Treatment related adverse events by maximum grade per patient

Adverse eventGrade 1Grade 2Grade 3Grade 4
Hematological
 Lymphopenia1230
 Anemia2120
 Thrombocytopenia2000
 Neutropenia1100
Gastrointestinal
 Anorexia2010
 Nausea5000
 Vomit3000
 Diarrhea5000
 GERD0100
 Dyspepsia1100
Endocrinology and Chemistry
 Increased creatinine1210
 Hypothyroidism1100
 Proteinuria1000
 Increase ALT/AST4000
 Increase Alkaline Phosphatase2000
Cardiovascular
 Hypertension0310
 Syncope001a0
 DVT01b00
Other
 Fatigue6200
 Dyspnea1000
 Headache1000
 Arthralgia2000
 Dizziness2000
 Gastric hemorrhage0100
 Hoarseness1000

Anemia occurred in 5 of 9 patients, one with grade 3 anemia required olaparib dose reduction. One patient was taken off study treatment for extensive progression of disease after 3 cycles of treatment and developed multifactorial causes for renal failure, grade 3 creatinine elevation and grade 3 anemia at the time. This patient also developed a new-onset DVT in lower extremity after cycle 3 of treatment, thus cediranib was discontinued but other two drugs were continued

Abbreviations: GERD gastroesophageal reflux disease, AST aspartate aminotransferase, ALT alanine aminotransferase, DVT deep venous thrombosis

aUnlikely related to study drugs – determined to be a non-drug related vasovagal episode after extensive cardiovascular investigation including brain imaging

bPossibly related to cediranib and disease, cediranib was discontinued after grade 2 DVT event but durvalumab and olaparib were continued