Table 1.
Gastrointestinal adverse events in the CAPACITY studies
| Nausea | Diarrhea | Dyspepsia | Vomiting | |||||
|---|---|---|---|---|---|---|---|---|
| Pirfenidone 2,403 mg/day (N = 345) | Placebo (N = 347) | Pirfenidone 2,403 mg/day (N = 345) | Placebo (N = 347) | 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 (%) | 6 (1.7) | 2 (0.6) | 2 (0.6) | 0 (0.0) | 1 (0.3) | 2 (0.6) | 1 (0.3) | 0 (0.0) |
| TE SAE, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Deaths, n | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hospitalizations, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinuation, n (%) | 5 (1.4) | 0 (0.0) | 0 (0.0) | 2 (0.6) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) |
| Dose modification, n (%) | 25 (7.2) | 7 (2.0) | 18 (5.2) | 4 (1.2) | 8 (2.3) | 0 (0.0) | 14 (4.1) | 3 (0.9) |
| Events, n | 195 | 77 | 153 | 85 | 77 | 29 | 62 | 17 |
| Median duration, days | 46 | 7 | 7 | 5 | 168 | 4 | 2 | 3 |
| Resolved, n (%) | 149 (76) | 65 (84) | 130 (85) | 73 (52) | 40 (52) | 23 (79) | 59 (95) | 17 (100) |
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