
Methods	Randomization generation: table of random numbers; Allocation concealment: allocated centrally; Blinding: double blind; Excluded: 3 pts.
Participants	84 CLL patients; Multi‐center ‐ 10 centers, USA & Europe Setting: outpatient
Interventions	IVIG polyvalent Immunoglobulin (Gammagard) vs placebo. The trial included 2 arms: IVIG 0.4 g/kg vs. placebo; Schedule: every 4 weeks for 12 months
Outcomes	All cause mortality; CDI; MDI; bacterial infections; IRM; adverse events bacteremia;
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Cordonnier 2003

*Study characteristics*
Methods	Randomization generation: computer generated; Allocation concealment: central randomization; Blinding: double blind Excluded:none
Participants	200 patients who had myeloablative allogeneic stem cell transplantation from HLA identical sibling donors; Multi‐center ‐ 19 centers; France,Europe Setting: hospitalization in isolation precautions and then outpatients
Interventions	IV polyvalent Immunoglobulin vs placebo. The trial included 4 arms: IVIG in 3 different doses (50 mg/kg; 250 mg/kg; 500 mg/kg ) and placebo Schedule: 16 weekly doses from ‐7d to day 100 post‐transplant
Outcomes	All cause mortality; CDI; MDI; bacterial infections; fungal infections; viral infections; CMV infections; CMV disease; TRM; acute GVHD; chronic GVHD; VOD; IP; engraftment; relapse; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Emanuel 1992

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: none
Participants	92 patients who had myeloablative allogeneic bone marrow transplantation single center; USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IV polyvalent Immunoglobulin (Gammagard) vs control. The trial included 2 arms: IVIG 500 mg/kg then 250 mg/kg and control; Schedule: 500 mg/kg every 2 weeks from day ‐7 to day +100 then 250 mg/kg from day +100 to day +180
Outcomes	All cause mortality; MDI; bacterial infections; CMV infections; CMV disease; IP; engraftment
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Feinstein 1999

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none Excluded: 19 pts.
Participants	260 patients who had myeloablative allogeneic bone marrow transplantation from HLA identical sibling donors; single center, USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IV polyvalent Immunoglobulin (Gamimmune) vs control. The trial included 2 arms: IVIG 500 mg/kg and control; Schedule: daily from days ‐6 to ‐1 then every 3rd day posttransplant from day +3 to day +90
Outcomes	All cause mortality; CDI; MDI; bacterial infections; fungal infections; viral infections; CMV infections; hospitalization; acute GVHD; engraftment; immunoglobulin levels; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Filipovich 1992

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: database personnel and pharmacy personnel; Blinding: double blind Excluded: none
Participants	42 patients who had autoBMT and alloBMT for acute leukemia, CML, other malignancy or non‐malignant disease; Single center, USA; Setting: inpatient
Interventions	IVIG polyvalent immunoglobulin products at a dose of 500 mg/kg. The trial included 4 arms: Gamimmune, Gammagard, Sandoglobulin, immune Globulin Intravenous; Schedule: every other week for 3 doses (week ‐1 to week +3);
Outcomes	CMV infections; immunoglobulin levels
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Gluck 1990

*Study characteristics*
Methods	Randomization generation: not specific; Allocation concealment: unclear; Blinding: none; Excluded: unknown
Participants	Unknown number of patients with multiple myeloma and low risk non‐Hodgkin lymphoma; single center, Europe, Germany; Setting: outpatients
Interventions	IV polyvalent Immunoglobulin vs placebo. The trial included 2 arms: IVIG (IVIG 0.5 ‐0.7 g/kg) and placebo Schedule: monthly for 6 months
Outcomes	Descriptive results on outcomes and not the exact numbers of patients who developed infections in each arm
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Graham Pole 1990

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none Excluded: 57 pts.
Participants	150 patients who had alloBMT from HLA matched and mismatched donors; Multi‐center ‐ 8 centers; USA; Setting: not reported
Interventions	IV polyvalent Immunoglobulin in 2 doses. The trial included 2 arms: 2 different doses (250 mg/kg; 500 mg/kg); Schedule: weekly from 1 week before to 16 weeks after BMT posttransplant
Outcomes	Authors reported on the total number of deaths in the study but not separately on the numbers in the 2 arms
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Hargreaves 1992

*Study characteristics*
Methods	Randomization generation: table of random numbers; Allocation concealment: allocated centrally; Blinding: double blind Excluded: unknown
Participants	39 patients with multiple myeloma patients; single center, UK, Europe; Setting: outpatients
Interventions	IVIG polyvalent immunoglobulin (Gammagard) vs. placebo. The trial included 2 arms: IVIG and placebo
Outcomes	Authors reported on the total rate of infections in both the treatment and the placebo arms
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Jacobsen 1985

