Table 5.
Patients with: | BMS‐986231 treatment dosage | |||||
---|---|---|---|---|---|---|
Placebo group
(n = 12) |
3 µg/kg/min (n = 6) | 5 µg/kg/min (n = 9) | 7 µg/kg/min (n = 12) | 12 µg/kg/min (n = 7) | Combined (n = 34) | |
≥1 TEAE, n (%) | 3 (25.0%) | 5 (83.3%) | 5 (55.6%) | 7 (58.3%) | 3 (42.9%) | 20 (58.8%) |
≥2 TEAEs (for combined active treatment) by preferred term, n (%) | ||||||
Cardiac disorders | ||||||
Cardiac failure | 1 (11.1%) | 1 (8.3%) | 2 (5.9%) | |||
Cardiac failure, congestive | 1 (16.7%) | 1 (11.1%) | 2 (5.9%) | |||
Nervous system disorders | ||||||
Headache | 2 (16.7%) | 1 (14.3%) | 3 (8.8%) | |||
Vascular disorders | ||||||
Hypotension | 1 (8.3%) | 3 (33.3%) | 1 (14.3%) | 4 (11.8%) | ||
≥1 serious TEAE, n (%) | 1 (8.3%) | 3 (50.0%) | 1 (11.1%) | 3 (25.0%) | 1 (14.3%) | 8 (23.5%) |
Cardiac disorders | ||||||
Atrial flutter | 1 (8.3%) | 1 (2.9%) | ||||
Atrioventricular block, complete | 1 (14.3%) | 1 (2.9%) | ||||
Cardiac failure | 1 (8.3%) | 1 (2.9%) | ||||
Cardiac failure, congestive | 1 (16.7%) | 1 (11.1%) | 2 (5.9%) | |||
Infections/infestations | ||||||
Rhinovirus infection | 1 (16.7%)a | 1 (2.9%) | ||||
Metabolism/nutrition disorders | ||||||
Dehydration | 1 (8.3%) | 0 | ||||
Renal and urinary disorders | ||||||
Renal failure | 1 (8.3%) | 1 (2.9%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||
Respiratory failure | 1 (16.7%) | 1 (2.9%) | ||||
Skin and subcutaneous disorders | ||||||
Toxic epidermal necrolysis | 1 (16.7%) | 1 (2.9%) | ||||
≥1 severe TEAE, n (%) | 4 (66.7%) | 2 (16.7%) | 1 (14.3%) | 7 (20.6%) | ||
≥1 fatal TEAE | 1 (16.7%) | 1 (2.9%) | ||||
≥1 drug‐related TEAEb, n (%) | 1 (8.3%) | 1 (11.1%) | 2 (16.7%) | 1 (14.3%) | 4 (11.8%) | |
TEAE leading to drug interruption, n (%) | 0 | |||||
TEAE leading to drug discontinuation, n (%) | 1 (14.3%) | 1 (2.9%) |
This patient received study infusion on 23 July 2014 and was diagnosed with Stevens–Johnson syndrome on 13 August 2014, which was empirically considered by the investigator to be iatrogenic and related to the use of the cephalosporin antibiotic for rhinovirus, and not to the study drug.
No reported study drug‐related TEAEs were serious, severe or fatal.