Table 3.
Adverse events
| Anti-acid medication at baseline | No anti-acid medication at baseline | |||
|---|---|---|---|---|
| Nintedanib (n = 244) | Placebo (n = 162) | Nintedanib (n = 394) | Placebo (n = 261) | |
| Any adverse event(s) | 235 (96.3) | 152 (93.8) | 374 (94.9) | 227 (87.0) |
| Most frequent adverse event(s)* | ||||
| Diarrhea | 148 (60.7) | 28 (17.3) | 250 (63.5) | 50 (19.2) |
| Nausea | 66 (27.0) | 14 (8.6) | 90 (22.8) | 14 (5.4) |
| Nasopharyngitis | 32 (13.1) | 24 (14.8) | 55 (14.0) | 44 (16.9) |
| Cough | 41 (16.8) | 29 (17.9) | 44 (11.2) | 28 (10.7) |
| Vomiting | 36 (14.8) | 4 (2.5) | 38 (9.6) | 7 (2.7) |
| Decreased appetite | 27 (11.1) | 9 (5.6) | 41 (10.4) | 15 (5.7) |
| Bronchitis | 35 (14.3) | 18 (11.1) | 32 (8.1) | 27 (10.3) |
| Progression of IPF† | 28 (11.5) | 30 (18.5) | 36 (9.1) | 31 (11.9) |
| Weight decreased | 26 (10.7) | 5 (3.1) | 36 (9.1) | 10 (3.8) |
| Upper respiratory tract infection | 20 (8.2) | 18 (11.1) | 38 (9.6) | 24 (9.2) |
| Dyspnea | 23 (9.4) | 22 (13.6) | 26 (6.6) | 26 (10.0) |
| Headache | 25 (10.2) | 8 (4.9) | 18 (4.6) | 11 (4.2) |
| Serious adverse event(s)‡ | 87 (35.7) | 60 (37.0) | 107 (27.2) | 67 (25.7) |
| Severe adverse event(s)§ | 84 (34.4) | 44 (27.2) | 90 (22.8) | 55 (21.1) |
| Fatal adverse event(s) | 20 (8.2) | 15 (9.3) | 17 (4.3) | 16 (6.1) |
| Adverse event(s) leading to treatment discontinuation¶ | 57 (23.4) | 26 (16.0) | 66 (16.8) | 29 (11.1) |
| Diarrhea | 16 (6.6) | 0 (0.0) | 12 (3.0) | 1 (0.4) |
| Progression of IPF† | 5 (2.0) | 12 (7.4) | 8 (2.0) | 9 (3.4) |
| Nausea | 4 (1.6) | 0 (0.0) | 9 (2.3) | 0 (0.0) |
| Pneumonia | 5 (2.0) | 1 (0.6) | 1 (0.3) | 0 (0.0) |
Data shown are n(%) of patients in whom ≥1 such event was reported
*Adverse events reported in ≥10% of patients in any of the subgroups shown
†Corresponds to Medical Dictionary for Regulatory Activities (MedDRA) term ‘IPF’, which included disease worsening and acute exacerbations of IPF
‡An 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
§An event that was incapacitating or that caused an inability to work or to perform usual activities
¶Adverse events leading to treatment discontinuation in ≥2% of patients in any of the subgroups shown