TABLE 2.
Overview of treatment-emergent adverse events (TEAEs)
| Deupirfenidone (n=95) | Placebo (n=90) | |
|---|---|---|
| Patients with ≥1 TEAE | 71 (74.7) | 43 (47.8) |
| Drug-related TEAEs | 38 (40.0) | 18 (20.0) |
| TEAEs by severity | ||
| Grade 1 (mild) | 38 (40.0) | 25 (27.8) |
| Grade 2 (moderate) | 23 (24.2) | 14 (15.6) |
| Grade 3 (severe) | 10 (10.5) | 3 (3.3) |
| Grade 4 (life-threatening) | 0 | 0 |
| Grade 5 (death) | 0 | 1 (1.1) |
| Drug-related severe TEAEs (≥grade 3) | 0 | 2 (2.2) |
| Serious TEAEs# | 3 (3.2) | 3 (3.3) |
| Drug-related serious TEAEs | 0 | 1 (1.1) |
| TEAEs leading to discontinuation¶ | 11 (11.6) | 4 (4.4) |
| TEAEs leading to dose reduction | 7 (7.4) | 2 (2.2) |
| TEAEs >5% in either arm | ||
| Nausea | 9 (9.5) | 1 (1.1) |
| Dyspepsia | 6 (6.3) | 1 (1.1) |
| Upper abdominal pain | 5 (5.3) | 2 (2.2) |
| Nasopharyngitis | 5 (5.3) | 1 (1.1) |
| Increased D-dimer | 5 (5.3) | 1 (1.1) |
| Hyperglycaemia | 3 (3.2) | 5 (5.6) |
| Headache | 5 (5.3) | 2 (2.2) |
| Cough | 5 (5.3) | 0 |
Data are presented as n (%). #: TEAEs that resulted in death, were immediately life-threatening, necessitated hospitalisation/prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity and/or resulted in a congenital abnormality/birth defect. ¶: Deupirfenidone arm: liver function test increase (n=1), pruritus (n=1), photosensitivity reaction (n=2), nail disorder (n=1), alanine aminotransferase increase (n=1), atrial fibrillation (n=1), mixed dementia (n=1), diarrhoea (n=1), dyspepsia (n=1), hepatic steatosis (n=1) and drug hypersensitivity (n=1) (note that one patient reported two of the symptoms). Placebo arm: anxiety (n=1), COVID-19 (n=1), dyspepsia (n=1) and abdominal pain (n=1).