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: none
Participants	49 patients who had myeloablative allogeneic bone marrow transplantation for ALL, AML, AUL, CML, lymphoma, SAA; Multi‐center ‐ 4 centers; Germany, Europe Setting: hospitalization in isolation precautions and then outpatients
Interventions	Hyperimmune CMV IVIG vs. control IG. The trial included 2 arms: Hyperimmune CMV IVIG 0.1 G protein/kg vs. control IG 0.1 G protein/kg; Schedule: day ‐7; day +13; day +33; day +53 ; day +79; day + 93
Outcomes	All cause mortality; CMV disease; IRM; acute GVHD; IP
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Lum 1994

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded:none
Participants	54 patients who had myeloablative allogeneic bone marrow transplantation; single center, USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IVIG polyvalent immunoglobulin vs. control. The trial included 2 arms: IVIG 400 mg/kg vs. control;Schedule: 10 weekly infusions from day +14 to day +79
Outcomes	All cause mortality; IRM; acute GVHD; chronic GVHD
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Meyers 1983

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: 6 pts.
Participants	68 patients with myeloablative allogeneitic BMT for acute leukemia and CML; Sincle‐center USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IM anti‐CMV hyperimmune globulin vs. control. The trial included 2 arms: anti‐CMV hyperimmune globulin and control; Schedule: on days ‐4 and ‐2 before BMT, then weekly to day +77 posttransplant
Outcomes	CMV infections; IRM; immunoglobulin levels
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Molica 1996

*Study characteristics*
Methods	Randomization generation:not specified; Allocation concealment: unclear; Blinding: none; Excluded: none
Participants	42 CLL patients; single center, Italy, Europe Setting: Outpatients
Interventions	IV polyvalent Immunoglobulin (Vena‐N) vs. control. The trial included 4 arms: Patients were randomly allocated to receive an infusion of IVIG every 4 weeks for at least 6 months or no treatment. Then they were switched to observation or IVIG for another 12 months; finally, they received IVIG or no therapy for 6 more months.
Outcomes	All cause mortality; CDI; MDI; IRM
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Musto 1995

*Study characteristics*
Methods	Randomization generation:not specified; Allocation concealment: unclear; blinding: none; Excluded: none
Participants	25 Multiple myeloma patients
Interventions	IV polyvalent Immunoglobulin (Vena‐N) vs. control. The trial included 8 arms: IVIG then no therapy then IVIG; IVIG then no therapy then no therapy; IVIG then IVIG then IVIG; IVIG then IVIG then no therapy; No therapy then no therapy then IVIG; No therapy then no therapy then no therapy No therapy then IVIG then IVIG No therapy then IVIG then no therapy Schedule: every 4 weeks for 6 months, then 4 weeks for 12 months then 4 weeks for 6 months
Outcomes	All cause mortality; CDI; IRM
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Peltier 1992

*Study characteristics*
Methods	Randomization generation:not specified; Allocation concealment: unclear ; Blinding: double blind Excluded: none
Participants	53 CMV ‐ seronegative patients who had undergone AutoBMT and AlloBMT for acute leukemia, CML, other malignancy or non‐malignant disease; Single ‐ center USA; Setting: not mentioned
Interventions	IVIG polyvalent immunoglobulin products at a dose of 500 mg/kg. The trial included 3 arms: Gammagard, Sandoglobulin, Gamimmune; Schedule: weekly starting the week before BMT, total 6 doses
Outcomes	No relevant outcomes (immunoglobulin levels)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Poynton 1992

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: 9 pts.
Participants	72 patients who had autologous or allogeneic bone marrow transplantation; Single center; UK, Europe Setting: hospitalization in isolation precautions and then outpatients
Interventions	IgM and IgA enriched IVIG Immunoglobulin vs control. The trial included 2 arms: IgM and IgA enriched IVIG and control; Schedule: days 0, +3, +7, then weekly until neutrophil > 0.5 x 10⁹/l
Outcomes	All cause mortality; CDI; MDI; bacterial infections; fungal infections; bacteremia; CMV disease; hospitalization; antibiotics; IRM; VOD; engraftment; relapse; immunoglobulin levels;
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Raiola 2002

*Study characteristics*
Methods	Randomization generation:not specified; Allocation concealment:: unclear; Blinding: none Excluded:none
Participants	89 patients who had allogenetic alternative donor bone marrow transplantation Single center ‐ Italy, Europe; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IVIG polyvalent immunoglobulin (Pentaglobulin) in 2 doses. The trial included 2 arms: IVIG 200 mg/kg and 400 mg/kg; Schedule: every 2 weeks from day ‐7 to day +100
Outcomes	All cause mortality; IRM; GVHD; relapse
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Ringden 1987

