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. Author manuscript; available in PMC: 2021 Feb 15.
Published in final edited form as: Clin Cancer Res. 2020 May 12;26(16):4268–4279. doi: 10.1158/1078-0432.CCR-20-0056

Table 2.

Treatment-related adverse events by maximum grade per patient

Adverse Events Grade 1 Grade 2 Grade 3 Grade 4
Hematological
 Anemia* 9 (26%) 11 (31%) 11 (31%) 0
 Decreased platelets 9 (26%) 0 0 0
 Decreased leukocytes 7 (20%) 4 (11%) 1 (3%) 0
 Decreased lymphocytes 4 (11%) 14 (40%) 7 (20%) 0
 Decreased neutrophils 0 3 (9%) 1 (3%) 0
Gastrointestinal
 Nausea 16 (46%) 1 (3%) 0 0
 Vomit 12 (34%) 0 0 0
 Diarrhea 8 (23%) 1 (3%) 0 0
 Constipation 4 (11%) 0 0 0
 GERD 5 (14%) 0 0 0
 Anorexia 8 (23%) 1 (3%) 0 0
 Proctitis 0 1 (3%) 0 0
Endocrinology and Chemistry
 Hypothyroidism 1 (3%) 0 0 0
 Hyperthyroidism 2 (6%) 0 0 0
 Increased creatinine 7 (20%) 4 (11%) 0 0
 Increased ALT/AST 3 (9%) 0 0 0
Dermatological
 Rash 2 (6%) 1 (3%) 1 (3%) 0
 Hyperpigmentation 2 (6%) 0 0 0
 Erythema multiforme 1 (3%) 0 0 0
Other
 Fatigue 14 (40%) 5 (14%) 0 0
 Headache 2 (6%) 0 0 0
 Insomnia 1 (3%) 0 0 0
 Arthralgia 2 (6%) 0 0 0
 Myalgia 1 (3%) 0 0 0
 Weight loss 1 (3%) 0 0 0
 Weight gain 1 (3%) 0 0 0
 Dry eye 1 (3%) 0 0 0
 Dry mouth 1 (3%) 0 0 0
 Flushing** 1 (3%) 0 0 0
*

Three patients required olaparib dose reduction because of recurrent anemia. No one had durvalumab dose reduction or discontinuation due to adverse events. No treatment related deaths were recorded.

**

During durvalumab infusion

Abbreviations: GERD = gastroesophageal reflux disease, ALT = alanine aminotransferase, AST = aspartate aminotransferase