Table 2.
Skin-related adverse events in the CAPACITY studies
| Rash | Photosensitivity reaction | |||
|---|---|---|---|---|
| Pirfenidone 2,403 mg/day (N = 345) | Placebo (N = 347) | Pirfenidone 2,403 mg/day (N = 345) | Placebo (N = 347) | |
| Grade 3 or 4 TEAEs, n (%) | 2 (0.6) | 0 (0.0) | 3 (0.9) | 1 (0.3) |
| TE SAEs, n (%) | 1 (0.3)a | 0 (0.0) | 1 (0.3) | 0 (0.0) |
| Deaths (n) | 0 | 0 | 0 | 0 |
| Hospitalization, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinuation, n (%) | 5 (1.4) | 0 (0.0) | 3 (0.9) | 1 (0.3) |
| Dose modification, n (%) | 42 (12.2) | 5 (1.5) | 19 (5.5) | 1 (0.3) |
| Events (n) | 159 | 52 | 60 | 8 |
| Median duration (days) | 38 | 31 | 88 | 60 |
| Resolved, n (%) | 132 (83) | 46 (88) | 47 (78) | 6 (75) |
No formal definition of rash versus photosensitivity reaction was employed; the distinction was made by the physician based on his/her clinical observation
TEAE treatment-emergent adverse event, TE SAE treatment-emergent severe adverse event, Grade 3 TEAE severe or medically significant but not immediately life-threatening events; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care Activities of Daily Living, Grade 4 TEAE life-threatening consequences; urgent intervention indicated. InterMune data on file
aGrade 3 erythema with desquamation