TABLE 2.
Summary of adverse events of BRII-196-001 study.
| BRII-196 750 mg (n = 3) | BRII-196 1500 mg (n = 6) | BRII-196 3,000 mg (n = 3) | Placebo (n = 4) | |
|---|---|---|---|---|
| Participants with any TEAE | 3 (100%) | 5 (83%) | 2 (67%) | 4 (100%) |
| Participants with Grade 1 TEAE | 3 (100%) | 5 (83%) | 2 (67%) | 4 (100%) |
| Participants with Grade 2 TEAE | 1 (33%) | 3 (50%) | 0 | 2 (50%) |
| Participants with Grade 3 or above TEAE | 0 | 0 | 0 | 0 |
| Participants with serious TEAE | 0 | 0 | 0 | 0 |
| Participants with infusion reaction TEAE | 0 | 0 | 0 | 0 |
| Participants with TEAEs related to study drug | 1 (33%) | 3 (50%) | 0 | 0 |
| Participants with any TEAE leading to discontinuation of study drug | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 |
| Number of participants with AEs by MedDRA SOC a | ||||
| Investigations | 3 (100%) | 4 (67%) | 2 (67%) | 4 (100%) |
| Infections and infestations | 1 (33%) | 0 | 0 | 2 (50%) |
Abbreviations: TEAE, treatment-emergent adverse event; SOC, system organ class. Participants who experienced the same AE on more than one occasion (based on the specific category) are counted once in each relevant category. Percentages are based on the number of participants in the treatment group.
a
Only SOCs experienced by ≥ 2 participant or with the maximum severity category ≥ Grade 2 are included.