TABLE 5.
Per-protocol Poisson regression analysis for outcomes identified from outpatient and inpatient diagnosis.
| Per-protocol (PP) | 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)§ | |
| Outpatient/inpatient DILI (specific codes) | ||||||||||||
| Nintedanib | 17 | 40184 | 4.04 (0.54-30.35) | 4.01 (0.53-30.37) | 45 | 218772 | 1.83 (0.78-4.28) | 1.99 (0.84-4.72) | 59 | 405162 | 2.41 (1.04–5.58)* | 2.54 (1.09–5.91)* |
| Pirfenidone | <3 | 9547 | Ref. | Ref. | 6 | 53249 | Ref. | Ref. | 6 | 99288 | Ref. | Ref. |
| Outpatient/inpatient DILI (nonspecific codes) | ||||||||||||
| Nintedanib | 23 | 40092 | 1.09 (0.41-2.86) | 1.02 (0.38-2.73) | 65 | 216687 | 1.43 (0.76-2.71) | 1.48 (0.77-2.83) | 85 | 399752 | 1.60 (0.89-2.86) | 1.63 (0.90-2.93) |
| Pirfenidone | 5 | 9472 | Ref. | Ref. | 11 | 52521 | Ref. | Ref. | 13 | 97549 | Ref. | Ref. |
| Outpatient/inpatient liver cancer | ||||||||||||
| Nintedanib | 18 | 40104 | 0.85 (0.32-2.29) | 1.14 (0.29-4.51) | 25 | 220382 | 1.00 (0.41-2.43) | 1.19 (0.41-3.48) | 26 | 410336 | 0.89 (0.39-2.05) | 1.01 (0.37-2.71) |
| Pirfenidone | 5 | 9483 | Ref. | Ref. | 6 | 52718 | Ref. | Ref. | 7 | 98092 | Ref. | Ref. |
| Outpatient/inpatient fall (negative outcome) | ||||||||||||
| Nintedanib | <3 | 40346 | NA | NA | 10 | 222448 | 0.72 (0.19-2.65) | 0.69 (0.19-2.60) | 20 | 413148 | 0.68 (0.29-1.61) | 0.67 (0.28-1.59) |
| Pirfenidone | <3 | 9570 | Ref. | Ref. | 3 | 53293 | Ref. | Ref. | 7 | 98694 | 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).