TABLE 5.
Adverse drug reactions of special interest (ADRSI)# in the pre-specified subgroups
| Pre-specified subgroup | Patients | Total events | Patients with event |
| All patients | 1009 (100.0) | 1577 | 693 (68.7) |
| Baseline FVC % pred <50% | 144 (14.3) | 213 | 91 (63.2) |
| Concomitant immunosuppressive therapies | 272 (27.0) | 436 | 190 (69.9) |
| Concomitant other therapies for IPF | 586 (58.1) | 938 | 419 (71.5) |
| Pirfenidone use for conditions other than IPF | 3 (0.3) | 2 | 2 (66.7) |
| Predisposing conditions for liver disease | 190 (18.8) | 246 | 120 (63.2) |
| QT prolongation | 14 (1.4) | 18 | 11 (78.6) |
| Underlying specific cardiac events | 176 (17.4) | 326 | 126 (71.6) |
| Underlying hepatic disease | 43 (4.3) | 83 | 31 (72.1) |
| Underlying other forms of pulmonary disease | 271 (26.9) | 421 | 181 (66.8) |
| Warfarin use | 48 (4.8) | 76 | 34 (70.8) |
| Paediatric patients | 0 (0.0) | ||
| Secondary causes of pulmonary fibrosis | 0 (0.0) |
Data are presented as n (%) or n. FVC: forced vital capacity; IPF: idiopathic pulmonary fibrosis; EMA: European Medicines Agency; CHMP: Committee for Medicinal Products for Human Use. #: ADRSI included any important identified/potential risks identified in the EMA's CHMP assessment report for pirfenidone (important identified risks: photosensitivity reactions/skin rashes, abnormal liver function tests, dizziness, weight loss, gastrointestinal symptoms, fatigue and angioedema; important potential risks: falls, drug interactions (particularly cytochrome P450 CYP1A2 inducers/inhibitors such as cigarette smoke and ciprofloxacin), increased platelet counts, specific cardiac events (including supraventricular tachyarrhythmia, atrioventricular block and sick sinus syndrome, ventricular arrhythmia, bundle branch block and aortic or pulmonic valvular incompetence)) [12]; in addition to these ADRSI included in the EMA's CHMP, this study also included angioedema, blood dyscrasias (specifically agranulocytosis, leukopenia and neutropenia), severe skin reactions and warfarin interactions as important/potential risks (the treating physician (investigator) made a clinical judgement to decide if the ADRSI was related to pirfenidone).