Table 4.
Overall summary of TEAEs through 49 days post-dose
| Subjects,* n (%) with ≥ 1 event | MEDI3902 500 mg (N = 16) | MEDI3902 1500 mg (N = 85) | Placebo (N = 83) |
|---|---|---|---|
| TEAE | 15 (93.8) | 84 (98.8) | 81 (97.6) |
| Treatment-related TEAE | 0 (0.0) | 3 (3.5) | 1 (1.2) |
| TEAE of ≥ grade 3 severity† | 12 (75.0) | 60 (70.6) | 54 (65.1) |
| Death (grade 5 severity†) | 3 (18.8) | 24 (28.2) | 19 (22.9) |
| Serious‡ TEAE | 4 (25.0) | 38 (44.7) | 35 (42.2) |
| Serious‡ and/or ≥ grade 3 severity† TEAE | 12 (75.0) | 60 (70.6) | 55 (66.3) |
| Treatment-related serious‡ TEAE | 0 (0.0) | 0 (0.0) | 1 (1.2) |
| TEAE leading to discontinuation of treatment | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| AESI§ | 0 (0.0) | 2 (2.4) | 1 (1.2) |
| Treatment-related AESI§ | 0 (0.0) | 2 (2.4) | 0 (0.0) |
| AESI§ of ≥ grade 3 severity† | 0 (0.0) | 1 (1.2) | 1 (1.2) |
AE adverse event, AESI adverse event of special interest, TEAE treatment-emergent adverse event
*Subjects are counted once for each category regardless of the number of events; †grade 3, severe; grade 4, life-threatening; grade 5, fatal; ‡serious adverse event criteria: death, life-threatening, required inpatient hospitalisation, prolongation of existing hospitalisation, persistent or significant disability/incapacity, important medical event, congenital anomaly/disorder (in the offspring of the subject); §AESI defined as targeted AEs of hepatic function abnormalities, hypersensitivity reactions (including anaphylaxis), infusion-related reactions, and immune complex disease (including vasculitis, endocarditis, neuritis, and glomerulonephritis)