Table 3 Adverse events
From: Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS® trials
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) |