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment:: unclear; Blinding: none; Excluded:none
Participants	54 patients who had allogenetic myeloablative bone marrow transplantation; Multi center; 5 centers Scandinavia Europe; Setting: hospitalization in isolation precautions and then outpatients
Interventions	CMV hyperimmune plasma vs control. The trial included 2 arms: CMV hyperimmune plasma 30 ml/kg and control; Schedule: 4 times 2 days period (each period total 30 ml/kg): days 3 & 4; days 25 & 26; days 50 & 51; days 75 & 76
Outcomes	All cause mortality; CMV infection; CMV disease; IRM; acute GVHD; chronic GVHD; IP; immunoglobulin levels; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Ruutu 1997

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: none
Participants	28 patients who had myeloablative allogeneic bone marrow transplantation from HLA identical sibling or unrelated donors; Multi‐center ‐ number not mentioned; Scandinavia, Europe Setting: not specified
Interventions	Anti‐CMV hyperimmune globulin vs control. The trial included 2 arms: anti‐CMV hyperimmune globulin 400 mg/kg and control Schedule: 0.4g/kg on day ‐8, then 0.2g/kg on day ‐1,+7,+14,+21,+28,+35,+42,+56,+70
Outcomes	All cause mortality; CMV infections; CMV disease; acute GVHD; chronic GVHD; IP
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Salmon 1967

*Study characteristics*
Methods	Randomization generation: adequate‐randomized card selection; Allocation concealment: unclear; Blinding: double blind Excluded: 7 pts
Participants	48 patients with active multiple myeloma; multi‐center‐ 5 centers; USA (ECOG); Setting: outpatients
Interventions	Cohn fraction II gamma globulin IM vs placebo. The trial included 2 arms: 20 ml of Cohn fraction II gamma globulin 16.5% and 10 ml of Human serum albumin 5% Schedule: every 2 weeks for at least 6 weeks
Outcomes	All cause mortality; CDI; bacterial infections; IRM; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Serrano 1999

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded:none
Participants	92 patients who had myeloablative allogeneic bone marrow transplantation from HLA identical sibling donors; single center, Spain, Europe; Setting: hospitalization in isolation precautions and then outpatients
Interventions	Hyperimmune CMV IVIG vs control. The trial included 2 arms: Hyperimmune CMV IVIG at a dose of 150 mg/kg and control. Schedule: every 2 weeks from day 2 to day +86, then monthly till 1 yr post BMT
Outcomes	All cause mortality; CDI; bacterial infections; fungal infections; bacteremia; CMV infection; CMV disease; IRM; acute GVHD; chronic GVHD; IP; engraftment; relapse; immunoglobulin levels
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Sklenar 1993

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: only patient blinded Excluded: none
Participants	62 CLL and multiple myeloma patients; Multi‐center ‐ 10 centers, USA and Europe; Setting: Outpatients
Interventions	IV polyvalent Immunoglobulin in 3 doses. The trial included 3 arms: (100 mg/kg; 400 mg/kg; 800 mg/kg ) Schedule: every 3 weeks total 6 doses (week 0, 3, 6, 9, 12, 15)
Outcomes	All cause mortality; immunoglobulin levels; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Sullivan 1990

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: 14 pts.
Participants	383 patients who had myeloablative allogeneic BMT or autologous BMT or syngeneic BMT for SAA or acute leukemia or CML or lymphoma; single center ‐ USA; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IV polyvalent Immunoglobulin (Gamimune N) vs control. The trial included 2 arms: IVIG 500 mg/kg and control; Schedule: 15 weekly infusions from day ‐7 to day +90
Outcomes	All cause mortality; CDI; MDI; bacterial infections; fungal infections; viral infections; bacteremia; acute GVHD; IP; relapse; immunoglobulin levels; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Sullivan 2000

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: double blind; Excluded: none
Participants	497 patients who had myeloablative allogeneic BMT from unrelated donor; Multi‐center‐ USA and Europe; Setting: hospitalization in isolation precautions and then outpatients
Interventions	IV polyvalent immunoglobulin (Gammagard) vs. placebo. The trial included 2 arms: IVIG 500 mg/kg and placebo; Schedule: day ‐7 and ‐1 and then weekly from day +6 to day +90
Outcomes	All cause mortality; TRM; relapse
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Ustun 1998

