Summary of adverse events
| Study . | Study characteristics . | Serious adverse event incidence . | Most common drug-related adverse events . | |||
|---|---|---|---|---|---|---|
| Experimental intervention . | Control intervention . | Experimental arm . | Control arm . | Experimental arm . | Control arm . | |
| 19 | IV acyclovir | Placebo | Not provided | Not provided | Serum AST > twice normal (60%) | Serum AST > twice normal (50%) |
| 17 | Oral acyclovir | Placebo | Not provided | Not provided | Not provided | Not provided |
| 18 | IV acyclovir | Placebo | Not provided | Not provided | Nausea and vomiting (50%) | Nausea and vomiting (80%) |
| 20 | IV acyclovir | Placebo | Not provided | Not provided | Not provided | Not provided |
| 25 | IV ganciclovir | Placebo | Not provided | Not provided | Neutropenia (30%) | Neutropenia (0%) |
| 26 | IV ganciclovir | Placebo | Not provided | Not provided | Neutropenia requiring treatment interruption (58%) | Neutropenia requiring treatment interruption (28%) |
| 21 | IV acyclovir extended | Oral acyclovir | Not provided | Not provided | Nausea (4%-8%)* | Nausea (4%) |
| IV acyclovir short course | Vomiting (3%) | Vomiting (3%) | ||||
| Renal failure (7%-13%)* | Renal failure (9%) | |||||
| 30 | IV ganciclovir | Placebo | Not provided | Not provided | Neutropenia (25%) | Neutropenia (32%) |
| Any bacterial infection (45%) | Any bacterial infection (40%) | |||||
| Invasive fungal disease (16%) | Invasive fungal disease (6%) | |||||
| 23 | Valacyclovir | Oral acyclovir | Not provided | Not provided | Nausea (24%) | Nausea (21%) |
| Vomiting (22%) | Vomiting (22%) | |||||
| Abdominal pain (19%) | Abdominal pain (16%) | |||||
| Diarrhea (19%) | Diarrhea (21%) | |||||
| 24 | IV ganciclovir | Oral acyclovir | Not provided | Not provided | Secondary neutropenia (62%) | Secondary neutropenia (39%) |
| Renal insufficiency (38%) | Renal insufficiency (33%) | |||||
| 28 | Valacyclovir | IV ganciclovir | Not provided | Not provided | Neutropenia (32%) | Neutropenia (13%) |
| Renal insufficiency (6%) | Renal insufficiency (10%) | |||||
| Nausea, vomiting (5%) | Nausea, vomiting (8%) | |||||
| 27 | IV ganciclovir | Oral ganciclovir | Not provided | Not provided | Not provided | Not provided |
| 22 | Oral acyclovir | Placebo | Not provided | Not provided | Gastrointestinal effects (8%) | Neutropenia (3%) |
| Pancytopenia (3%) | ||||||
| Increased liver function tests (3%) | ||||||
| 29 | Maribavir 100 mg twice daily | Placebo | Not provided | Not provided | Taste disturbance (18%-31%)* | Taste disturbance (0%) |
| Maribavir 400 mg daily | Placebo | Nausea (7%-15%)* | Nausea (0%) | |||
| Maribavir 400 mg twice daily | Placebo | Vomiting (4%-11%)* | Vomiting (4%) | |||
| 34 | Maribavir 100 mg twice daily | Placebo | 197/451 (44%) | 98/223 (44%) | Acute GVHD (36%) | Acute GVHD (33%) |
| Diarrhea (21%) | Diarrhea (19%) | |||||
| Fatigue (16%) | Fatigue (10%) | |||||
| 33 | Brincidofovir 40 mg weekly | Placebo | 12/25 (48%) | 27/59 (46%) | Diarrhea (12%-70%)* | Diarrhea (27%) |
| Brincidofovir 100 mg weekly | Placebo | 10/27 (37%) | Vomiting (8%-44%)* | Abdominal pain (7%) | ||
| Brincidofovir 200 mg weekly | Placebo | 19/39 (49%) | Acute GVHD (32%-80%)* | Acute GVHD (29%) | ||
| Brincidofovir 200 mg biweekly | Placebo | 21/30 (70%) | ||||
| Brincidofovir 100 mg biweekly | Placebo | 30/50 (60%) | ||||
| 35 | Letermovir 60 mg daily | Placebo | 9/33 (27%) | 12/33 (36%) | Gastrointestinal disorders (52%-76%)* | Gastrointestinal disorders (61%) |
| Letermovir 120 mg daily | Placebo | 12/31 (39%) | Infections (52%-59%)* | Infections (76%) | ||
| Letermovir 240 mg daily | Placebo | 9/34 (26%) | Skin and cutaneous tissue disorders (39%-55%)* | Skin and cutaneous tissue disorders (33%) | ||
| 32 | Brincidofovir 100 mg biweekly | Placebo | 173/303 (57%) | 56/149 (38%) | Diarrhea (61%) | Diarrhea (36%) |
| Acute GVHD (57%) | Acute GVHD (32%) | |||||
| Abdominal pain (34%) | Abdominal pain (17%) | |||||
| 31 | Letermovir 480 mg daily | Placebo | 193/373 (52%) | 109/192 (57%) | GVHD (39%) | GVHD (39%) |
| Diarrhea (26%) | Diarrhea (25%) | |||||
| Nausea (27%) | Nausea (23%) | |||||
