Safety profile
nausea, pneumonia, diarrhea, febrile neutropenia, toxicity, vomiting, SAEs
CARDIAC FAILURE, DISEASE PROGRESSION, PNEUMONIA, FEBRILE NEUTROPENIA, ADVERSE EVENTS, ADVERSE EVENT
All 30 patients receiving at least one dose of nintedanib/placebo were evaluated for safety. No AEs occurred before treatment start. A summary of AEs occurring in at least three patients (10%) and all serious AEs (SAE) are shown in Table Adverse events occurring in at least 10% of patients and all serious adverse eventsA total of 281 AEs were reported, 162 in the nintedanib arm (58%) and 119 in the placebo arm (42%). These were coded as 286 MedDRA codes (nintedanib: 165/286, 58%; placebo: 121/286, 42%). Ninety-nine AEs were deemed related to study treatment (nintedanib: 71/162 (44%); placebo: 28/119 (24%)). All patients had at least one AE with a median (range) frequency of 6.5 AEs (1–57). Most commonly, and in line with the known toxicity profile of nintedanib, patients experienced diarrhea (nintedanib: 7; placebo: 5), nausea (nintedanib: 7; placebo: 4) and vomiting (nintedanib: 8; placebo: 0). In 8 patients, AEs led to temporary treatment interruptions (nintedanib: 5; placebo: 3). AEs leading to study discontinuation were reported in 10 patients (nintedanib: 5 (4 infection-related, 1 diarrhea); placebo: 5 (2 disease progression, 1 infection-related, 1 infection-related with cardiac failure, 1 general physical health deterioration)).A total of 45 SAEs occurred (nintedanib: 24; placebo: 21) in 21 patients (nintedanib: 9; placebo: 12), which were coded as 48 MedDRA codes. Thirteen SAEs were deemed related to study treatment (nintedanib: 9; placebo: 4). Most frequently, febrile neutropenia occurred in 7 patients (nintedanib: 2; placebo: 5) and pneumonia in 4 patients (nintedanib: 2; placebo: 2). SAEs led to temporary treatment interruption in 7 patients (nintedanib: 4; placebo: 3) and to study discontinuation in 9 patients (nintedanib: 4; placebo: 5). Nine patients died due to SAEs (nintedanib: 3 (all infection-related); placebo: 6 (3 infection-related issues, 2 disease progression and 1 general physical health deterioration)).No statistically noticeable differences (Adverse events. Butterfly plot displaying the percentage of patients with at least one AE or with at least one AE of CTCAE grade ≥ 3 by system organ class