Table 3.
Overview of adverse events and discontinuations stratified by starting dose and age, in 67 double-blind placebo-controlled trials
| Overall* |
< 65 years |
≥ 65 years |
≥75 years |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 50 mg | 100 mg | PL | 50 mg | 100 mg | PL | 50 mg | 100 mg | PL | 50 mg | 100 mg | PL | |
| Adverse events† | (n = 6207) | (n = 1337) | (n = 6602) | (n = 5003) | (n = 1026) | (n = 5294) | (n = 1203) | (n = 308) | (n = 1303) | (n = 134) | (n = 37) | (n = 128) |
| AE, number of events | ||||||||||||
| All causality | 5539 | 1391 | 3260 | 4395 | 1038 | 2513 | 1144 | 353 | 747 | 123 | 44 | 75 |
| Treatment-related | 3011 | 758 | 849 | 2476 | 607 | 692 | 535 | 151 | 157 | 61 | 21 | 10 |
| AE, number (%) of patients | ||||||||||||
| All causality | 2935 (47.3) | 638 (47.7) | 2061 (31.2) | 2344 (46.9) | 487 (47.5) | 1610 (30.4) | 591 (49.1) | 151 (49.0) | 451 (34.6) | 67 (50.0) | 19 (51.4) | 42 (32.8) |
| Severe | 229 (3.7) | 56 (4.2) | 168 (2.5) | 187 (3.7) | 41 (4.0) | 122 (2.3) | 42 (3.5) | 15 (4.9) | 46 (3.5) | 2 (1.5) | 0 | 6 (4.7) |
| Serious | 106 (1.7) | 19 (1.4) | 90 (1.4) | 78 (1.6) | 14 (1.4) | 60 (1.1) | 28 (2.3) | 5 (1.6) | 30 (2.3) | 4 (3.0) | 1 (2.7) | 5 (3.9) |
| DC | 113 (1.8) | 25 (1.9) | 89 (1.3) | 88 (1.8) | 16 (1.6) | 64 (1.2) | 25 (2.1) | 9 (2.9) | 25 (1.9) | 5 (3.7) | 2 (5.4) | 3 (2.3) |
| Dose reduction or temporary DC | 237 (3.8) | 18 (1.3) | 85 (1.3) | 194 (3.9) | 12 (1.2) | 66 (1.2) | 43 (3.6) | 6 (1.9) | 19 (1.5) | 4 (3.0) | 2 (5.4) | 2 (1.6) |
| Treatment-related | 1840 (29.6) | 422 (31.6) | 616 (9.3) | 1510 (30.2) | 329 (32.1) | 496 (9.4) | 330 (27.4) | 93 (30.2) | 120 (9.2) | 40 (29.9) | 13 (35.1) | 7 (5.5) |
| Severe | 81 (1.3) | 19 (1.4) | 25 (0.4) | 68 (1.4) | 14 (1.4) | 23 (0.4) | 13 (1.1) | 5 (1.6) | 2 (0.2) | 0 | 0 | 0 |
| Serious | 9 (0.1) | 1 (0.1) | 4 (0.1) | 6 (0.1) | 1 (0.1) | 3 (0.1) | 3 (0.2) | 0 | 1 (0.1) | 0 | 0 | 0 |
| DC | 54 (0.9) | 12 (0.9) | 29 (0.4) | 40 (0.8) | 9 (0.9) | 22 (0.4) | 14 (1.2) | 3 (1.0) | 7 (0.5) | 1 (0.7) | 1 (2.7) | 1 (0.8) |
| Dose reduction or temporary DC | 176 (2.8) | 8 (0.6) | 34 (0.5) | 150 (3.0) | 6 (0.6) | 28 (0.5) | 26 (2.2) | 2 (0.6) | 6 (0.5) | 3 (2.2) | 1 (2.7) | 0 |
AE, adverse event; DC, discontinuation; NA, data not available; PL, placebo.
Sum of patient numbers in the ‘< 65 years’ group plus the ‘≥ 65 years group’. do not total the numbers in the ‘All ages’ group because age was missing for one patient (50 mg) and three patients (100 mg).
An event was categorised according to investigator judgment as severe if it interrupted daily activity and required systemic drug therapy or other medical treatment. A serious adverse event was defined as any untoward medical occurrence that resulted in death, was life threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, or resulted in a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Listed are DCs, dose reductions and temporary DCs that were caused by an AE.