Table 3.
Events, n | Placebo | Avagacestat | Placebo | Avagacestat | Total placebo (n= 9) | Total Avagacestat (n= 27) | ||
---|---|---|---|---|---|---|---|---|
18–59 years (n= 4) | 18–45 years (n= 6) | 46–59 years (n= 6) | ≥60 years (n= 5) | 60–74 years (n= 6) | ≥75 years (n= 9) | |||
Total subjects with AEs | 1 | 2 | 1 | 4 | 3 | 6 | 5 | 12 |
Total AEs | 2 | 2 | 1 | 9 | 4 | 6 | 11 | 13 |
System organ class preferred term | ||||||||
General disorders and administration site conditions | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Gastrointestinal disorders | ||||||||
Constipation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Infections and infestations | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 |
Investigations (increases in ALT, AST, blood CPK and LDH, and transaminases); occult blood positive | 2 | 2 | 0 | 0 | 0 | 0 | 2 | 2 |
Muscoskeletal and connective tissue disorders | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Nervous system disorders | ||||||||
Dizziness | 0 | 0 | 1 | 2 | 1 | 0 | 2 | 2 |
Headache | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Haemorrhagic stroke | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
Paresthesia | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
Renal and urinary disorders | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 |
Skin and subcutaneous tissue disorders | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
Unspecified | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Vascular disorders | 0 | 0 | 0 | 2 | 2 | 0 | 2 | 2 |
AEs, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; LDH, lactate dehydrogenase.