BMI < 25 kg/m2 | BMI ≥ 25 to < 30 kg/m2 | BMI ≥ 30 kg/m2 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Nintedanib (n = 90) | Placebo (n = 98) | Nintedanib (n = 130) | Placebo (n = 112) | Nintedanib (n = 111) | Placebo (n = 121) | |||||||
n (%) | Rate per 100 patient-years | n (%) | Rate per 100 patient-years | n (%) | Rate per 100 patient-years | n (%) | Rate per 100 patient-years | n (%) | Rate per 100 patient-years | n (%) | Rate per 100 patient-years | |
Any adverse event(s) | 89 (98.9) | 1048.3 | 95 (96.9) | 435.8 | 127 (97.7) | 589.3 | 104 (92.9) | 288.4 | 109 (98.2) | 716.1 | 109 (90.1) | 281.7 |
Most frequent adverse eventsa | ||||||||||||
Diarrhea | 71 (78.9) | 199.2 | 25 (25.5) | 23.3 | 92 (70.8) | 130.9 | 29 (25.9) | 23.3 | 77 (69.4) | 112.8 | 31 (25.6) | 22.5 |
Nausea | 27 (30.0) | 30.7 | 9 (9.2) | 6.9 | 39 (30.0) | 30.5 | 11 (9.8) | 7.4 | 33 (29.7) | 30.5 | 13 (10.7) | 8.2 |
Vomiting | 19 (21.1) | 18.2 | 3 (3.1) | 2.2 | 21 (16.2) | 14.9 | 5 (4.5) | 3.3 | 24 (21.6) | 19.4 | 8 (6.6) | 4.8 |
Decreased appetite | 21 (23.3) | 22.1 | 9 (9.2) | 6.8 | 18 (13.8) | 11.9 | 7 (6.3) | 4.6 | 15 (13.5) | 10.8 | 7 (5.8) | 4.2 |
Nasopharyngitis | 19 (21.1) | 19.9 | 23 (23.5) | 20.2 | 21 (16.2) | 14.3 | 14 (12.5) | 9.5 | 14 (12.6) | 9.7 | 11 (9.1) | 6.9 |
Dyspnea | 14 (15.6) | 13.0 | 11 (11.2) | 8.4 | 19 (14.6) | 12.6 | 27 (24.1) | 19.4 | 19 (17.1) | 13.4 | 19 (15.7) | 12.0 |
Bronchitis | 12 (13.3) | 11.2 | 19 (19.4) | 15.5 | 21 (16.2) | 14.4 | 20 (17.9) | 14.3 | 15 (13.5) | 10.7 | 25 (20.7) | 16.4 |
Weight decrease | 19 (21.1) | 18.8 | 7 (7.1) | 5.2 | 18 (13.8) | 12.0 | 8 (7.1) | 5.2 | 12 (10.8) | 8.5 | 3 (2.5) | 1.7 |
ALT increased | 14 (15.6) | 13.9 | 2 (2.0) | 1.5 | 18 (13.8) | 11.9 | 5 (4.5) | 3.2 | 17 (15.3) | 12.0 | 6 (5.0) | 3.6 |
Cough | 8 (8.9) | 7.2 | 9 (9.2) | 6.9 | 15 (11.5) | 9.8 | 12 (10.7) | 8.1 | 17 (15.3) | 12.1 | 30 (24.8) | 20.8 |
Progression of ILDb | 9 (10.0) | 8.1 | 27 (27.6) | 22.3 | 12 (9.2) | 7.3 | 17 (15.2) | 11.1 | 7 (6.3) | 4.6 | 12 (9.9) | 7.2 |
AST increased | 15 (16.7) | 15.2 | 2 (2.0) | 1.5 | 13 (10.0) | 8.5 | 4 (3.6) | 2.6 | 15 (13.5) | 10.3 | 7 (5.8) | 4.2 |
Adverse event(s) leading to treatment discontinuation | 27 (30.0) | 24.0 | 18 (18.4) | 13.2 | 27 (20.8) | 16.6 | 15 (13.4) | 9.5 | 19 (17.1) | 12.4 | 15 (12.4) | 8.8 |
Adverse event(s) leading to dose reduction | 44 (48.9) | 63.8 | 4 (4.1) | 3.0 | 46 (35.4) | 40.0 | 2 (1.8) | 1.3 | 34 (30.6) | 28.2 | 9 (7.4) | 5.4 |
Serious adverse event(s)c | 42 (46.7) | 46.4 | 57 (58.2) | 56.0 | 59 (45.4) | 44.2 | 57 (50.9) | 45.4 | 46 (41.4) | 36.7 | 50 (41.3) | 35.0 |
Fatal adverse event(s) | 4 (4.4) | 3.4 | 12 (12.2) | 8.7 | 10 (7.7) | 6.0 | 16 (14.3) | 10.1 | 7 (6.3) | 4.5 | 8 (6.6) | 4.6 |