Table 2.
Treatment-Emergent Adverse Events Occurring in ≥10% of Patients in Either Treatment Group or for Individual Investigator-Assigned Therapy (Safety Population)
| System Organ Class Preferred Term | Maribavir (n = 234) | IAT (n = 116) | IAT Typea | ||
|---|---|---|---|---|---|
| Ganciclovir/Valganciclovir (n = 56) | Foscarnet (n = 47) | Cidofovir (n = 6) | |||
| Any TEAE | 228 (97.4) | 106 (91.4) | 51 (91.1) | 43 (91.5) | 5 (83.3) |
| Blood and lymphatic system disorders | |||||
| Anemia | 29 (12.4) | 14 (12.1) | 4 (7.1) | 9 (19.1) | 0 |
| Leukopenia | 7 (3.0) | 8 (6.9) | 7 (12.5) | 1 (2.1) | 0 |
| Neutropenia | 22 (9.4) | 26 (22.4) | 19 (33.9) | 7 (14.9) | 0 |
| Gastrointestinal disorders | |||||
| Diarrhea | 44 (18.8) | 24 (20.7) | 13 (23.2) | 9 (19.1) | 1 (16.7) |
| Nausea | 50 (21.4) | 25 (21.6) | 8 (14.3) | 14 (29.8) | 1 (16.7) |
| Vomiting | 33 (14.1) | 19 (16.4) | 7 (12.5) | 8 (17.0) | 2 (33.3) |
| General disorders and administration site conditions | |||||
| Fatigue | 28 (12.0) | 10 (8.6) | 7 (12.5) | 3 (6.4) | 0 |
| Edema peripheral | 17 (7.3) | 9 (7.8) | 3 (5.4) | 5 (10.6) | 0 |
| Pyrexia | 24 (10.3) | 17 (14.7) | 6 (10.7) | 9 (19.1) | 2 (33.3) |
| Infections and infestations | |||||
| CMV viremiab | 24 (10.3) | 6 (5.2) | 4 (7.1) | 1 (2.1) | 0 |
| Metabolism and nutrition disorders | |||||
| Hypokalemia | 8 (3.4) | 11 (9.5) | 1 (1.8) | 9 (19.1) | 1 (16.7) |
| Hypomagnesemia | 9 (3.8) | 10 (8.6) | 2 (3.6) | 7 (14.9) | 1 (16.7) |
| Hypophosphatemia | 4 (1.7) | 5 (4.3) | 0 | 5 (10.6) | 0 |
| Nervous system disorders | |||||
| Dysgeusia | 87 (37.2) | 4 (3.4) | 2 (3.6) | 0 | 1 (16.7) |
| Headache | 19 (8.1) | 15 (12.9) | 6 (10.7) | 8 (17.0) | 0 |
| Paresthesia | 4 (1.7) | 5 (4.3) | 0 | 5 (10.6) | 0 |
| Renal and urinary disorders | |||||
| Acute kidney injury | 20 (8.5) | 11 (9.5) | 1 (1.8) | 10 (21.3) | 0 |
| Vascular disorders | |||||
| Hypertension | 9 (3.8) | 8 (6.9) | 1 (1.8) | 6 (12.8) | 0 |
Data are presented as n (%).The cidofovir group was not considered in the application of the 10% cutoff due to low patient numbers (n = 6). The on-treatment observation period started at the time of study-assigned treatment initiation through 7 days after the last dose of study-assigned treatment or through 21 days if cidofovir was used, or until the maribavir rescue treatment initiation or until the nonstudy CMV treatment initiation, whichever was earlier. Adverse events were coded using the Medical Dictionary for Regulatory Activities, version 23.0.
Abbreviations: CMV, cytomegalovirus; IAT, investigator-assigned therapy; TEAE, treatment-emergent adverse event.
Overall, 7 patients received a combination of valganciclovir/ganciclovir and foscarnet (not included in the table).
Events such as worsening of CMV viremia were coded to the preferred term of CMV viremia.