Table 3.
Summary of Treatment-Emergent Adverse Events (Safety Population)
| Overall, N (%) | Placebo, N = 72 | ABT-288 10mg, N = 72 | ABT-288 25mg, N = 69 | Total, N = 213 |
|---|---|---|---|---|
| Any adverse event | 41 (56.9) | 48 (66.7) | 38 (55.1) | 127 (59.6) |
| Discontinued due to an adverse event* | 1 (1.4) | 10 (13.9) | 6 (8.7) | 17 (8.0) |
| Possibly or probably drug relateda,** | 16 (22.2) | 28 (38.9) | 27 (39.1) | 71 (33.3) |
| Severe adverse event | 3 (4.2) | 5 (6.9) | 2 (2.9) | 10 (4.7) |
| Moderate adverse eventb | 15 (20.8) | 20 (27.8) | 19 (27.5) | 54 (25.4) |
| Mild adverse eventc | 23 (31.9) | 23 (31.9) | 17 (24.6) | 63 (29.6) |
| Serious adverse event | 3 (4.2) | 5 (6.9) | 3 (4.3) | 11 (5.2) |
| Adverse events reported by for 4 or more subjects taking ABT-288 | ||||
| MedDRA preferred term, N (%) | ||||
| Insomnia | 4 (5.6) | 12 (16.7) | 9 (13.0) | 25 (11.7) |
| Headache | 3 (4.2) | 9 (12.5) | 3 (4.3) | 15 (7.0) |
| Nausea | 3 (4.2) | 8 (11.1) | 4 (5.8) | 15 (7.0) |
| Dizziness | 2 (2.8) | 2 (2.8) | 8 (11.6) | 12 (5.6) |
| Dry mouth | 4 (5.6) | 2 (2.8) | 6 (8.7) | 12 (5.6) |
| Hypertension | 2 (2.8) | 4 (5.6) | 3 (4.3) | 9 (4.2) |
| Psychotic disorder | 3 (4.2) | 3 (4.2) | 3 (4.3) | 9 (4.2) |
| Abnormal dreams | 1 (1.4) | 4 (5.6) | 3 (4.3) | 8 (3.8) |
| Cough | 3 (4.2) | 2 (2.8) | 3 (4.3) | 8 (3.8) |
| Nasopharyngitis | 2 (2.8) | 2 (2.8) | 4 (5.8) | 8 (3.8) |
| Anxiety | 0 | 4 (5.6) | 3 (4.3) | 7 (3.3) |
| Diarrhoea | 2 (2.8) | 2 (2.8) | 3 (4.3) | 7 (3.3) |
| Depression | 0 | 4 (5.6) | 2 (2.9) | 6 (2.8) |
| Agitation | 1 (1.4) | 2 (2.8) | 2 (2.9) | 5 (2.3) |
| Hot flush | 0 | 2 (2.8) | 3 (4.3) | 5 (2.3) |
| Adverse events of special interestd | ||||
| Psychosis and psychotic disorders | 4 (5.6) | 8 (11.1) | 11 (15.9) | 23 (10.8) |
| Hostility and aggression | 6 (8.3) | 8 (11.1) | 8 (11.6) | 22 (10.3) |
| Sleep disorders and disturbances* | 5 (6.9) | 15 (20.8) | 10 (14.5) | 30 (14.1) |
| Arrhythmia-related investigations, signs, and symptoms | 1 (1.4) | 2 (2.8) | 2 (2.9) | 5 (2.3) |
| Suicide/self-injury | 0 | 2 (2.8) | 3 (4.3) | 5 (2.3) |
Note: MedDRA, Medical Dictionary for Regulatory Activities.
aInvestigator believed the event was possibly or probably related to study drug.
bSubjects whose most severe adverse event was rated as “moderate” by the investigator.
cSubjects whose most severe adverse event was rated as “mild” by the investigator.
dStandardized MedDRA Query or MedDRA High Level Group Term.
*P < .05 for ABT-288 10mg and both doses of ABT-288 combined vs placebo (Fisher’s exact test).
**P < .05 for ABT-288 10mg, ABT-126 25mg, and both doses of ABT-288 vs placebo (Fisher’s exact test).