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none; Excluded: none
Participants	14 patients who had alloSCT from HLA identical siblings for acute leukemia, CML, MDS; single center‐ Turkey, Europe; Setting: not mentioned
Interventions	IV polyvalent Immunoglobulin vs control. The trial included 2 arms: IVIG 0.5 g/kg and control; Schedule: day ‐4 then weekly until ANC>0.5 x10(9)/l
Outcomes	All cause mortality; CDI; acute GVHD; VOD; engraftment;
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Winston 1982

*Study characteristics*
Methods	Randomization generation:not specified; Allocation concealment: unclear; Blinding: none Excluded: 6 pts
Participants	54 patients who had myeloablative allogeneic bone marrow transplantation from HLA identical sibling donors; single center; USA Setting: hospitalization in isolation precautions and then outpatients
Interventions	Anti‐CMV hyperimmune plasma at a dose of 10 ml/kg vs. control; Schedule: before conditioning, then on day +3; +30; +45; +60; +75; +90; +120
Outcomes	All cause mortality; CMV infection; CMV disease; IRM; TRM; acute GVHD; IP; relapse; adverse events
Notes	Excluded patients died (ITT)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Winston 1984

*Study characteristics*
Methods	Randomization generation: not specified; Allocation concealment: unclear; Blinding: none Excluded: 5 pts.
Participants	41 patients who had myeloablative allogeneic BMT for acute leukemia in remission or relapse and aplastic anemia from HLA identical sibling donors; Single‐center, USA; setting: hospitalization in isolation precautions and then outpatients
Interventions	IV polyvalent Immunoglobulin 5% in 10% maltose vs control. The trial included 2 arms: IVIG 5% in 10% maltose 20 cc/kg and control; Schedule: before initiation of conditioning and then every week until day +120
Outcomes	All cause mortality; viral infections; CMV infections; CMV disease; acute GVHD; IP; adverse events
Notes	Results from an ongoing study
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Winston 1987

*Study characteristics*
Methods	Randomization generation: not specified; allocation concealment: unclear; Blinding: none Excluded: 14 pts.
Participants	89 patients who had alloBMT T‐ cell depleted from sibling for acute leukemia in remission or relapse and for aplastic anemia; Single‐center, USA; setting: hospitalization in isolation precautions and then outpatients
Interventions	IV polyvalent Immunoglobulinvs control. The trial included 2 arms: IVIG 20 cc/kg and control; Schedule: before initiation of conditioning and then every week until day +120
Outcomes	all cause mortality; CMV infection; CMV disease; acute GVHD; IP; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Winston 1993

*Study characteristics*
Methods	Randomization generation: not specified; allocation concealment: unclear; Blinding: none Excluded: none
Participants	51 patients who had myeloablative allogeneic BMT for acute leukemia nd aplastic anemia and CML and MDS from HLA sibling or unrelated donors; Single‐center, USA; setting: hospitalization in isolation precautions and then outpatients
Interventions	IV polyvalent ImmunoglobulinI(Sandoglobulin) vs control. The trial included 2 arms: IVIG 1 g/kg and control; Schedule: before initiation of conditioning and then every week until day +120
Outcomes	all cause mortality ; bacterial infections; fungal infections; viral infections; bacteremia; CMV infections; CMV disease; IRM; acute GVHD; IP; relapse; adverse events
Notes	in both arms seronegative blood products were administered
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Winston 2001

*Study characteristics*
Methods	Randomization generation: not specified; allocation concealment: unclear; Blinding: double blind Excluded: 9 pts.
Participants	627 patients with acute leukemia, CML, lymphoma, aplastic anemia who had myeloablative allogeneic bone marrow transplantation from sibling or matched unrelated donors; Multi‐center ‐ 13 centers; USA Setting: not specified
Interventions	IV polyvalent Immunoglobulin in 3 doses. The trial included 3 arms: 100 mg/kg; 250 mg/kg; 500 mg/kg Schedule: day ‐2, then weekly from day 0 to day +90, then monthly from day +90 to day +360
Outcomes	all cause mortality; CDI; MDI; bacterial infections; fungal infections; viral infections; bacteremia; CMV infection; CMV disease; IRM; TRM; acute GVHD; chronic GVHD; VOD; IP; relapse; adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Wolff 1993

*Study characteristics*
Methods	Randomization generation:computer generated; allocation concealment: unclear‐ computer generated scheme at each study center; Blinding: none; Excluded:none
Participants	170 patients who had myeloablative autologous BMT or myelosuppressive Rx. for acute leukemia or other disease; Multi‐center ‐ 3 centers; USA; setting: hospitalization in isolation precautions
Interventions	IV polyvalent immunoglobulin (Sandoglobulin) vs. control. The trial included 2 arms: IIVIG Sandoglobulin 500 mg/kg and control; Schedule: weekly dose beginning at start of chemotherapy and discontinued when severe side effects occurred or when neutropenia resolved (>500 PMNs)
Outcomes	all cause mortality; CDI; fungal infections; bacteremia; IRM; TRM; VOD; IP; adverse event
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Zikos 1998

