AEs in participants treated with emicizumab across HAVEN 1-4 over a median exposure of 130.3 weeks (range, 3.4-221.1)
| . | Total (N = 399)* . |
|---|---|
| Participants with ≥1 AE | 381 (95.5) |
| AE with fatal outcome | 1 (0.3) |
| SAE | 93 (23.3) |
| AE leading to withdrawal from treatment | 5 (1.3) |
| AE leading to dose modification/interruption | 9 (2.3) |
| Grade ≥3 AE | 87 (21.8) |
| ISR† | 111 (27.8) |
| AEs of special interest | |
| Systemic hypersensitivity/anaphylactic/anaphylactoid reaction‡ | 1 (0.3) |
| TMA associated with concomitant aPCC and emicizumab | 3 (0.8) |
| Other TMA | 0 |
| TE associated with concomitant aPCC and emicizumab | 2 (0.5) |
| Other TE | 2 (0.5) |
| . | Total (N = 399)* . |
|---|---|
| Participants with ≥1 AE | 381 (95.5) |
| AE with fatal outcome | 1 (0.3) |
| SAE | 93 (23.3) |
| AE leading to withdrawal from treatment | 5 (1.3) |
| AE leading to dose modification/interruption | 9 (2.3) |
| Grade ≥3 AE | 87 (21.8) |
| ISR† | 111 (27.8) |
| AEs of special interest | |
| Systemic hypersensitivity/anaphylactic/anaphylactoid reaction‡ | 1 (0.3) |
| TMA associated with concomitant aPCC and emicizumab | 3 (0.8) |
| Other TMA | 0 |
| TE associated with concomitant aPCC and emicizumab | 2 (0.5) |
| Other TE | 2 (0.5) |
All data are n (%). Multiple occurrences of the same AE in each participant are counted only once.
The safety population included only those participants who received emicizumab. This excludes 1 participant in HAVEN 1 who discontinued prior to emicizumab treatment and 1 additional participant from HAVEN 3 who was assigned to no prophylaxis and was lost to follow-up and not treated.
All ISRs, regardless of relatedness to treatment. The majority of local ISRs were mild (104/111; 93.7%).
Assessed using Sampson criteria and includes all participants who experienced indicative symptoms. One participant was identified through algorithmic analysis as potentially having a systemic hypersensitivity/anaphylactic/anaphylactoid reaction (he had experienced symptoms of abdominal pain and cough); however, medical review of the case showed that Sampson criteria were not met.