Table 2.
Overview of ADRs
| Pirfenidone (N = 1620) | |
|---|---|
| ADRs, n (%) | |
| Patients with ≥1 ADR | 1051 (64.9) |
| ADRs with >5% incidence | |
| Nausea | 366 (22.6) |
| Fatigue | 317 (19.6) |
| Diarrhea | 182 (11.2) |
| Rash | 133 (8.2) |
| Anorexia | 116 (7.2) |
| Dyspepsia | 112 (6.9) |
| Dizziness | 99 (6.1) |
| Decreased appetite | 95 (5.9) |
| Gastroesophageal reflux disease | 88 (5.4) |
| ADR resulting in death | 0 |
| ADR leading to dose modification or interruption | 377 (23.3) |
| ADR leading to discontinuation of pirfenidone | 210 (13.0) |
| SADRs, n (%)a | |
| Patients with ≥1 SADR | 24 (1.5) |
| SADRs in ≥2 patients | |
| ALT elevatedb | 5 (0.3) |
| Hepatic enzyme elevatedc | 5 (0.3) |
| AST elevatedb | 2 (0.1) |
| Diarrhea | 2 (0.1) |
| Nausea | 2 (0.1) |
| SADR resulting in death | 0 |
| SADR leading to dose modification or interruption | 5 (0.3) |
| SADR leading to discontinuation of pirfenidone | 17 (1.0) |
ADR adverse drug reaction, ALT alanine aminotransferase, AST aspartate aminotransferase, LFT liver function test, SADR serious adverse drug reaction, ULN upper limit of normal
aSADR is defined as a serious adverse event deemed to be causally related to pirfenidone
bTwo patients had both elevated ALT and AST levels
cPreferred Term used for events not coded to other Preferred Terms; these included the following investigator-specified verbatim terms: elevated AST and ALT, elevated AST/ALT, elevated LFTs >5 ULN, elevated liver enzymes, high ALT/AST, increased ALT and AST, increased ALT and AST labs, and increased liver enzymes