Table 4 Adverse events occurring in ≥ 5% of participants classified by system organ class and preferred term
Events/participants (% of participants) | |||
|---|---|---|---|
System organ class and preferred term | Treatment through study exit | Baseline to 4 weeks | 4 to 8 weeks |
Gastrointestinal disorders | |||
Diarrhea | 72/44 (30) | 36/29 (20) | 10/10 (7) |
Abdominal pain | 32/18 (12) | 25/17 (11) | 0 (0) |
Constipation | 22/17 (11) | 15/12 (8) | 1/1 (1) |
Nausea | 15/10 (7) | 7/5 (3) | 0 (0) |
Abdominal distension | 11/9 (6) | 11/9 (6) | 0 (0) |
Flatulence | 9/8 (5) | 9/8 (5) | 0 (0) |
General disorders and administration site conditions | |||
Pyrexia | 11/9 (6) | 8/7 (5) | 0 (0) |
Infections and infestations | |||
Urinary tract infection | 26/20 (13) | 4/4 (3) | 4/4 (3) |
Pneumonia | 10/10 (7) | 0 (0) | 0 (0) |
Sepsis | 10/8 (5) | 0 (0) | 1/1 (1) |
Upper respiratory tract infection | 9/8 (5) | 3/3 (2) | 2/2 (1) |
Nervous system disorders | |||
Headache | 9/9 (6) | 7/7 (5) | 0 (0) |
Psychiatric disorders | |||
Anxiety | 8/8 (5) | 3/3 (2) | 0 (0) |