MedDRA system organ class | Number (percentage) of subjectsa | |||
---|---|---|---|---|
Heparin cohort | Non-heparin cohort | |||
Tifacogin | Placebo | 0.025 TFPI | Placebo | |
(n = 172) | (n = 167) | (n = 79) | (n = 78) | |
Any serious adverse event | 11 (6%) | 4 (2%) | 3 (4%) | 2 (3%) |
Gastrointestinal disorders | 1 (1%) | 2 (1%) | 2 (3%) | 2 (3%) |
General disorders and administration site condition | 1 (1%) | 1 (1%) | 0 | 0 |
Injury and poisoning | 0 | 1 (1%) | 0 | 0 |
Nervous system disorders | 3 (2%) | 0 | 0 | 0 |
Respiratory, thoracic, and mediastinal disorders | 1 (1%) | 0 | 0 | 0 |
Surgical and medical procedures | 2 (1%) | 0 | 0 | 0 |
Vascular disorders | 3 (2%) | 0 | 1 (1%) | 0 |