TABLE 2.

Intention-to-treat Poisson regression analysis for outcomes identified from inpatient diagnosis.

Intention-to-treat (ITT)	Within 30 days after index date				Within 180 days after index date				Within 365 days after index date
	Event (N)	Follow-up (Day)	cIRR (95% CI)	aIRR (95% CI)§	Event (N)	Follow-up (Day)	cIRR (95% CI)	aIRR (95% CI)§	Event (N)	Follow-up (Day)	cIRR (95% CI)	aIRR (95% CI)§
Inpatient DILI (specific codes)
Nintedanib	7	40259	NA	NA	27	222827	2.19 (0.66-7.22)	2.68 (0.80-8.94)	39	419882	3.21 (0.99-10.38)	3.62 (1.11-11.78)*
Pirfenidone	<3	9570	Ref.	Ref.	3	54242	Ref.	Ref.	3	103584	Ref.	Ref.
Inpatient DILI (nonspecific codes)
Nintedanib	9	40243	NA	NA	36	222165	2.93 (0.90-9.51)	3.33 (1.02-10.87)*	52	418032	3.22 (1.16-8.89)*	3.50 (1.26-9.72)*
Pirfenidone	<3	9570	Ref.	Ref.	3	54242	Ref.	Ref.	4	103401	Ref.	Ref.
Inpatient liver cancer
Nintedanib	5	40295	1.19 (0.14-10.14)	0.74 (0.06-8.90)	16	223688	0.96 (0.32-2.88)	1.25 (0.35-4.41)	19	422938	0.92 (0.34-2.47)	1.40 (0.43-4.51)
Pirfenidone	<3	9551	Ref.	Ref.	4	53822	Ref.	Ref.	5	102499	Ref.	Ref.
Inpatient fall (negative outcome)
Nintedanib	<3	40346	NA	NA	8	224324	0.96 (0.20-4.54)	0.93 (0.19-4.46)	17	423392	0.82 (0.30-2.23)	0.83 (0.30-2.27)
Pirfenidone	<3	9570	Ref.	Ref.	<3	54010	Ref.	Ref.	5	102538	Ref.	Ref.

^*< 0.05.

^§Adjusted variables: gender, age group, comorbidity (hepatitis B, hepatitis C, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, alcoholic liver disease, biliary disease, liver cancer, liver cirrhosis, Epstein–Barr virus disease, and autoimmune hepatitis), and comedication (antibiotics, nonsteroidal anti-inflammatory drugs, statins, proton pump inhibitors).