Table 5 Selected treatment emergent adverse events (TEAE, Safety population = 39 patients) in Cohort B (HR+ HER2+, no fulvestrant).
% Any TEAE (95% CI) | % Grade 3 TEAE (95% CI) | ||
|---|---|---|---|
Neutropenia | 64.1 (47.2−78.8) | 30.8 (17.0−47.6) | |
Diarrhea | 59.0 (42.1−74.4) | 7.7 (1.6−20.9) | |
Mucosal inflammation | 33.3 (19.1−50.2) | − | |
Pyrexia | 28.2 (15.0−44.9) | − | |
Stomatitis | 28.2 (15.0−44.9) | 5.1 (0.6−17.3) | |
Asthenia | 20.5 (9.3−36.5) | − | |
Fatigue | 20.5 (9.3−36.5) | − | |
Nausea | 17.9 (7.5−33.5) | − | |
Epistaxis | 17.9 (7.5−33.5) | − | |
Rash | 17.9 (7.5−33.5) | − | |
Vomiting | 15.4 (5.9−30.5) | − | |
Anemia | 12.8 (4.3−27.4) | − | |
Leukopenia | 12.8 (4.3−27.4) | 5.1 (0.6−17.3) | |
Folliculitis | 10.3 (2.9−24.2) | − | |
Hemorrhoids | 10.3 (2.9−24.2) | − | |
ALT increased | 7.7 (1.6−20.9) | 2.6 (0.1−13.5) | |
AST | 7.7 (1.6−20.9) | − | |
