Table 1

Dose reductions and treatment interruptions in the SENSCIS trial

Nintedanib (n=288)Placebo (n=288)
Patients with ≥1 dose reduction117 (40.6)13 (4.5)
Number of dose reductions per patient
 1104 (36.1)13 (4.5)
 213 (4.5)0
 >200
Time to first dose reduction
 ≤30 days11 (3.8)2 (0.7)
 >30 to ≤61 days20 (6.9)4 (1.4)
 >61 to ≤91 days19 (6.6)1 (0.3)
 >91 to ≤182 days34 (11.8)4 (1.4)
 >182 days33 (11.5)2 (0.7)
Patients with ≥1 dose re-escalation following dose reduction25 (8.7)2 (0.7)
Patients for whom last dose was 100 mg two times per day105 (36.5)11 (3.8)
Most frequent reasons for dose reduction, n (%) of dose reductions*
 Adverse events considered related to trial drug by investigator
  Diarrhoea77 (59.2)4 (30.8)
  Vomiting7 (5.4)0 (0.0)
  Alanine aminotransferase increased5 (3.8)0 (0.0)
  Nausea5 (3.8)0 (0.0)
  Hepatic enzyme increased4 (3.1)1 (7.7)
  Abdominal pain upper3 (2.3)1 (7.7)
  Weight decreased3 (2.3)0 (0.0)
 Adverse events considered unrelated to trial drug by investigator4 (3.1)0 (0.0)
Patients with ≥1 treatment interruption109 (37.8)33 (11.5)
Number of treatment interruptions per patient
 173 (25.3)24 (8.3)
 221 (7.3)3 (1.0)
 >215 (5.2)6 (2.1)
Time to first treatment interruption
 ≤30 days18 (6.3)8 (2.8)
 >30 to ≤61 days18 (6.3)6 (2.1)
 >61 to ≤91 days19 (6.6)6 (2.1)
 >91 to ≤182 days29 (10.1)3 (1.0)
 >182 days25 (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
  Diarrhoea75 (41.2)12 (19.4)
  Abdominal pain upper19 (10.4)6 (9.7)
  Alanine aminotranferase increased5 (2.7)1 (1.6)
  Hepatic enzyme increased5 (2.7)1 (1.6)
  Vomiting4 (2.2)1 (1.6)
  Hypotension0 (0.0)3 (4.8)
 Adverse events considered unrelated to trial drug by investigator19 (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.