Table 2.
Nintedanib n =18 |
Placebo n=12 |
|
---|---|---|
Grade 2+ AEs | 16 | 5 |
Systemic | ||
Fatigue | 1 (6%) | 1 (8%) |
Anorexia | 1 (6%) | - |
Respiratory | ||
Cough | - | 1 (8%) |
Dyspnea | 3 (17%) | - |
Hypoxia | 1 (6%) | - |
Lung Infection | 2 (11%) | - |
Pleural effusion | 1 (6%) | - |
Gastrointestinal | ||
Diarrhea | 3 (17%) | - |
Nausea | - | 1 (8%) |
Cardiovascular/Hematologic | ||
Pericardial effusion | 1 (6%) | - |
Hypertension | 1 (6%) | - |
Platelet count decreased | 1 (6%) | - |
Lymphocyte count decreased | - | 1 (8%) |
Thromboembolic event | 1 (6%) | - |
Skin | ||
Rash | - | 1 (8%) |
Grade 2 or higher adverse events that were possibly or probably attributed to the study intervention. Reported as number of patients with at least one occurrence of listed event (percent). No grade 2 events were definitely attributed to intervention. Some patients had multiple adverse events. Two deaths occurred in nintedanib group, unlikely related to study. A full list of all AEs can be found in the supplemental material.