Significant adverse events#
| Adverse event | High dose | Low dose | Placebo | p-value¶ | ||
| High dose versus placebo | Low dose versus placebo | High dose versus low dose | ||||
| Subjects | 109 | 55 | 107 | |||
| Any adverse event | 109 (100.0) | 54 (98.2) | 106 (99.1) | 0.50 | 1.00 | 0.34 |
| Photosensitivity | 56 (51.4) | 29 (52.7) | 24 (22.4) | <0.01 | <0.01 | 1.00 |
| Eczema asteatotic | 0 (0.0) | 3 (5.5) | 0 (0.0) | 0.04 | 0.04 | |
| Anorexia | 18 (16.5) | 6 (10.9) | 3 (2.8) | <0.01 | 0.06 | 0.48 |
| Abdominal discomfort | 3 (2.8) | 4 (7.3) | 0 (0.0) | 0.25 | 0.01 | 0.23 |
| Dizziness | 8 (7.3) | 0 (0.0) | 1 (0.9) | 0.04 | 1.00 | 0.05 |
| Nasopharyngitis | 54 (49.5) | 30 (54.5) | 70 (65.4) | 0.02 | 0.23 | 0.62 |
| Upper respiratory tract infection | 1 (0.9) | 3 (5.5) | 9 (8.4) | <0.01 | 0.75 | 0.11 |
| γ-GTP elevation | 25 (22.9) | 12 (21.8) | 10 (9.3) | <0.01 | 0.05 | 1.00 |
| WBC decrease | 4 (3.7) | 3 (5.5) | 0 (0.0) | 0.12 | 0.04 | 0.69 |
Data are presented as n or n (%), unless otherwise stated. #: events which were observed with an incidence of ≥5% during the study period and for which a significant difference was detected between the placebo group and each of the pirfenidone treatment groups, high dose or low dose (p<0.05); ¶: using Fisher’s exact test. γ-GTP: γ-glutamyl-transpeptidase; WBC: white blood cell.