Dose reductions and treatment interruptions in the SENSCIS trial
| Nintedanib (n=288) | Placebo (n=288) | |
| Patients with ≥1 dose reduction | 117 (40.6) | 13 (4.5) |
| Number of dose reductions per patient | ||
| 1 | 104 (36.1) | 13 (4.5) |
| 2 | 13 (4.5) | 0 |
| >2 | 0 | 0 |
| Time to first dose reduction | ||
| ≤30 days | 11 (3.8) | 2 (0.7) |
| >30 to ≤61 days | 20 (6.9) | 4 (1.4) |
| >61 to ≤91 days | 19 (6.6) | 1 (0.3) |
| >91 to ≤182 days | 34 (11.8) | 4 (1.4) |
| >182 days | 33 (11.5) | 2 (0.7) |
| Patients with ≥1 dose re-escalation following dose reduction | 25 (8.7) | 2 (0.7) |
| Patients for whom last dose was 100 mg two times per day | 105 (36.5) | 11 (3.8) |
| Most frequent reasons for dose reduction, n (%) of dose reductions* | ||
| Adverse events considered related to trial drug by investigator | ||
| Diarrhoea | 77 (59.2) | 4 (30.8) |
| Vomiting | 7 (5.4) | 0 (0.0) |
| Alanine aminotransferase increased | 5 (3.8) | 0 (0.0) |
| Nausea | 5 (3.8) | 0 (0.0) |
| Hepatic enzyme increased | 4 (3.1) | 1 (7.7) |
| Abdominal pain upper | 3 (2.3) | 1 (7.7) |
| Weight decreased | 3 (2.3) | 0 (0.0) |
| Adverse events considered unrelated to trial drug by investigator | 4 (3.1) | 0 (0.0) |
| Patients with ≥1 treatment interruption | 109 (37.8) | 33 (11.5) |
| Number of treatment interruptions per patient | ||
| 1 | 73 (25.3) | 24 (8.3) |
| 2 | 21 (7.3) | 3 (1.0) |
| >2 | 15 (5.2) | 6 (2.1) |
| Time to first treatment interruption | ||
| ≤30 days | 18 (6.3) | 8 (2.8) |
| >30 to ≤61 days | 18 (6.3) | 6 (2.1) |
| >61 to ≤91 days | 19 (6.6) | 6 (2.1) |
| >91 to ≤182 days | 29 (10.1) | 3 (1.0) |
| >182 days | 25 (8.7) | 10 (3.5) |
| Duration of treatment interruption (days), mean (SD)† | 23.1 (17.4) | 19.7 (19.8) |
| Most frequent reasons for treatment interruption, n (%) of interruptions* | ||
| Adverse events considered related to trial drug by investigator | ||
| Diarrhoea | 75 (41.2) | 12 (19.4) |
| Abdominal pain upper | 19 (10.4) | 6 (9.7) |
| Alanine aminotranferase increased | 5 (2.7) | 1 (1.6) |
| Hepatic enzyme increased | 5 (2.7) | 1 (1.6) |
| Vomiting | 4 (2.2) | 1 (1.6) |
| Hypotension | 0 (0.0) | 3 (4.8) |
| Adverse events considered unrelated to trial drug by investigator | 19 (10.4) | 15 (24.2) |
Data are n (%) of patients unless otherwise stated. Dose reductions and treatment interruptions over 52 weeks are shown.
*Reasons reported in >2 patients in either treatment group are shown based on preferred terms in the Medical Dictionary for Regulatory Activities.
†Total duration of all interruptions.