Table 5.
Incidence of adverse drug reactions before and after nintedanib dose reduction in the safety analysis set (N = 1595)
| MedDRA PT | ADR severity | ADR incidence, n (%) | p-valuea | |
|---|---|---|---|---|
| Pre-dose reduction | Post-dose reduction | |||
| Diarrhoea | Total | 592 (37.1) | 301 (18.9) | < 0.001 |
| Mild | 401 (25.1) | 219 (13.7) | < 0.001 | |
| Moderate | 214 (13.4) | 89 (5.6) | < 0.001 | |
| Severe | 8 (0.5) | 6 (0.4) | 0.774 | |
| Missing | 5 (0.3) | 1 (0.1) | 0.125 | |
| Hepatic function abnormal | Total | 363 (22.8) | 119 (7.5) | < 0.001 |
| Mild | 287 (18.0) | 96 (6.0) | < 0.001 | |
| Moderate | 73 (4.6) | 21 (1.3) | < 0.001 | |
| Severe | 5 (0.3) | 2 (0.1) | 0.453 | |
| Missing | 1 (0.1) | 0 | – | |
| Liver disorder | Total | 203 (12.7) | 71 (4.5) | < 0.001 |
| Mild | 160 (10.0) | 61 (3.8) | < 0.001 | |
| Moderate | 43 (2.7) | 11 (0.7) | < 0.001 | |
| Severe | 1 (0.1) | 0 | – | |
| Missing | 0 | 0 | – | |
| Decreased appetite | Total | 170 (10.7) | 104 (6.5) | < 0.001 |
| Mild | 90 (5.6) | 51 (3.2) | < 0.001 | |
| Moderate | 74 (4.6) | 51 (3.2) | 0.035 | |
| Severe | 5 (0.3) | 4 (0.3) | 1.000 | |
| Missing | 4 (0.3) | 0 | – | |
| Nausea | Total | 119 (7.5) | 54 (3.4) | < 0.001 |
| Mild | 90 (5.6) | 38 (2.4) | < 0.001 | |
| Moderate | 28 (1.8) | 17 (1.1) | 0.117 | |
| Severe | 1 (0.1) | 0 | – | |
| Missing | 4 (0.3) | 0 | – | |
| Vomiting | Total | 36 (2.3) | 20 (1.3) | 0.026 |
| Mild | 26 (1.6) | 11 (0.7) | 0.011 | |
| Moderate | 9 (0.6) | 8 (0.5) | 1.000 | |
| Severe | 3 (0.2) | 2 (0.1) | 1.000 | |
| Missing | 0 | 0 | – | |
| IPF | Total | 20 (1.3) | 14 (0.9) | 0.377 |
| Mild | 0 | 0 | – | |
| Moderate | 1 (0.1) | 3 (0.2) | 0.500 | |
| Severe | 2 (0.1) | 9 (0.6) | 0.065 | |
| Missing | 17 (1.1) | 2 (0.1) | < 0.001 | |
ADR adverse drug reaction, IPF idiopathic pulmonary fibrosis, MedDRA Medical Dictionary for Regulatory Activities, PT preferred term
aMcNemar's test for incidence pre- vs. post-dose reduction