Table 4: Most frequent adverse events reported over 6 months of randomized treatment.
| - |
Nintedanib
(n=56)
|
Placebo
(n=57)
|
| Any adverse event(s) |
55 (98.2) |
51 (89.5) |
| Most frequent adverse event(s)* |
- |
- |
| Diarrhea |
38 (67.9) |
18 (31.6) |
| Nausea |
16 (28.6) |
11 (19.3) |
| Fatigue |
10 (17.9) |
6 (10.5) |
| Decreased appetite |
9 (16.1) |
4 (7.0) |
| Vomiting |
9 (16.1) |
2 (3.5) |
| Headache |
7 (12.5) |
6 (10.5) |
| Cough |
4 (7.1) |
7 (12.3) |
| Any serious adverse event(s)†
|
4 (7.1) |
7 (12.3) |
| Fatal adverse event |
1 (1.8) |
4 (7.0) |
| Any adverse event(s) leading to treatment discontinuation |
5 (8.9) |
3 (5.3) |
| Progression of IPF‡
|
0 (0.0) |
3 (5.3) |
| Other |
5 (8.9) |
0 (0.0) |
Data shown are n (%) of patients in whom ≥1 such adverse event was reported. *Adverse events reported in >12% of patients in either treatment group. †Event that resulted in death, was immediately life-threatening, resulted in persistent or clinically significant disability or incapacity, required or prolonged hospitalization, was related to a congenital anomaly or birth defect, or was deemed serious for any other reason. ‡Corresponds to Medical Dictionary for Regulatory Activities term ‘IPF’, which included disease worsening and acute exacerbations of IPF. IPF, idiopathic pulmonary fibrosis.