*Study characteristics*
Methods	Randomization generation: not specified; allocation concealment: unclear; Blinding: none; Excluded:none
Participants	128 patients who had myeloablative allogeneic BMT + peripheral stem cell transplant from from HLA identical sibling donor for acute leukemia or CML or SAA and others; single ‐ center ‐ Italy, Europe Setting: hospitalization in isolation precautions and then outpatients
Interventions	anti‐CMV hyperimmune globulin ( CMV IgG) vs. polyvalent Immunoglobulin. The trial included arms: anti‐CMV hyperimmune globulin 100mg/kg (CMV IgG) and polyvalent Immunoglobulin (IVIG) 400 mg/kg Schedule: weekly from day ‐7 to day +100d
Outcomes	all cause mortality; CDI; fungal infections; CMV infections; CMV disease; IRM; TRM; acute GVHD; chronic GVHD; IP;
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

CDI=clinically documented infections; MDI=microbiologically documented infections (all pathogens included, ie bacterial, fungal, viral, other); IRM=infection related mortality; TRM=transplant related mortality; GVHD=graft versus host disease; VOD=veno‐occlusive disease; IP=interstitial pneumonia

Characteristics of excluded studies [ordered by study ID]

Ir a:

estudios incluidos

Study	Reason for exclusion
Aulitzky 1991	Phase I study. The safety and pharmacokinetics of two neutralizing human IgG1 monoclonal antibodies to CMV in BMT recipients was assessed in an open phase I trial.
Bode 1986	Children with leukemia (ALL) and solid tumors reported together as a single cohort (not CLL or MM or BMT)
Bunch 1988	Reports the study by the cooperative CLL group
Chapel 1992	Not an RCT. The study describes the kinetics of immunoglobulin levels in 15 patients given IVIG in a different RCT included in this review (see reference Co‐operative group for the study of CLL)
Chapel 1993	Review
Collins 1991	Reports a study of immunoglobulin prophylaxis in patients with acute leukemia (not CLL or MM or BMT)
Copelan 1994	Oral and not parenteral immunoglobulins. This is a controlled trial of orally administered immunoglobulin following bone marrow transplantation where 72 patients were randomized to oral Ig vs. placebo
Cortez 2002	Not an RCT. Also the intervention was the administration of RSV (respiratory syncitial virus) immunoglobulins and not polyvalent IG or anti CMV IG
Eijkhout 2001	This is a crossover study dealing with 43 patients with primary hypogammaglobulinemia who received standard‐dose immunoglobulin therapy for 9 months, followed by a 3‐month washout period, and high‐dose intravenous immunoglobulin therapy for 9 months, or vice versa.
Elfenbein 1989	Not an RCT
Esperou 2004	This is a subcategory of Cordonnier 2003 dealing with costs only
Fehir 1989	Not RCT. This is a publication reporting on Immune globulin (GAMMAGARD) prophylaxis of CMV infections in patients undergoing organ transplantation and allogeneic bone marrow transplantation
Gamm 1994	The study itself is not an RCT and quotes the RCT by Chapel 1994 (which is already included in the review)
Gerein 1989	All pts. received first hyperimmune CMVIG and only those who became negative were randomized
Gimesi 1992	Reports a study of immunoglobulin prophylaxis in children with acute lymphoblastic leukemia (not CLL or MM or BMT)
Graham Pole 1988	Not an RCT
Jurlander 1994	No RCT. 15 patients with CLL and hypogammaglobulinaemia and a history of recurrent infections received a fixed dose of 10 grams of gammaglobulin intravenously every 3 weeks.
Klaesson 1995	Not RCT. Forty‐five recipients of bone marrow from HLA‐identical siblings were given intravenous immune globulin once a week during the first 3 months after transplantation. Fifty‐three consecutive previously transplanted HLA‐identical siblings were included as controls.
Messori 1994	Not RCT, meta‐analysis. This is an analysis of the RCT's published on the effectiveness of hyperimmune immunoglobulins for prevention of CMV infection or disease in CMV‐seronegative recipients of allogeneic bone marrow transplantation (BMT). The clinical trials were identified by searching a number of computerized literature databases, by reviewing bibliographies of the paper examined and by consulting experts.
Nasman Bjork 1999	Retrospective study. Sera obtained from 13 IVIG‐treated and 31 non‐IVIG‐treated patients before and at different time points after BMT, ranging from 3 days to 3 years, and from 18 healthy controls, were analyzed using a quantitative immunoblot system.
Nurnberger 1988	Not an RCT
Petersen 1987	This report represents a retrospective analysis of bacterial and fungal bacteremia of the same patients from another RCT (see reference Meyers in included studies)
Rand 1991	No RCT. The pharmacokinetics of an IVIG, Gammagard were measured in 31 CMV antibody negative BMT patients as part of a multicenter efficacy trial of 2 weekly dose regimens.
Spitzer 1992	Not an RCT. Historical controls. Continuous infusion intravenous immunoglobulin was compared to intermittent infusion following bone marrow transplantation
Sullivan 1996	includes 383 pts. from Sullivan 1990 & 94 pts. from Bowden 1986. Outcomes reported only for 100 pts
Sullivan 1998	Retrospective analysis. A retrospective analysis of two randomized clinical trials conducted Iin one center to determine the effect of IVIg infusions on the development and severity of VOD. Patients were randomized to receive or not to receive IVIG prophylaxis after allogeneic BMT. To determine the relationship of IVIG to the development and severity of VOD, a single observer reviewed data displays created for each patient for grading VOD without knowledge of patient IVIG use.
Terada 1980	Not an RCT
Vu Van 1985	Not an RCT, a description of 2 pilot studies compared to a historical control

