Table 3.
Summary of severity of gastrointestinal treatment-emergent adverse events
| DU 1.5 mg N = 392 |
DU 0.75 mg N = 395 |
All DU N = 787 |
|
|---|---|---|---|
| Patients with ≥ 1 GI TEAE, n (%) | 134 (34.2) | 91 (23.0) | 225 (28.6) |
| Mild | 90 (23.0) | 64 (16.2) | 154 (19.6) |
| Moderate | 29 (7.4) | 16 (4.1) | 45 (5.7) |
| Severe | 3 (0.8) | 0 (0.0) | 3 (0.4) |
| Diarrhea, n (%) | 66 (16.8) | 37 (9.4) | 103 (13.1) |
| Mild | 45 (11.5) | 28 (7.1) | 73 (9.3) |
| Moderate | 16 (4.1) | 6 (1.5) | 22 (2.8) |
| Severe | 1 (0.3) | 0 (0.0) | 1 (0.1) |
| Nausea, n (%) | 38 (9.7) | 14 (3.5) | 52 (6.6) |
| Mild | 28 (7.1) | 10 (2.5) | 38 (4.8) |
| Moderate | 7 (1.8) | 1 (0.3) | 8 (1.0) |
| Severe | 2 (0.5) | 0 (0.0) | 2 (0.3) |
| Abdominal distension, n (%) | 33 (8.4) | 17 (4.3) | 50 (6.4) |
| Mild | 28 (7.1) | 15 (3.8) | 43 (5.5) |
| Moderate | 2 (0.5) | 2 (0.5) | 4 (0.5) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Vomiting, n (%) | 22 (5.6) | 2 (0.5) | 24 (3.0) |
| Mild | 13 (3.3) | 1 (0.3) | 14 (1.8) |
| Moderate | 5 (1.3) | 1 (0.3) | 6 (0.8) |
| Severe | 2 (0.5) | 0 (0.0) | 2 (0.3) |
Table shows the GI TEAEs reported in at least 5% of patients in any treatment group. The denominator for all the percentages is the number of patients in the specified treatment arm
DU dulaglutide, GI gastrointestinal, N total number of patients in specified treatment arm, n number of patients in the specified category in specified treatment arm, TEAE treatment-emergent adverse event