Table 3.
Incidence of treatment emergent adverse events that occurred in two or more patients while receiving active treatment (safety population)
| System organ class preferred term | Placebo (N = 13) n (%) | 100 mg (N = 4) n (%) | 200 mg (N = 4) n (%) | 400 mg (N = 4) n (%) | 500 mg (N = 6) n (%) | 600 mg (N = 1) n (%) | Total (N = 13) n (%) |
|---|---|---|---|---|---|---|---|
| Any TEAE | 4 (31) | 1 (25) | 0 | 2 (50) | 6 (100) | 1 (100) | 10 (77) |
| Nervous system disorders | 2 (15) | 1 (25) | 0 | 2 (50) | 5 (83) | 1 (100) | 9 (69) |
| Dizziness | 1 (8) | 1 (25) | 0 | 2 (50) | 5 (83) | 1 (100) | 9 (69) |
| Somnolence | 0 | 1 (25) | 0 | 0 | 4 (67) | 0 | 5 (38) |
| Ataxia | 0 | 0 | 0 | 0 | 2 (33) | 0 | 2 (15) |
| Tremor | 0 | 0 | 0 | 0 | 2 (33) | 0 | 2 (15) |
| General disorders and administration site conditions | 0 | 0 | 0 | 0 | 2 (33) | 1 (100) | 3 (23) |
| Fatigue | 0 | 0 | 0 | 0 | 2 (33) | 1 (100) | 3 (23) |
| Musculoskeletal and connective tissue disorders | 0 | 0 | 0 | 0 | 2 (33) | 0 | 2 (15) |
| Muscle twitching | 0 | 0 | 0 | 0 | 2 (33) | 0 | 2 (15) |
AE, adverse event; MedDRA, medical dictionary for regulatory activities; TEAE, treatment-emergent adverse event.
TEAEs were attributed to ICA-105665 for any AEs starting or worsening on or after the date and time of ICA-105665 dose on day 2. TEAEs were attributed to placebo for any AEs occurring before ICA-105665 dose on day 2, but after placebo dose on day 1. Each patient was counted only once in the Total column for patients returning for a higher dose. At each level of patient summarization, a patient was counted once if the patient reported multiple events within the same Preferred Term of System Organ Class. System Organ Classes and Preferred Terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 12.1 (Italian Publishers Association, Milan, Italy).