Table 4.

Exposure and Adverse Events by Subgroup

	Honeycombing on HRCT and/or Confirmation of UIP by Surgical Lung Biopsy		No Honeycombing or Surgical Lung Biopsy
	Nintedanib (n = 425)	Placebo (n = 298)	Nintedanib (n = 213)	Placebo (n = 125)
Exposure, mean (SD)	10.1 (3.5)	10.7 (2.9)	10.7 (3.0)	11.1 (2.6)
Any adverse event(s)	407 (95.8)	268 (89.9)	202 (94.8)	111 (88.8)
Most frequent adverse event(s)*
Diarrhea	272 (64.0)	56 (18.8)	126 (59.2)	22 (17.6)
Nausea	107 (25.2)	23 (7.7)	49 (23.0)	5 (4.0)
Nasopharyngitis	63 (14.8)	51 (17.1)	24 (11.3)	17 (13.6)
Cough	58 (13.6)	41 (13.8)	27 (12.7)	16 (12.8)
Vomiting	53 (12.5)	7 (2.3)	21 (9.9)	4 (3.2)
Decreased appetite	49 (11.5)	21 (7.0)	19 (8.9)	3 (2.4)
Bronchitis	39 (9.2)	28 (9.4)	28 (13.1)	17 (13.6)
Progression of IPF†	44 (10.4)	44 (14.8)	20 (9.4)	17 (13.6)
Weight decreased	39 (9.2)	11 (3.7)	23 (10.8)	4 (3.2)
Upper respiratory tract infection	36 (8.5)	30 (10.1)	22 (10.3)	12 (9.6)
Abdominal pain	34 (8.0)	9 (3.0)	22 (10.3)	1 (0.8)
Dyspnea	31 (7.3)	30 (10.1)	18 (8.5)	18 (14.4)
Severe adverse event(s)	115 (27.1)	72 (24.2)	59 (27.7)	27 (21.6)
Serious adverse event(s)	131 (30.8)	94 (31.5)	63 (29.6)	33 (26.4)
Fatal adverse event(s)	28 (6.6)	23 (7.7)	9 (4.2)	8 (6.4)
Adverse event(s) leading to treatment discontinuation‡	90 (21.2)	41 (13.8)	33 (15.5)	14 (11.2)
Diarrhea	19 (4.5)	1 (0.3)	9 (4.2)	0 (0.0)
Progression of IPF†	10 (2.4)	15 (5.0)	3 (1.4)	6 (4.8)
Nausea	12 (2.8)	0 (0.0)	1 (0.5)	0 (0.0)

Definition of abbreviations: HRCT = high-resolution computed tomography; IPF = idiopathic pulmonary fibrosis; UIP = usual interstitial pneumonia.

Data are n (%) for exposure.

^*Adverse events reported by >10% of patients in any treatment group.

^†Corresponds to the Medical Dictionary for Regulatory Activities term “IPF,” which included disease worsening and acute exacerbations of IPF.

^‡Adverse events leading to treatment discontinuation in >2% of patients in any treatment group.