TABLE 3.
Overall summary of adverse events leading to discontinuation of study drug
| Safety outcomes, n (%) | Berotralstat | Berotralstat | Total (N = 227) |
|---|---|---|---|
| 110 mg (n = 100) | 150 mg (n = 127) | ||
| AEs leading to discontinuation of study drug a | 6 (6) | 13 (10) | 19 (8) |
| AEs or laboratory abnormalities leading to discontinuation of study drug (>1 patient in any treatment group) | |||
| Liver‐related abnormalities | 3 (3) | 5 (4) | 8 (4) |
| Upper abdominal pain | 2 (2) | 1 (1) | 3 (1) |
| Vomiting | 0 (0) | 2 (2) | 2 (1) |
Abbreviation: AE, adverse event.
Berotralstat 110 mg (n = number of patients): Alanine aminotransferase and aspartate aminotransferase increased (n = 1), hepatic enzyme increased and drug eruption and gastroenteritis (n = 1), liver function test abnormal (n = 1), abdominal pain upper (n = 2), headache (n = 1). Berotralstat 150 mg (n = number of patients): Alanine aminotransferase increased (n = 1), alanine aminotransferase and aspartate aminotransferase increased (n = 1), hepatic enzyme increased (n = 1), liver function test abnormal (n = 1), abdominal pain upper (n = 1), vomiting (n = 1), diarrhea and alanine aminotransferase increased (n = 1), vomiting and nausea (n = 1), dermatitis psoriasiform and rash (n = 1), anemia (n = 1), arthralgia, myalgia, and dizziness (n = 1), acute myelomonocytic leukemia (n = 1), depression and suicide attempt (n = 1). Patients may have experienced the same coded event more than once.