Table 5.
Incidence of TEAEs (all causalities and treatment related) in ≥5% of subjects overall
| Placebo | PF-00489791 | |||
|---|---|---|---|---|
| System Organ Class Causalities Preferred Term | All Causalities n=64, n (%) | Treatment Related, n (%) | All Causalities n=192, n (%) | Treatment Related, n (%) |
| Blood and lymphatic system disorders | 1 (1.6) | 0 | 10 (5.2) | 0 |
| Gastrointestinal disorders | 8 (12.5) | 1 (1.6) | 46 (24.0) | 20 (10.4) |
| Diarrhea | 2 (3.1) | 0 | 17 (8.9) | 7 (3.6) |
| Dyspepsia | 1 (1.6) | 1 (1.6) | 12 (6.3) | 7 (3.6) |
| Peripheral edema | 6 (9.4) | 1 (1.6) | 12 (6.3) | 1 (0.5) |
| Infections & infestations | 8 (12.5) | 0 | 28 (14.6) | 2 (1.0) |
| Investigations | 11 (17.2) | 1 (1.6) | 23 (12.0) | 5 (2.6) |
| Metabolism & nutrition disorders | 5 (7.8) | 0 | 13 (6.8) | 0 |
| Musculoskeletal & connective tissue disorders | 7 (10.9) | 1 (1.6) | 19 (9.9) | 10 (5.2) |
| Nervous system disorders | 9 (14.1) | 6 (9.4) | 26 (13.5) | 16 (8.3) |
| Headache | 6 (9.4) | 5 (7.8) | 12 (6.3) | 9 (4.7) |
| Renal and urinary disorders | 5 (7.8) | 1 (1.6) | 6 (3.1) | 1 (0.5) |
| Vascular disorders | 5 (7.8) | 2 (3.1) | 14 (7.3) | 2 (1.0) |