Table 4 Gastrointestinal adverse events and clinical consequences in the INPULSIS® trials
From: Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis
Diarrhea | Nausea | Vomiting | ||||
|---|---|---|---|---|---|---|
Nintedanib | Placebo | Nintedanib | Placebo | Nintedanib | Placebo | |
(n = 398) | (n = 78) | (n = 156) | (n = 28) | (n = 74) | (n = 11) | |
Intensity of adverse eventa | ||||||
Mild | 226 (56.8) | 60 (76.9) | 116 (74.4) | 26 (92.9) | 49 (66.2) | 9 (81.8) |
Moderate | 150 (37.7) | 16 (20.5) | 38 (24.4) | 2 (7.1) | 21 (28.4) | 2 (18.2) |
Severe | 21 (5.3) | 2 (2.6) | 2 (1.3) | 0 (0.0) | 4 (5.4) | 0 (0.0) |
Outcome of adverse eventa | ||||||
Recovered | 350 (87.9) | 72 (92.3) | 143 (91.7) | 22 (78.6) | 69 (93.2) | 11 (100.0) |
Not yet recoveredb | 43 (10.8) | 6 (7.7) | 12 (7.7) | 6 (21.4) | 5 (6.8) | 0 (0.0) |
Fatal | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Unknown | 5 (1.3) | 0 (0.0) | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Consequence for dosingc | ||||||
No permanent dose reduction or discontinuationd | 313 (78.6) | 77 (98.7) | 135 (86.5) | 28 (100.0) | 64 (86.5) | 11 (100.0) |
Permanent dose reduction of trial drug | 57 (14.3) | 0 (0.0) | 8 (5.1) | 0 (0.0) | 5 (6.8) | 0 (0.0) |
Permanent discontinuation of trial drug | 28 (7.0) | 1 (1.3) | 13 (8.3) | 0 (0.0) | 5 (6.8) | 0 (0.0) |
Number of adverse events | ||||||
1 | 240 (60.3) | 60 (76.9) | 116 (74.4) | 27 (96.4) | 54 (73.0) | 11 (100.0) |
2 | 105 (26.4) | 12 (15.4) | 31 (19.9) | 1 (3.6) | 14 (18.9) | 0 (0.0) |
3 | 29 (7.3) | 3 (3.8) | 8 (5.1) | 0 (0.0) | 4 (5.4) | 0 (0.0) |
≥ 4 | 24 (6.0) | 3 (3.8) | 1 (0.6) | 0 (0.0) | 2 (2.7) | 0 (0.0) |
Duration of events, days, median (minimum, maximum)e | 138.5 (1, 473) | 7.0 (1, 453) | 44.0 (1, 400) | 51.0 (1, 404) | 6.0 (1, 390) | 1.0 (1, 4) |