Management of AEs
PD
HYPERSENSITIVITY
If AEs occurred and were deemed to be related to nintedanib by the investigator, treatment was interrupted to facilitate resolution. The dose of nintedanib was then restarted at the lower dose of either 150 mg BID or 100 mg BID. AEs that were deemed to be related to docetaxel were managed conservatively where possible between doses of docetaxel. Patients were permitted to receive treatment for symptomatic side effects such as a decreased neutrophil count, for which granulocyte colony-stimulating factor could be administered at the investigator’s discretion. Treatment was discontinued in patients who had PD, significant protocol deviations, or were unable to complete docetaxel infusions for reasons such as infusion-related hypersensitivity. Patients who experienced radiological progression according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 but were judged by the investigator to have derived clinical benefit could remain in the study if appropriate following discussion with the sponsor.