| Study . | Study characteristics . | Serious adverse event incidence . | Most common drug-related adverse events . | |||
|---|---|---|---|---|---|---|
| Experimental intervention . | Control intervention . | Experimental arm . | Control arm . | Experimental arm . | Control arm . | |
| 19 | IV acyclovir | Placebo | Not provided | Not provided | Serum AST > twice normal (60%) | Serum AST > twice normal (50%) |
| 17 | Oral acyclovir | Placebo | Not provided | Not provided | Not provided | Not provided |
| 18 | IV acyclovir | Placebo | Not provided | Not provided | Nausea and vomiting (50%) | Nausea and vomiting (80%) |
| 20 | IV acyclovir | Placebo | Not provided | Not provided | Not provided | Not provided |
| 25 | IV ganciclovir | Placebo | Not provided | Not provided | Neutropenia (30%) | Neutropenia (0%) |
| 26 | IV ganciclovir | Placebo | Not provided | Not provided | Neutropenia requiring treatment interruption (58%) | Neutropenia requiring treatment interruption (28%) |
| 21 | IV acyclovir extended | Oral acyclovir | Not provided | Not provided | Nausea (4%-8%)* | Nausea (4%) |
| IV acyclovir short course | Vomiting (3%) | Vomiting (3%) | ||||
| Renal failure (7%-13%)* | Renal failure (9%) | |||||
| 30 | IV ganciclovir | Placebo | Not provided | Not provided | Neutropenia (25%) | Neutropenia (32%) |
| Any bacterial infection (45%) | Any bacterial infection (40%) | |||||
| Invasive fungal disease (16%) | Invasive fungal disease (6%) | |||||
| 23 | Valacyclovir | Oral acyclovir | Not provided | Not provided | Nausea (24%) | Nausea (21%) |
| Vomiting (22%) | Vomiting (22%) | |||||
| Abdominal pain (19%) | Abdominal pain (16%) | |||||
| Diarrhea (19%) | Diarrhea (21%) | |||||
| 24 | IV ganciclovir | Oral acyclovir | Not provided | Not provided | Secondary neutropenia (62%) | Secondary neutropenia (39%) |
| Renal insufficiency (38%) | Renal insufficiency (33%) | |||||
| 28 | Valacyclovir | IV ganciclovir | Not provided | Not provided | Neutropenia (32%) | Neutropenia (13%) |
| Renal insufficiency (6%) | Renal insufficiency (10%) | |||||
| Nausea, vomiting (5%) | Nausea, vomiting (8%) | |||||
| 27 | IV ganciclovir | Oral ganciclovir | Not provided | Not provided | Not provided | Not provided |
| 22 | Oral acyclovir | Placebo | Not provided | Not provided | Gastrointestinal effects (8%) | Neutropenia (3%) |
| Pancytopenia (3%) | ||||||
| Increased liver function tests (3%) | ||||||
| 29 | Maribavir 100 mg twice daily | Placebo | Not provided | Not provided | Taste disturbance (18%-31%)* | Taste disturbance (0%) |
| Maribavir 400 mg daily | Placebo | Nausea (7%-15%)* | Nausea (0%) | |||
| Maribavir 400 mg twice daily | Placebo | Vomiting (4%-11%)* | Vomiting (4%) | |||
| 34 | Maribavir 100 mg twice daily | Placebo | 197/451 (44%) | 98/223 (44%) | Acute GVHD (36%) | Acute GVHD (33%) |
| Diarrhea (21%) | Diarrhea (19%) | |||||
| Fatigue (16%) | Fatigue (10%) | |||||
| 33 | Brincidofovir 40 mg weekly | Placebo | 12/25 (48%) | 27/59 (46%) | Diarrhea (12%-70%)* | Diarrhea (27%) |
| Brincidofovir 100 mg weekly | Placebo | 10/27 (37%) | Vomiting (8%-44%)* | Abdominal pain (7%) | ||
| Brincidofovir 200 mg weekly | Placebo | 19/39 (49%) | Acute GVHD (32%-80%)* | Acute GVHD (29%) | ||
| Brincidofovir 200 mg biweekly | Placebo | 21/30 (70%) | ||||
| Brincidofovir 100 mg biweekly | Placebo | 30/50 (60%) | ||||
| 35 | Letermovir 60 mg daily | Placebo | 9/33 (27%) | 12/33 (36%) | Gastrointestinal disorders (52%-76%)* | Gastrointestinal disorders (61%) |
| Letermovir 120 mg daily | Placebo | 12/31 (39%) | Infections (52%-59%)* | Infections (76%) | ||
| Letermovir 240 mg daily | Placebo | 9/34 (26%) | Skin and cutaneous tissue disorders (39%-55%)* | Skin and cutaneous tissue disorders (33%) | ||
| 32 | Brincidofovir 100 mg biweekly | Placebo | 173/303 (57%) | 56/149 (38%) | Diarrhea (61%) | Diarrhea (36%) |
| Acute GVHD (57%) | Acute GVHD (32%) | |||||
| Abdominal pain (34%) | Abdominal pain (17%) | |||||
| 31 | Letermovir 480 mg daily | Placebo | 193/373 (52%) | 109/192 (57%) | GVHD (39%) | GVHD (39%) |
| Diarrhea (26%) | Diarrhea (25%) | |||||
| Nausea (27%) | Nausea (23%) | |||||
AST, aspartate aminotransferase.
Range provided for different treatment arms and dose levels.