Phase I/II Safety
cognitive disorder, anemia, TRAEs, gastroesophageal reflux disease
ADVERSE EVENTS, ADVERSE EVENT, ANEMIA
 The median treatment duration of avapritinib in both dose groups was 36.0 weeks (range = 2.0-72.0 weeks). Among the 65 patients, 30 (50.8%), all from the 300-mg group, had a dose reduction; and 56 (86.2%) patients had a dose interruption. TEAEs leading to study drug discontinuation occurred in 3/65 (5%) patients (Summary of treatment-related adverse events
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; GERD, gastroesophageal reflux disease; TRAE, treatment-related adverse event.Summary of treatment-emergent adverse events (safety analysis set)Data are shown as Abbreviations: AESI, adverse event of special interest; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.TEAEs were defined as any adverse event that occurred or worsened on or after the initiation of the study drug. For frequency counts by System Organ Class or Preferred Term, multiple occurrences of the same condition in an individual were counted only once.Serious TEAEs were observed in 4/6 (67%) patients in the 200-mg dose group and 28/59 (48%) patients in the 300-mg dose group. Serious TRAEs were reported in 15/65 (23%) patients in total. The most commonly occurring serious TRAEs at any dose were anemia (7/65; 11%) and cognitive disorder (3/65; 5%) (Serious treatment-related adverse events and adverse events of special interest (safety analysis set)Abbreviations: AESI, adverse event of special interest; TRAE, treatment-related adverse event.AESIs are shown by category and then by the Medical Dictionary for Regulatory Activities Preferred Term.Overall, 17/65 (26%) patients experienced at least one AE of special interest (AESI), all of which occurred in the 300-mg dose group (