Table 3.
Part B: treatment-emergent adverse events
| System Organ Class Preferred Term | All Placebo (n = 6) |
All BITS7201A (n = 20) |
Cohort F 150-mg SC (n = 7) |
Cohort G 300-mg SC (n = 6) |
Cohort H 600-mg SC (n = 6) |
Cohort Ia 600-mg SC (n = 1) |
|---|---|---|---|---|---|---|
| Total number of TEAEs | 3 | 8 | 4 | 2 | 2 | 0 |
| Number of subjects with at least 1 TEAE | 3 (50.0) | 6 (30.0) | 3 (42.9) | 1 (16.7) | 2 (33.3) | 0 |
| General disorders and administration site conditions | 0 | 4 (20.0) | 2 (28.6) | 0 | 2 (33.3) | 0 |
| Influenza like illness | 0 | 2 (10.0) | 0 | 0 | 2 (33.3) | 0 |
| Drug withdrawal syndrome | 0 | 1 (5.0) | 1 (14.3) | 0 | 0 | 0 |
| Injection site bruising | 0 | 1 (5.0) | 1 (14.3) | 0 | 0 | 0 |
| Infections and infestations | 1 (16.7) | 2 (10.0) | 2 (28.6) | 0 | 0 | 0 |
| Otitis media | 1 (16.7) | 0 | 0 | 0 | 0 | 0 |
| Strongyloidiasis | 0 | 1 (5.0) | 1 (14.3) | 0 | 0 | 0 |
| Viral upper respiratory tract infection | 0 | 1 (5.0) | 1 (14.3) | 0 | 0 | 0 |
| Nervous system disorders | 2 (33.3) | 1 (5.0) | 0 | 1 (16.7) | 0 | 0 |
| Headache | 1 (16.7) | 0 | 0 | 0 | 0 | 0 |
| Nerve compression | 1 (16.7) | 0 | 0 | 0 | 0 | 0 |
| Syncope | 0 | 1 (5.0) | 0 | 1 (16.7) | 0 | 0 |
| Skin and subcutaneous tissue disorders | 0 | 1 (5.0) | 0 | 1 (16.7) | 0 | 0 |
| Erythema | 0 | 1 (5.0) | 0 | 1 (16.7) | 0 | 0 |
Data are number of subjects (%). SC subcutaneous, TEAE treatment emergent adverse event
aSubjects with mild atopic asthma