Table 3 Incidence of treatment-emergent adverse events a
AEs, n (%) | PBO/RIS | RIS/RIS | Direct-enroll | All subjects |
|---|---|---|---|---|
(n = 48) | (n = 292) | (n = 50) | (N = 390) | |
Treatment-emergent AEs | ||||
Total | 42 (88) | 247 (85) | 46 (92) | 335 (86) |
Most common AEs (≥ 10% in any group) | ||||
Somnolence | 16 (33) | 72 (25) | 18 (36) | 106 (27) |
Headache | 6 (13) | 49 (17) | 16 (32) | 71 (18) |
Weight increase | 7 (15) | 39 (13) | 14 (28) | 60 (15) |
Hypertonia | 7 (15) | 37 (13) | 8 (16) | 52 (13) |
Insomnia | 7 (15) | 35 (12) | 4 (8) | 46 (12) |
Psychosis | 3 (6) | 31 (11) | 7 (14) | 41 (11) |
Tremor | 6 (13) | 32 (11) | 4 (8) | 42 (11) |
Rhinitis | 4 (8) | 29 (10) | 1 (2) | 34 (9) |
Extrapyramidal disorder | 5 (10) | 23 (8) | 2 (4) | 30 (8) |
Depression | 5 (10) | 17 (6) | 5 (10) | 27 (7) |
Agitation | 5 (10) | 19 (7) | 2 (4) | 26 (7) |
Fatigue | 1 (2) | 17 (6) | 8 (16) | 26 (7) |
Tachycardia | 9 (19) | 16 (5) | 1 (2) | 26 (7) |
Vomiting | 6 (13) | 19 (7) | 1 (2) | 26 (7) |
Abdominal pain | 1 (2) | 10 (3) | 9 (18) | 20 (5) |
Serious | ||||
Total | 4 (8) | 46 (16) | 14 (28) | 64 (16) |
Psychosis | 1 (2) | 26 (9) | 8 (16) | 35 (9) |
Suicide attempt | 1 (2) | 14 (5) | 3 (6) | 18 (5) |
Aggressive reaction | 0 | 5 (2) | 1 (2) | 6 (2) |
Injury | 0 | 3 (1) | 2 (4) | 5 (1) |
Depression | 0 | 4 (1) | 0 | 4 (1) |
Anxiety | 0 | 2 (1) | 1 (2) | 3 (1) |
Paranoid reaction | 0 | 1 (<-1) | 2 (4) | 3 (1) |
Emotional lability | 0 | 1 (<-1) | 1 (2) | 2 (1) |
Inflicted injury | 0 | 2 (1) | 0 | 2 (1) |
Agitation | 0 | 0 | 1 (2) | 1 (<-1) |
Convulsions | 0 | 1 (<-1) | 0 | 1 (<-1) |
Diabetes mellitus | 0 | 1 (<-1) | 0 | 1 (<-1) |
Delusion | 0 | 0 | 1 (2) | 1 (<-1) |
Depression psychotic | 0 | 0 | 1 (2) | 1 (<-1) |
Drug abuse | 0 | 0 | 1 (2) | 1 (<-1) |
Gastrointestinal hemorrhage | 1 (2) | 0 | 0 | 1 (<-1) |
Laboratory values abnormal | 0 | 1 (<-1) | 0 | 1 (<-1) |
Medication error | 0 | 0 | 1 (2) | 1 (<-1) |
Metastases not otherwise specified | 1 (2) | 0 | 0 | 1 (<-1) |
Pharyngitis | 0 | 1 (<-1) | 0 | 1 (<-1) |
Sarcoma | 1 (2) | 0 | 0 | 1 (<-1) |
Schizophrenic reaction | 0 | 1 (<-1) | 0 | 1 (<-1) |
Vomiting | 1 (2) | 0 | 0 | 1 (<-1) |