Table 5.
Frequency of TEAEs by teduglutide treatment duration.
| Preferred term, n (%) | Duration of teduglutide treatment in the RCT/extension teduglutide group, n = 173 |
||||
|---|---|---|---|---|---|
| ⩽12 weeks (n = 17) | >12–24 weeks (n = 10) | >24–48 weeks (n = 30) | >48–96 weeks (n = 49) | >96 weeks (n = 67) | |
| Gastrointestinal disorders | |||||
| Abdominal pain | 9 (52.9) | 4 (40.0) | 10 (33.3) | 12 (24.5) | 19 (28.4) |
| Nausea | 8 (47.1) | 2 (20.0) | 3 (10.0) | 18 (36.7) | 14 (20.9) |
| Abdominal distension | 5 (29.4) | 1 (10.0) | 6 (20.0) | 7 (14.3) | 13 (19.4) |
| Vomiting | 4 (23.5) | 3 (30.0) | 2 (6.7) | 9 (18.4) | 8 (11.9) |
| Diarrhoea | 2 (11.8) | 2 (20.0) | 5 (16.7) | 3 (6.1) | 12 (17.9) |
| Flatulence | 0 | 1 (10.0) | 2 (6.7) | 5 (10.2) | 11 (16.4) |
| Abdominal pain upper | 1 (5.9) | 1 (10.0) | 2 (6.7) | 6 (12.2) | 3 (4.5) |
| Abdominal discomfort | 0 | 3 (30.0) | 3 (10.0) | 2 (4.1) | 3 (4.5) |
| Dyspepsia | 1 (5.9) | 0 | 1 (3.3) | 5 (10.2) | 2 (3.0) |
| Other most common TEAEs† | |||||
| Gastrointestinal stoma complication‡ | 6 (54.5) | 2 (100.0) | 7 (53.8) | 5 (27.8) | 11 (45.8) |
| Headaches | 0 | 3 (30.0) | 6 (20.0) | 16 (32.7) | 8 (11.9) |
| Urinary tract infections | 1 (5.9) | 0 | 4 (13.3) | 10 (20.4) | 13 (19.4) |
| Nasopharyngitis | 1 (5.9) | 1 (10.0) | 4 (13.3) | 12 (24.5) | 9 (13.4) |
| Pyrexia | 0 | 2 (20.0) | 5 (16.7) | 5 (10.2) | 14 (20.9) |
| Weight decreased | 0 | 0 | 2 (6.7) | 3 (6.1) | 20 (29.9) |
| Asthenia | 2 (11.8) | 1 (10.0) | 0 | 6 (12.2) | 12 (17.9) |
| Catheter sepsis | 2 (11.8) | 1 (10.0) | 4 (13.3) | 6 (12.2) | 6 (9.0) |
| Fatigue | 1 (5.9) | 1 (10.0) | 3 (10.0) | 6 (12.2) | 8 (11.9) |
| Peripheral oedema | 3 (17.6) | 0 | 5 (16.7) | 3 (6.1) | 7 (10.4) |
| Dehydration | 1 (5.9) | 1 (10.0) | 1 (3.3) | 3 (6.1) | 11 (16.4) |
| Injection site haematoma | 0 | 2 (20.0) | 0 | 11 (22.4) | 2 (3.0) |
| Muscle spasms | 0 | 0 | 1 (3.3) | 6 (12.2) | 8 (11.9) |
| Arthralgia | 0 | 1 (10.0) | 3 (10.0) | 5 (10.2) | 6 (9.0) |
| Injection site erythema | 0 | 2 (20.0) | 2 (6.7) | 6 (12.2) | 3 (4.5) |
| Back pain | 0 | 0 | 3 (10.0) | 5 (10.2) | 5 (7.5) |
| Decreased appetite | 2 (11.8) | 3 (30.0) | 0 | 5 (10.2) | 2 (3.0) |
| Catheter-related infection | 0 | 0 | 2 (6.7) | 1 (2.0) | 9 (13.4) |
| Pain in extremity | 0 | 0 | 3 (10.0) | 1 (2.0) | 8 (11.9) |
| Influenza | 1 (5.9) | 1 (10.0) | 0 | 6 (12.2) | 3 (4.5) |
| Central line infection | 1 (5.9) | 0 | 0 | 0 | 9 (13.4) |
| Catheter bacteraemia | 0 | 0 | 3 (10.0) | 3 (6.1) | 4 (6.0) |
| Catheter site infection | 0 | 0 | 1 (3.3) | 2 (4.1) | 7 (10.4) |
| Hot flush | 0 | 1 (10.0) | 0 | 2 (4.1) | 6 (9.0) |
| Depression | 0 | 0 | 3 (10.0) | 1 (2.0) | 5 (7.5) |
| Contusion | 0 | 0 | 2 (6.7) | 5 (10.2) | 2 (3.0) |
| Cough | 0 | 0 | 2 (6.7) | 5 (10.2) | 2 (3.0) |
| Dizziness | 0 | 0 | 0 | 5 (10.2) | 4 ( 6.0) |
| Blood bicarbonate decreased | 1 (5.9) | 0 | 1 (3.3) | 1 (2.0) | 6 (9.0) |
AE, adverse event; RCT, randomized controlled trial; TEAE, treatment-emergent AE.
†
Most common TEAEs (by AE preferred term) occurring in at least 5.0% of patients overall in the RCT/extension teduglutide group.
‡
Percentages calculated based on number of patients with a stoma (n = 11 for ⩽12 weeks; n = 2 for >12–24 weeks; n = 13 for >24–48 weeks; n = 18 for >48–96 weeks; n = 24 for >96 weeks).