Table 1 Summary of common adverse eventsa and reasons for treatment discontinuation by IPF severity at RECAP baseline
From: Effect of pirfenidone in patients with more advanced idiopathic pulmonary fibrosis
More advanced disease (n = 187) | Less advanced disease (n = 409) | Total (n = 596) | |
|---|---|---|---|
Number of patients with ≥1 adverse event in the first 180 weeks of treatment, n (%) | |||
Total | 187 (100.0) | 408 (99.8) | 595 (99.8) |
Cough | 96 (51.3) | 209 (51.1) | 305 (51.2) |
Dyspnoea | 105 (56.1) | 162 (39.6) | 267 (44.8) |
Fatigue | 68 (36.4) | 164 (40.1) | 232 (38.9) |
Worsening of IPFb | 109 (58.3) | 112 (27.4) | 221 (37.1) |
Nausea | 56 (29.9) | 154 (37.7) | 210 (35.2) |
Upper respiratory tract infection | 61 (32.6) | 137 (33.5) | 198 (33.2) |
Bronchitis | 51 (27.3) | 130 (31.8) | 181 (30.4) |
Diarrhoea | 44 (23.5) | 123 (30.1) | 167 (28.0) |
Nasopharyngitis | 40 (21.4) | 117 (28.6) | 157 (26.3) |
Dizziness | 39 (20.9) | 105 (25.7) | 144 (24.2) |
Headache | 37 (19.8) | 98 (24.0) | 135 (22.7) |
Back pain | 36 (19.3) | 91 (22.2) | 127 (21.3) |
Dyspepsia | 26 (13.9) | 96 (23.5) | 122 (20.5) |
Reasons for discontinuation, n (%) | |||
All reasons | 134 (71.7) | 177 (43.3) | 311 (52.2) |
Adverse event | 81 (43.3) | 110 (26.9) | 191 (32.0) |
Related to IPFc | 26 (13.9) | 21 (5.1) | 47 (7.9) |
Not related to IPF | 55 (29.4) | 89 (21.8) | 144 (24.2) |
Withdrawal by patient | 16 (8.6) | 35 (8.6) | 51 (8.6) |
Death | 20 (10.7) | 13 (3.2) | 33 (5.5) |
Lung transplantation | 12 (6.4) | 14 (3.4) | 26 (4.4) |
Physician decision | 5 (2.7) | 3 (0.7) | 8 (1.3) |
Other | 0 (0.0) | 2 (0.5) | 2 (0.3) |