Table 2.
Summary of AEs, regardless of relationship to study drug.
| Total (N = 202) |
|
|---|---|
| Total number of AEs | 174 |
| Patients with ⩾1 AE, n (%)a | 77 (38.1) |
| Not seriousb | 73 (42.0) |
| Seriousb | 8 (4.6) |
| No assessment of seriousness recordedb | 93 (53.4) |
| AEs occurring in ⩾1.5% of patients, n (%)c | |
| Diarrhoead | 54 (26.7) |
| Abdominal pain | 21 (10.4) |
| Abdominal distension | 13 (6.4) |
| Anal incontinence | 8 (4.0) |
| Nausea | 8 (4.0) |
| Defecation urgency | 5 (2.5) |
| Dyspepsia | 5 (2.5) |
| Headache | 5 (2.5) |
| Vomiting | 4 (2.0) |
| Condition aggravated | 3 (1.5) |
| Constipation | 3 (1.5) |
| Gastrointestinal sounds abnormal | 3 (1.5) |
| Malaise | 3 (1.5) |
| Muscle spasms | 3 (1.5) |
a
Includes AEs where the relationship to study drug is related, probable, possible or unknown.
b
Expressed as a proportion of 174 events reported.
c
Expressed as number of events (percentage of patients).
d
Includes events of loose stools coded as diarrhoea.
AE, adverse event.