Table 3.
First onset of TEAEs (≥3.0% for any group) by time interval
| Time interval (days) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ≥1 to <7 (n = 647) | ≥7 to <14 (n = 645) | ≥14 to <28 (n = 642) | ≥28 to <56 (n = 628) | ≥56 to <84 (n = 598) | ≥84 to <112 (n = 579) | ≥112 to <196 (n = 561) | ≥196 to <280 (n = 538) | ≥280 to <365 (n = 517) | ≥365 (n = 129) | |
| Overall TEAEs, n (%) | 96 (14.8) | 38 (5.9) | 51 (7.9) | 107 (17.0) | 57 (9.5) | 33 (5.7) | 63 (11.2) | 46 (8.6) | 25 (4.8) | 3 (2.3) |
| Dry mouth | 70 (10.8) | 14 (2.2) | 9 (1.4) | 30 (4.8) | 17 (2.8) | 9 (1.6) | 7 (1.2) | 6 (1.1) | 1 (0.2) | 0 |
| Nasopharyngitis | 1 (0.2) | 4 (0.6) | 11 (1.7) | 17 (2.7) | 14 (2.3) | 6 (1.0) | 24 (4.3) | 37 (6.9) | 26 (5.0) | 0 |
| Constipation | 13 (2.0) | 13 (2.0) | 17 (2.6) | 20 (3.2) | 17 (2.8) | 8 (1.4) | 13 (2.3) | 4 (0.7) | 2 (0.4) | 0 |
| Cystitis | 1 (0.2) | 0 | 3 (0.5) | 4 (0.6) | 10 (1.7) | 5 (0.9) | 17 (3.0) | 17 (3.2) | 8 (1.5) | 1 (0.8) |
| Dysuria | 6 (0.9) | 2 (0.3) | 2 (0.3) | 4 (0.6) | 4 (0.7) | 1 (0.2) | 2 (0.4) | 1 (0.2) | 0 | 0 |
| Back pain | 0 | 0 | 0 | 1 (0.2) | 2 (0.3) | 1 (0.2) | 6 (1.1) | 5 (0.9) | 3 (0.6) | 0 |
| Contusion | 0 | 0 | 2 (0.3) | 3 (0.5) | 2 (0.3) | 0 | 3 (0.5) | 5 (0.9) | 3 (0.6) | 0 |
| Abdominal discomfort | 1 (0.2) | 3 (0.5) | 0 | 1 (0.2) | 3 (0.5) | 1 (0.2) | 4 (0.7) | 2 (0.4) | 2 (0.4) | 0 |
| Eczema | 2 (0.3) | 0 | 0 | 4 (0.6) | 1 (0.2) | 1 (0.2) | 4 (0.7) | 3 (0.6) | 2 (0.4) | 0 |
| Gastroesophageal reflux disease | 2 (0.3) | 1 (0.2) | 0 | 0 | 2 (0.3) | 1 (0.2) | 2 (0.4) | 7 (1.3) | 2 (0.4) | 0 |
| Residual urine volume increased | 1 (0.2) | 0 | 3 (0.5) | 10 (1.6) | 2 (0.3) | 0 | 1 (0.2) | 0 | 0 | 0 |
| Pharyngitis | 1 (0.2) | 0 | 2 (0.3) | 0 | 2 (0.3) | 1 (0.2) | 3 (0.5) | 4 (0.7) | 3 (0.6) | 0 |
| Dermatitis contact | 0 | 0 | 0 | 2 (0.3) | 1 (0.2) | 1 (0.2) | 5 (0.9) | 5 (0.9) | 0 | 0 |
| Gastroenteritis | 1 (0.2) | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 | 4 (0.7) | 3 (0.6) | 2 (0.4) | 0 |
| Osteoarthritis | 0 | 0 | 1 (0.2) | 1 (0.2) | 0 | 0 | 5 (0.9) | 2 (0.4) | 3 (0.6) | 0 |
| Gastritis | 0 | 0 | 0 | 2 (0.3) | 0 | 1 (0.2) | 3 (0.5) | 3 (0.6) | 2 (0.4) | 0 |
| Headache | 3 (0.5) | 0 | 1 (0.2) | 1 (0.2) | 2 (0.3) | 2 (0.3) | 1 (0.2) | 0 | 1 (0.2) | 0 |
| Vomiting | 0 | 1 (0.2) | 1 (0.2) | 0 | 2 (0.3) | 4 (0.7) | 3 (0.5) | 0 | 0 | 0 |
| Dizziness | 1 (0.2) | 0 | 0 | 1 (0.2) | 1 (0.2) | 1 (0.2) | 3 (0.5) | 2 (0.4) | 1 (0.2) | 0 |
| Dental caries | 0 | 0 | 0 | 2 (0.3) | 2 (0.3) | 0 | 1 (0.2) | 2 (0.4) | 2 (0.4) | 0 |
| ECG QT prolonged | 0 | 0 | 0 | 4 (0.6) | 1 (0.2) | 1 (0.2) | 3 (0.5) | 0 | 0 | 0 |
| Osteoporosis | 0 | 0 | 1 (0.2) | 0 | 1 (0.2) | 1 (0.2) | 2 (0.4) | 2 (0.4) | 2 (0.4) | 0 |
| Cataract | 0 | 0 | 0 | 1 (0.2) | 0 | 0 | 5 (0.9) | 1 (0.2) | 1 (0.2) | 0 |
| Dyspepsia | 1 (0.2) | 2 (0.3) | 0 | 1 (0.2) | 0 | 0 | 1 (0.2) | 2 (0.4) | 0 | 0 |
Data shown for the SAF (patients who received at least one dose of study drug).