Data and analyses

Open in table viewer

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]
Open in figure viewer Analysis 1.1 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 1: All‐cause Mortality
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]
Open in figure viewer Analysis 1.2 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 2: All cause mortality 100 days
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]
Open in figure viewer Analysis 1.3 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 3: All‐cause Mortality at 1‐2years and more
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]
Open in figure viewer Analysis 1.4 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 4: All‐cause Mortality ‐ by type of HSCT
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]
Open in figure viewer Analysis 1.5 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 5: All cause mortality ‐by use of antifungal prophylaxis
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]
Open in figure viewer Analysis 1.6 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 6: All‐cause Mortality ‐ high dose IVIG
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]
Open in figure viewer Analysis 1.7 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 7: All‐cause Mortality ‐sensitivity analysis by randomization generation
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]
Open in figure viewer Analysis 1.8 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 8: All‐cause Mortality ‐sensitivity analysis by double blinding
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]
Open in figure viewer Analysis 1.9 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 9: Clinically documented infections
1.10 Microbiologically documented infections ‐ bacterial Show forest plot	7	1186	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.88, 1.15]
Open in figure viewer Analysis 1.10 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 10: Microbiologically documented infections ‐ bacterial
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]
Open in figure viewer Analysis 1.11 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 11: Microbiologically documented infections ‐ patient months
1.12 CMV infections Show forest plot	6	986	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.66, 1.07]
Open in figure viewer Analysis 1.12 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 12: CMV infections
1.13 CMV infections ‐ patient months Show forest plot	4	2082	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.49, 1.02]
Open in figure viewer Analysis 1.13 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 13: CMV infections ‐ patient months
1.14 Interstitial Pneumonitis Show forest plot	7	990	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.45, 0.89]
Open in figure viewer Analysis 1.14 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 14: Interstitial Pneumonitis
1.15 Infection‐related Mortality Show forest plot	3	275	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.28, 1.49]
Open in figure viewer Analysis 1.15 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 15: Infection‐related Mortality
1.16 Acute GVHD Show forest plot	7	989	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.04]
Open in figure viewer Analysis 1.16 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 16: Acute GVHD
1.17 VOD Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	2.73 [1.11, 6.71]
Open in figure viewer Analysis 1.17 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 17: VOD
1.18 Adverse Events Show forest plot	5	728	Risk Ratio (M‐H, Fixed, 95% CI)	8.12 [3.15, 20.97]
Open in figure viewer Analysis 1.18 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 18: Adverse Events
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]
Open in figure viewer Analysis 1.19 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 19: VOD according to type of transplant
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
Open in figure viewer Analysis 1.20 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 20: CMV Infections and Interstitial pneumonitis
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
Open in figure viewer Analysis 1.21 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 21: acute GVHD and VOD
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
Open in figure viewer Analysis 1.22 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 22: All‐cause Mortality ‐sensitivity analysis by ITT
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
Open in figure viewer Analysis 1.23 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 23: CMV Infections, Interstitial pneumonitis and VOD
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
Open in figure viewer Analysis 1.24 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 24: Clinically Documented Infections‐ sensitivity analysis by randomization generation
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
Open in figure viewer Analysis 1.25 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 25: Clinically documented infections ‐ sensitivity analysis by blinding
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]
Open in figure viewer Analysis 1.26 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 26: VOD ‐ sensitivity analysis according to randomization generation
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]
Open in figure viewer Analysis 1.27 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 27: VOD ‐ sensitivity analysis by blinding
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]
Open in figure viewer Analysis 1.28 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 28: IP ‐ sensitivity analysis by randomization generation
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]
Open in figure viewer Analysis 1.29 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 29: IP ‐ sensitivity analysis by blinding
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]
Open in figure viewer Analysis 1.30 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 30: Fungal Infections
1.31 Bacteremia Show forest plot	4	653	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.93, 1.13]
Open in figure viewer Analysis 1.31 Comparison 1: Polyvalent immunoglobulins vs. placebo / no intervention ‐ HSCT, Outcome 31: Bacteremia

