Table 2. Adverse Events Through Week 28 in the Safety Populationa.
| Adverse event | No. (%) | Difference (95% CI), %b | |
|---|---|---|---|
| Letermovir (n = 292) | Valganciclovir (n = 297) | ||
| Adverse event summary | |||
| ≥1 adverse event | 271 (92.8) | 276 (92.9) | −0.1 (−4.4 to 4.2) |
| Serious adverse eventsc | 106 (36.3) | 113 (38.0) | −1.7 (−9.5 to 6.1) |
| Drug-related adverse eventsd | 58 (19.9) | 104 (35.0) | −15.2 (−22.2 to −8.0) |
| Serious drug-related adverse eventsc,d | 4 (1.4) | 15 (5.1) | −3.7 (−7.0 to −0.9) |
| Death | 2 (0.7) | 1 (0.3) | 0.3 (−1.3 to 2.2) |
| Discontinued due to adverse events | 12 (4.1) | 40 (13.5) | −9.4 (−14.1 to −4.9) |
| Discontinued due to serious adverse eventsc | 6 (2.1) | 14 (4.7) | −2.7 (−5.9 to 0.3) |
| Discontinued due to drug-related adverse eventsd | 8 (2.7) | 26 (8.8) | −6.0 (−10.1 to −2.4) |
| Discontinued due to serious drug-related adverse eventsc,d | 2 (0.7) | 7 (2.4) | −1.7 (−4.2 to 0.4) |
| Adverse events in ≥10% of participants | |||
| Diarrhea | 92 (31.5) | 85 (28.6) | 2.9 (−4.5 to 10.3) |
| Tremor | 53 (18.2) | 52 (17.5) | 0.6 (−5.6 to 6.9) |
| Urinary tract infection | 41 (14.0) | 42 (14.1) | 0.1 (−5.8 to 5.6) |
| Peripheral edema | 39 (13.4) | 38 (12.8) | 0.6 (−4.9 to 6.1) |
| Hypomagnesemia | 37 (12.7) | 39 (13.1) | −0.5 (−5.9 to 5.0) |
| Leukopenia | 33 (11.3) | 110 (37.0) | −25.7 (−32.3 to −19.1) |
| Hypertension | 33 (11.3) | 36 (12.1) | −0.8 (−6.1 to 4.5) |
| Increased creatinine | 30 (10.3) | 41 (13.8) | −3.5 (−8.9 to 1.8) |
| Hypophosphatemia | 30 (10.3) | 35 (11.8) | −1.5 (−6.7 to 3.6) |
| Hyperkalemia | 27 (9.2) | 32 (10.8) | −1.5 (−6.5 to 3.4) |
| Nausea | 25 (8.6) | 33 (11.1) | −2.5 (−7.5 to 2.3) |
| Fatigue | 18 (6.2) | 32 (10.8) | −4.6 (−9.3 to −0.1) |
| Neutropenia | 8 (2.7) | 49 (16.5) | −13.8 (−18.7 to −9.3) |
a
All adverse events were collected from randomization (day 1) through 14 days after the prophylaxis period or early discontinuation of prophylaxis. Please see eTable 4 and eTable 5 in Supplement 2 for additional details on adverse events.
b
Based on Miettinen and Nurminen method.
c
An adverse event was defined as serious if it resulted in death, was life-threatening, required inpatient hospitalization or prolonged an existing hospitalization, or resulted in persistent or significant disability or incapacity.
d
Considered by the investigator to be related to the drug.