Table 4 Incidence, severity and relatedness of treatment-emergent adverse events reported at least once as relateda in at least 2% of all patients
MedDRA System Organ Class and Preferred Term | Patients with events n (% overall) (N = 393) | Event relatednessb (by patient) | Events n (/100 patient-years) | Event severity (by event) | Patients with serious event n | Placebo-treated ENGAGE patients with events n (%)c | |||
|---|---|---|---|---|---|---|---|---|---|
No n (% overall) | Yes n (% overall) | Mild n | Moderate n | Severe n | |||||
Gastrointestinal Disorders | |||||||||
Abdominal pain upper | 62 (15.8) | 42 (10.7) | 20 (5.1) | 89 (6) | 70 | 16 | 3 | 0 | 1 (5.0) |
Diarrhea | 58 (14.8) | 40 (10.2) | 18 (4.6) | 80 (6) | 67 | 12 | 1 | 1 | 4 (20.0) |
Nausea | 51 (13.0) | 33 (8.4) | 18 (4.6) | 65 (5) | 48 | 17 | 0 | 0 | 1 (5.0) |
Dyspepsia | 45 (11.5) | 22 (5.6) | 23 (5.9) | 68 (5) | 39 | 25 | 4 | 0 | 0 (0) |
Abdominal pain | 45 (11.5) | 34 (8.7) | 11 (2.8) | 56 (4) | 39 | 16 | 1 | 0 | 2 (10.0) |
Constipation | 34 (8.7) | 21 (5.3) | 13 (3.3) | 37 (3) | 29 | 8 | 0 | 0 | 0 (0) |
Gastroesophageal reflux disease | 29 (7.4) | 18 (4.6) | 11 (2.8) | 37 (3) | 20 | 17 | 0 | 0 | 0 (0) |
Abdominal distension | 18 (4.6) | 8 (2.0) | 10 (2.5) | 22 (2) | 15 | 7 | 0 | 0 | 1 (5.0) |
Gastritis | 16 (4.1) | 7 (1.8) | 9 (2.3) | 20 (1) | 18 | 2 | 0 | 0 | 0 (0) |
Musculoskeletal and Connective Tissue Disorders | |||||||||
Arthralgia | 103 (26.2) | 89 (22.6) | 14 (3.6) | 200 (14) | 130 | 55 | 15 | 2 | 2 (10.0) |
Nervous System Disorders | |||||||||
Headache | 94 (23.9) | 73 (18.6) | 21 (5.3) | 235 (17) | 171 | 53 | 11 | 0 | 6 (30.0) |
Dizziness | 57 (14.5) | 37 (9.4) | 20 (5.1) | 67 (5) | 56 | 9 | 2 | 1 | 2 (10.0) |
General Disorders and Administration Site Conditions | |||||||||
Fatigue | 50 (12.7) | 39 (9.9) | 11 (2.8) | 69 (5) | 49 | 18 | 2 | 0 | 2 (10.0) |
Cardiac Disorders | |||||||||
Palpitations | 27 (6.9) | 16 (4.1) | 11 (2.8) | 32 (2) | 28 | 4 | 0 | 0 | 1 (5.0) |