Open in table viewer

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]
Open in figure viewer Analysis 2.1 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 1: All‐cause Mortality
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]
Open in figure viewer Analysis 2.2 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 2: All‐cause Mortality ‐ 100d (3‐4mo)
2.3 CMV infection Show forest plot	8	553	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.82, 1.26]
Open in figure viewer Analysis 2.3 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 3: CMV infection
2.4 Interstitial Pneumonitis Show forest plot	5	345	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.58, 1.56]
Open in figure viewer Analysis 2.4 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 4: Interstitial Pneumonitis
2.5 Infection‐related Mortality Show forest plot	3	234	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.34, 1.32]
Open in figure viewer Analysis 2.5 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 5: Infection‐related Mortality
2.6 Acute GVHD Show forest plot	5	342	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.72, 1.44]
Open in figure viewer Analysis 2.6 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 6: Acute GVHD
2.7 Adverse Events Show forest plot	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	7.00 [0.38, 129.34]
Open in figure viewer Analysis 2.7 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 7: Adverse Events
2.8 Fungal Infections Show forest plot	2	271	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.54, 1.93]
Open in figure viewer Analysis 2.8 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 8: Fungal Infections
2.9 Bacteremia Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	1.76 [1.23, 2.52]
Open in figure viewer Analysis 2.9 Comparison 2: Hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 9: Bacteremia

Open in table viewer

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]
Open in figure viewer Analysis 3.1 Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 1: All‐cause Mortality
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]
Open in figure viewer 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)
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]
Open in figure viewer Analysis 3.3 Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 3: CMV infection
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]
Open in figure viewer Analysis 3.4 Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 4: Interstitial Pneumonitis
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]
Open in figure viewer Analysis 3.5 Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 5: Infection‐related Mortality
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]
Open in figure viewer Analysis 3.6 Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 6: Acute GVHD
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]
Open in figure viewer Analysis 3.7 Comparison 3: Polyvalent immunoglobulins or hyperimmune CMV‐IVIG vs. placebo / no intervention ‐ HSCT, Outcome 7: Adverse Events
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]

Open in table viewer

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]
Open in figure viewer Analysis 4.1 Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 1: All‐cause Mortality
4.2 Clinically documented Infection Show forest plot	1	128	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [0.89, 2.79]
Open in figure viewer Analysis 4.2 Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 2: Clinically documented Infection
4.3 CMV Infection Show forest plot	3	212	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [1.07, 1.89]
Open in figure viewer Analysis 4.3 Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 3: CMV Infection
4.4 Interstitial Pneumonitis Show forest plot	2	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.40, 1.75]
Open in figure viewer Analysis 4.4 Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 4: Interstitial Pneumonitis
4.5 Infection‐related Mortality Show forest plot	2	177	Risk Ratio (M‐H, Fixed, 95% CI)	3.28 [0.95, 11.26]
Open in figure viewer Analysis 4.5 Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 5: Infection‐related Mortality
4.6 Acute GVHD Show forest plot	2	163	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.87, 1.75]
Open in figure viewer Analysis 4.6 Comparison 4: Polyvalent immunoglobulins vs. hyperimmune CMV‐IVIG ‐ HSCT, Outcome 6: Acute GVHD

Open in table viewer

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]
Open in figure viewer Analysis 5.1 Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 1: All‐cause Mortality
5.2 Clinically documented Infection Show forest plot	2	509	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.81, 0.97]
Open in figure viewer Analysis 5.2 Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 2: Clinically documented Infection
5.3 Microbiologically documented Infection Show forest plot	2	509	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [1.04, 1.57]
Open in figure viewer Analysis 5.3 Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 3: Microbiologically documented Infection
5.4 CMV Infection Show forest plot	1	412	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.34, 1.41]
Open in figure viewer Analysis 5.4 Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 4: CMV Infection
5.5 Interstitial Pneumonitis Show forest plot	2	509	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.33, 2.92]
Open in figure viewer Analysis 5.5 Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 5: Interstitial Pneumonitis
5.6 Infection related Mortality Show forest plot	1	412	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.47, 1.43]
Open in figure viewer Analysis 5.6 Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 6: Infection related Mortality
5.7 Acute GVHD Show forest plot	3	841	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [1.13, 1.55]
Open in figure viewer Analysis 5.7 Comparison 5: Polyvalent immunoglobulins 250mg/kg vs. Polyvalent immunoglobulins or hyperimmune CMV‐IVIG 500mg/kg ‐ HSCT, Outcome 7: Acute GVHD

