Table 4.
Bleeding events across all patients
| Patient | Treatment group | Antifibrotic treatment | Severity | Description | Associated CVD | Time from anticoagulant/antiplatelet treatment to event (months)a | Duration of antifibrotic treatment to event (months) |
|---|---|---|---|---|---|---|---|
| 1 | Group D | Pirfenidone | Mild | Ear bleeding | Coronary heart disease | 31.4 | 27.9 |
| 2 | Group A | Nintedanib | Mild | Bleeding from hemorrhoids | Arterial hypertension | – | 8.6 |
| 3 | Group A | Nintedanib | Mild | Hemoptysis for 3 weeks | None | – | 2.7 |
| 4 | Group A | Nintedanib | Mild | Bleeding from hemorrhoids | None | – | 10.0 |
| 5 | Group A | Nintedanib | Mild | Epistaxis and hematochezia | Arterial hypertension | – | 0.3 |
| 6 | Group D | Nintedanib | Moderate | Adrenal hematoma |
Coronary heart disease Arrhythmia—especially AFb Heart failure |
80.5 | 0.3 |
| 7 | Group A | Nintedanib | Mild | Hematuria |
Arterial hypertension Arrhythmia—especially AFc |
– | 3.6 |
| 8 | Group C | Nintedanib | Severe | Gastrointestinal hemorrhage | Arterial hypertension | 11.0 | 9.4 |
AF atrial fibrillation, CVD cardiovascular disease
aFive patients had terminated the anticoagulant/antiplatelet treatment before the bleeding event occurred
bType of arrhythmia not specified; patient was treated with propafenone, rivaroxaban and later dabigatran
cSpecified as ‘supraventricular tachyarrhythmia (probably supraventricular)’ by the attending physician