Table 3.
Adverse Events Occurring in at Least 5% of Participants
| No. (%) of Participants |
|||
|---|---|---|---|
| Placebo (n = 821)a | Tarenflurbil (n = 860)a | P Valueb | |
| Adverse events | |||
| ≥1 Event | 698 (85.0) | 750 (87.2) | .19 |
|
| |||
| Discontinued | 95 (11.6) | 158 (18.4) | <.001 |
|
| |||
| ≥1 Serious | 163 (19.9) | 195 (22.7) | .16 |
|
| |||
| Deaths | 18 (2.2) | 24 (2.8) | .43 |
|
| |||
| MedDRA preferred term | |||
| Urinary tract infection | 109 (13.3) | 111 (12.9) | .82 |
|
| |||
| Fall | 83 (10.1) | 77 (9.0) | .42 |
|
| |||
| Dizziness | 47 (5.7) | 73 (8.5) | .03 |
|
| |||
| Diarrhea | 60 (7.3) | 71 (8.3) | .47 |
|
| |||
| Upper respiratory tract infection | 46 (5.6) | 60 (7.0) | .25 |
|
| |||
| Depression | 70 (8.5) | 58 (6.7) | .17 |
|
| |||
| Agitation | 57 (6.9) | 52 (6.0) | .46 |
|
| |||
| Constipation | 35 (4.3) | 49 (5.7) | .18 |
|
| |||
| Nasopharyngitis | 57 (6.9) | 44 (5.1) | .12 |
|
| |||
| Nausea | 48 (5.8) | 40 (4.7) | .27 |
|
| |||
| Headache | 45 (5.5) | 40 (4.7) | .44 |
|
| |||
| Back pain | 41 (5.0) | 30 (3.5) | .13 |
Abbreviation: MedDRA, Medical Dictionary for Regulatory Activities.
a
One participant randomized to placebo and 2 participants randomized to the treatment group discontinued prior to receiving medication and are not included in this table. All percentages and P values are based on the indicated sample sizes.
b
P values were based on the Pearson χ2 test.