Table 4.

AEs that were reported for more than 1 patient

System organ class/preferred term	Nintedanib 200 mg with docetaxel 75 mg/m2
	All grades N (%)	Grade 3/4 N (%)
Number of patients	10 (100.0)	10 (100.0)
Total with any AEs	10 (100.0)	10 (100.0)
Blood and lymphatic system disorders	2 (20.0)	2 (20.0)
Febrile neutropenia	2 (20.0)	2 (20.0)
Eye disorders	5 (50.0)	0 (0.0)
Lacrimation increased	2 (20.0)	0 (0.0)
Gastrointestinal disorders	9 (90.0)	0 (0.0)
Constipation	5 (50.0)	0 (0.0)
Diarrhea	5 (50.0)	0 (0.0)
Nausea	5 (50.0)	0 (0.0)
Vomiting	2 (20.0)	0 (0.0)
General disorders and administration-site conditions	8 (80.0)	0 (0.0)
Fatigue	4 (40.0)	0 (0.0)
Edema peripheral	3 (30.0)	0 (0.0)
Pyrexia	3 (30.0)	0 (0.0)
Malaise	2 (20.0)	0 (0.0)
Infections and infestations	6 (60.0)	0 (0.0)
Cystitis	2 (20.0)	0 (0.0)
Upper respiratory tract infection	2 (20.0)	0 (0.0)
Investigations	10 (100.0)	10 (100.0)
Neutrophil count decreased	10 (100.0)	10 (100.0)
WBC count decreased	10 (100.0)	10 (100.0)
ALT increased	8 (80.0)	3 (30.0)
AST increased	7 (70.0)	3 (30.0)
GGT increased	4 (40.0)	2 (20.0)
Blood alkaline phosphatase increased	2 (20.0)	0 (0.0)
Hemoglobin decreased	2 (20.0)	0 (0.0)
Lymphocyte count decreased	2 (20.0)	2 (20.0)
Metabolism and nutrition disorders	4 (40.0)	1 (10.0)
Decreased appetite	4 (40.0)	0 (0.0)
Musculoskeletal and connective tissue disorders	2 (20.0)	0 (0.0)
Myalgia	2 (20.0)	0 (0.0)
Nervous system disorders	5 (50.0)	0 (0.0)
Peripheral sensory neuropathy	4 (40.0)	0 (0.0)
Dysgeusia	3 (30.0)	0 (0.0)
Headache	2 (20.0)	0 (0.0)
Psychiatric disorders	3 (30.0)	0 (0.0)
Insomnia	3 (30.0)	0 (0.0)
Skin and subcutaneous tissue disorders	9 (90.0)	0 (0.0)
Alopecia	9 (90.0)	0 (0.0)
Palmar–Plantar erythrodysesthesia syndrome	2 (20.0)	0 (0.0)
Pruritus	2 (20.0)	0 (0.0)
Rash	2 (20.0)	0 (0.0)
Vascular disorders	4 (40.0)	1 (10.0)
Flushing	2 (20.0)	0 (0.0)

AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, GGT gamma-glutamyltransferase, WBC white blood cell