Open in table viewer

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]
Open in figure viewer Analysis 6.1 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 1: All‐cause Mortality
6.2 Clinically‐documented infections Show forest plot	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.39, 0.61]
Open in figure viewer Analysis 6.2 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 2: Clinically‐documented infections
6.3 Microbiologically‐documented infections Show forest plot	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.53, 0.95]
Open in figure viewer Analysis 6.3 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 3: Microbiologically‐documented infections
6.4 Bacteremia Show forest plot	2	124	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.14, 3.07]
Open in figure viewer Analysis 6.4 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 4: Bacteremia
6.5 Infection‐related Mortality Show forest plot	1	82	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.95]
Open in figure viewer Analysis 6.5 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 5: Infection‐related Mortality
6.6 Adverse Events Show forest plot	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	2.37 [1.74, 3.24]
Open in figure viewer Analysis 6.6 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 6: Adverse Events
6.7 Adverse Events requiring discontinuation Show forest plot	3	205	Risk Ratio (M‐H, Fixed, 95% CI)	5.43 [0.70, 42.24]
Open in figure viewer Analysis 6.7 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 7: Adverse Events requiring discontinuation
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]
Open in figure viewer Analysis 6.8 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 8: Clinically and microbiologically documented infections
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]
Open in figure viewer Analysis 6.9 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 9: Fungal infections
6.10 Bacteremia Show forest plot	1	82	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.68]
Open in figure viewer Analysis 6.10 Comparison 6: Polyvalent immunoglobulins vs. placebo / no intervention ‐ MM/CLL, Outcome 10: Bacteremia

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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Referencias

Referencias de los estudios incluidos en esta revisión

Abdel‐Mageed 1999 {published data only}

Boeckh 2001 {published data only}

Bordigoni 1987 {published data only}

Boughton 1995 {published data only}

Bowden 1986 {published data only}

Bowden 1991 {published data only}

Chapel 1994 {published data only}

Chapel 1994c {published data only}

Condie 1984 {published data only}

Cooperative CLL 1988 {published data only}

Cordonnier 2003 {published data only}

Emanuel 1992 {published data only}

Feinstein 1999 {published data only}

Filipovich 1992 {published data only}

Gluck 1990 {published data only}

Graham Pole 1990 {published data only}

Hargreaves 1992 {published data only}

Jacobsen 1985 {published data only}

Lum 1994 {published data only}

Meyers 1983 {published data only}

Molica 1996 {published data only}

Musto 1995 {published data only}

Peltier 1992 {published data only}

Poynton 1992 {published data only}

Raiola 2002 {published data only}

Ringden 1987 {published data only}

Ruutu 1997 {published data only}

Salmon 1967 {published data only}

Serrano 1999 {published data only}

Sklenar 1993 {published data only}

Sullivan 1990 {published data only}

Sullivan 2000 {published data only}

Ustun 1998 {published data only}

Winston 1982 {published data only}

Winston 1984 {published data only}

Winston 1987 {published data only}

Winston 1993 {published data only}

Winston 2001 {published data only}

Wolff 1993 {published data only}

Zikos 1998 {published data only}

Referencias de los estudios excluidos de esta revisión

Aulitzky 1991 {published data only}

Bode 1986 {published data only}

Bunch 1988 {published data only}

Chapel 1992 {published data only}

Chapel 1993 {published data only}

Collins 1991 {published data only}

Copelan 1994 {published data only}

Cortez 2002 {published data only}

Eijkhout 2001 {published data only}

Elfenbein 1989 {published data only}

Esperou 2004 {published data only}

Fehir 1989 {published data only}

Gamm 1994 {published data only}

Gerein 1989 {published data only}

Gimesi 1992 {published data only}

Graham Pole 1988 {published data only}

Jurlander 1994 {published data only}

Klaesson 1995 {published data only}

Messori 1994 {published data only}

Nasman Bjork 1999 {published data only}

Nurnberger 1988 {published data only}

Petersen 1987 {published data only}

Rand 1991 {published data only}

Spitzer 1992 {published data only}

Sullivan 1996 {published data only}

Sullivan 1998 {published data only}

Terada 1980 {published data only}

Vu Van 1985 {published data only}

Referencias adicionales

Bass 1993

Besa 1992

Chapel 1994a

Chapel 1994b

Consensus IVIG 1990

Espersen 1984