MedDRA System Organ Class and Preferred Term | Timing of first event (months) | Adverse event duration, all events (days) | Number and percentage of patients with only one event | |||||
---|---|---|---|---|---|---|---|---|
≤3 months, n/N (% of pts with AE) | Median | Q1, Q3 | 1–14 | > 14 | Median | Q1, Q3 | ||
Gastrointestinal Disorders | ||||||||
Abdominal pain upper | 13/62 (21.0) | 12.8 | 3.8, 23.3 | 50 | 39 | 12.0 | 2.0, 67.0 | 46/62 (74.2) |
Diarrhea | 25/58 (43.1) | 5.5 | 0.6, 21.8 | 56 | 24 | 4.0 | 2.0, 24.0 | 44/58 (75.9) |
Nausea | 22/51 (43.1) | 4.1 | 1.0, 17.6 | 39 | 26 | 8.0 | 2.0, 27.0 | 41/51 (80.4) |
Dyspepsia | 12/45 (26.7) | 10.15 | 2.6, 21.3 | 34 | 34 | 16.5 | 3.0, 280.5 | 32/45 (71.1) |
Abdominal pain | 14/45 (31.1) | 10.7 | 1.5, 20.7 | 31 | 25 | 9.5 | 2.0, 135.5 | 35/45 (77.8) |
Constipation | 14/34 (41.2) | 5.2 | 1.3, 17.9 | 11 | 26 | 126.0 | 11.0, 655.0 | 31/34 (91.2) |
Gastroesophageal reflux disease | 9/29 (31.0) | 6.1 | 2.4, 19.7 | 12 | 25 | 91.0 | 8.0, 233.0 | 24/29 (82.8) |
Abdominal distension | 7/18 (38.9) | 4.7 | 1.5, 19.0 | 7 | 15 | 28.0 | 8.0, 136.0 | 14/18 (77.8) |
Gastritis | 2/16 (12.5) | 25.4 | 7.5, 33.2 | 5 | 15 | 204.5 | 20.0, 411.0 | 13/16 (81.3) |
Musculoskeletal and Connective Tissue Disorders | ||||||||
Arthralgia | 10/103 (9.7) | 13.8 | 6.2, 26.7 | 55 | 145 | 70.5 | 8.0, 305.0 | 57/103 (55.3) |
Nervous System Disorders | ||||||||
Headache | 40/94 (42.6) | 5.5 | 0.6, 20.1 | 164 | 71 | 2.0 | 1.0, 27.0 | 51/94 (54.3) |
Dizziness | 24/57 (42.1) | 5.8 | 0.2, 18.0 | 28 | 39 | 21.0 | 2.0, 112.0 | 50/57 (87.7) |
General Disorders and Administration Site Conditions | ||||||||
Fatigue | 17/50 (34.0) | 5.3 | 1.0, 19.3 | 13 | 56 | 191.0 | 23.0, 484.0 | 36/50 (72.0) |
Cardiac Disorders | ||||||||
Palpitations | 9/27 (33.3) | 6.0 | 1.2, 13.6 | 14 | 18 | 33.0 | 4.0, 95.0 | 23/27 (85.2) |