Table 2.
Most frequent TEAEs related to study treatment by maximum CTCAE grade categories
Adverse events | Crenigacestat 25 mg (n = 4) | Crenigacestat 50 mg (n = 7) | ||||
---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | |
Gastrointestinal disorders | 2 (50.0) | 0 | 0 | 1 (14.3) | 2 (28.6) | 0 |
Diarrhoea | 1 (25.0) | 0 | 0 | 2 (28.6) | 0 | 0 |
Vomiting | 1 (25.0) | 0 | 0 | 1 (14.3) | 0 | 0 |
Nausea | 0 | 0 | 0 | 1 (14.3) | 2 (28.6) | 0 |
Malaise | 1 (25.0) | 0 | 0 | 1 (14.3) | 0 | 0 |
Metabolism and nutrition disorders | 0 | 0 | 0 | 0 | 2 (28.6) | 2 (28.6) |
Decreased appetite | 0 | 0 | 0 | 1 (14.3) | 2 (28.6) | 0 |
Hypophosphataemia | 0 | 0 | 0 | 0 | 0 | 2 (28.6) |
Hepatic enzyme increased | 0 | 0 | 1 (25.0) | 0 | 0 | 0 |
Eye disorders | 1 (25.0) | 0 | 0 | 0 | 0 | 0 |
Visual impairment | 1 (25.0) | 0 | 0 | 0 | 0 | 0 |
Skin and subcutaneous tissue disorders | 0 | 0 | 0 | 2 (28.6) | 0 | 0 |
Rash | 0 | 0 | 0 | 1 (14.3) | 0 | 0 |
Alopecia | 0 | 0 | 0 | 1 (14.3) | 0 | 0 |
Hair color changes | 0 | 0 | 0 | 1 (14.3) | 0 | 0 |
Data reported as n (%). Adverse events were coded using MedDRA terms (Version 22.0)
Abbreviations: CTCAE Common Terminology Criteria for Adverse Events, MedDRA Medical Dictionary for Regulatory Activites, n number of patients