Onset and duration of AEs
| AE . | Any grade (n) . | Time to onset (mo) . | Duration (mo) . |
|---|---|---|---|
| Blood and lymphatic system disorders | |||
| Anemia* | 40 | 1.9 (0.0, 32.5) | 0.9 (0.0, 12.8) |
| Neutropenia (including febrile neutropenia)† | 53 | 1.9 (0.0, 16.6) | 0.5 (0.0, 11.7) |
| Gastrointestinal disorders | |||
| Colitis (noninfectious)‡ | 9 | 6.0 (2.8, 28.4) | 0.7 (0.2, 3.0) |
| Constipation | 39 | 1.0 (0.0, 37.7) | 1.1 (0.0, 54.2) |
| Diarrhea | 194 | 1.0 (0.0, 22.8) | 0.6 (0.0, 53.7) |
| Hepatobiliary disorders | |||
| Transaminase elevation§ | 63 | 1.9 (0.0, 9.5) | 1.1 (0.0, 17.1) |
| Infections and infestations | |||
| Colitis (infectious)‖‖ | 3 | 1.4 (0.4, 1.6) | 0.4 (0.0, 0.9) |
| Pneumonia¶ | 29 | 3.7 (0.8, 25.2) | 0.5 (0.1, 18.0) |
| AE . | Any grade (n) . | Time to onset (mo) . | Duration (mo) . |
|---|---|---|---|
| Blood and lymphatic system disorders | |||
| Anemia* | 40 | 1.9 (0.0, 32.5) | 0.9 (0.0, 12.8) |
| Neutropenia (including febrile neutropenia)† | 53 | 1.9 (0.0, 16.6) | 0.5 (0.0, 11.7) |
| Gastrointestinal disorders | |||
| Colitis (noninfectious)‡ | 9 | 6.0 (2.8, 28.4) | 0.7 (0.2, 3.0) |
| Constipation | 39 | 1.0 (0.0, 37.7) | 1.1 (0.0, 54.2) |
| Diarrhea | 194 | 1.0 (0.0, 22.8) | 0.6 (0.0, 53.7) |
| Hepatobiliary disorders | |||
| Transaminase elevation§ | 63 | 1.9 (0.0, 9.5) | 1.1 (0.0, 17.1) |
| Infections and infestations | |||
| Colitis (infectious)‖‖ | 3 | 1.4 (0.4, 1.6) | 0.4 (0.0, 0.9) |
| Pneumonia¶ | 29 | 3.7 (0.8, 25.2) | 0.5 (0.1, 18.0) |
Data are expressed as median (minimum, maximum) unless otherwise indicated. Each occurrence of the same AE was counted as an independent AE. In cases in which 2 or more AEs overlapped or continued from one to another, they were combined as 1 AE in duration calculation. If the end date was missing (eg, ongoing AE), it was imputed as the earliest of (safety data cutoff date, last treatment date + 30 days, end-of-study date, death date).
Grouped term for reactions with multiple preferred terms:
Anemia, hemoglobin decreased.
Neutropenia, febrile neutropenia.
Colitis, colitis microscopic.
Alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased, hepatic enzyme increased.
Clostridium difficile colitis and enterocolitis viral.
Lower respiratory tract infection, pneumonia, pneumonia Haemophilus, pneumonia Legionella.