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. 2020 Sep 16;39(2):469–476. doi: 10.1007/s10637-020-01001-5

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