Table 2.
Summary of adverse events for participants on treatment during the controlled assessment period (safety analysis set)*
| Event | Exenatide (N = 59) |
Placebo (N = 23) |
Total (N = 82) |
|---|---|---|---|
| Any AE | 36 (61.0) | 17 (73.9) | 53 (64.6) |
| Any AE with outcome of death | 0 | 0 | 0 |
| Any SAE including those with outcome of death | 2 (3.4) | 1 (4.3) | 3 (3.7) |
| Any AE related to treatment† | 15 (25.4) | 5 (21.7) | 20 (24.4) |
| Gastrointestinal disorders‡ | 13 (22.0) | 6 (26.1) | 19 (23.2) |
| Abdominal distension | 1 (1.7) | 0 | 1 (1.2) |
| Abdominal pain | 2 (3.4) | 3 (13.0) | 5 (6.1) |
| Abdominal pain upper | 3 (5.1) | 0 | 3 (3.7) |
| Diarrhea | 5 (8.5) | 1 (4.3) | 6 (7.3) |
| Dyspepsia | 1 (1.7) | 0 | 1 (1.2) |
| Gastrointestinal pain | 0 | 1 (4.3) | 1 (1.2) |
| Gastroesophageal reflux disease | 0 | 1 (4.3) | 1 (1.2) |
| Gingival pain | 1 (1.7) | 0 | 1 (1.2) |
| Irritable bowel syndrome | 0 | 1 (4.3) | 1 (1.2) |
| Nausea | 4 (6.8) | 1 (4.3) | 5 (6.1) |
| Salivary gland mucocele | 0 | 1 (4.3) | 1 (1.2) |
| Vomiting | 3 (5.1) | 0 | 3 (3.7) |
| Hypoglycemia | 8 (13.6) | 1 (4.3) | 9 (11.0) |
| Major§ | 0 | 0 | 0 |
| Minorǁ | 1 (1.7) | 1 (4.3) | 2 (2.4) |
| Other¶ | 8 (13.6) | 1 (4.3) | 9 (11.0) |
Data are n (%). A controlled assessment period AE was defined as an AE starting on or after the day of the first dose of the study medication up to but not including week 24 for participants entering the extension period. For participants not entering the extension period, the period was defined up to and including the last dose of the study medication +7 days (+90 days for SAEs and other clinically significant or related AEs). Events were captured for the controlled assessment period whose length depended on whether participants entered the extension period as described above. Percentages were calculated from the number of participants in the analysis set for the study period by treatment group and in total. AEs were coded with MedDRA, version 23.0. SAE, serious AE.
Participants with multiple events in the same category were counted only once in that category. Participants with events in more than one category were counted once in each of those categories.
Included causally related AEs as judged by the investigator.
Number (%) of participants were sorted in international order for system organ class and alphabetical order for preferred term.
An event that resulted in loss of consciousness, seizure, or coma (or other mental status changes consistent with neuroglycopenia as judged by an investigator or physician) and that resolved after at least 1 item of intervention recorded in the hypoglycemic event eCRF or an event that required third-party assistance and was associated with a plasma or capillary glucose level of <3 mmol/L (54 mg/dL).
Nonmajor hypoglycemia event with symptoms consistent with hypoglycemia and a glucose level of <3 mmol/L (54 mg/dL) prior to treating the episode.
Hypoglycemia events that did not meet the criteria for a major or minor event.