Safety & Tolerability in the OlympiAD Trial1

In OlympiAD

Adverse Reactions (ARs) reported in ≥20% of patients1*

  • LYNPARZA (n=205)
  • HCP's choice of chemotherapy (n=91)
Adverse reactions Grades 1–4 (%) Grades 3–4 (%)
Anemia
  • 40
  • 26
  • 16
  • 4
Leukopenia§
  • 25
  • 31
  • 5
  • 13
Neutropenia||
  • 27
  • 50
  • 9
  • 26
Nausea
  • 58
  • 35
  • 0
  • 1
Vomiting
  • 30
  • 15
  • 0
  • 1
Diarrhea
  • 21
  • 22
  • 1
  • 0
Respiratory tract infection
  • 27
  • 22
  • 1
  • 0
Fatigue (including asthenia)
  • 37
  • 36
  • 4
  • 1
Headache
  • 20
  • 15
  • 1
  • 2

ARs in OlympiAD that occurred in <20% of patients receiving LYNPARZA were cough (18%), decreased appetite (16%), thrombocytopenia (11%), dysgeusia (9%), lymphopenia (8%), dyspepsia (8%), dizziness (7%), stomatitis (7%), upper abdominal pain (7%), rash (5%), increase in serum creatinine (3%), and dermatitis (1%).1

  • *Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
  • HCP’s choice of chemotherapy (capecitabine, eribulin, or vinorelbine).1
  • Represents grouped terms consisting of anemia (anemia erythropenia, hematocrit decreased, hemoglobin decreased, and red blood cell count decreased).
  • §Represents grouped terms consisting of leukopenia and white blood cell count decreased.
  • ||Represents grouped terms consisting of neutropenia (febrile neutropenia, granulocyte count decreased, granulocytopenia, neutropenia, neutropenic infection, neutropenic sepsis, and neutrophil count decreased).
  • Represents grouped terms consisting of bronchitis, influenza, lower respiratory tract infection, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis, upper respiratory tract infection, and upper respiratory tract infection bacterial.

Learn about median onset and duration of ARs in clinical trials

Lab abnormalities reported in ≥25% of patients1

  • LYNPARZA (n=205)*
  • HCP's choice of chemotherapy (n=91)*
Laboratory parameter Grades 1–4 (%) Grades 3–4 (%)
Increase in mean corpuscular volumes§
  • 71
  • 33
  • 0
  • 0
Decrease in hemoglobin
  • 82
  • 66
  • 17
  • 3
Decrease in leukocytes
  • 71
  • 70
  • 8
  • 23
Decrease in lymphocytes
  • 73
  • 63
  • 21
  • 3
Decrease in absolute neutrophil count
  • 46
  • 65
  • 11
  • 38
Decrease in platelets
  • 33
  • 28
  • 3
  • 0
  • *This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.
  • HCP’s choice of chemotherapy (capecitabine, eribulin, or vinorelbine).1
  • Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.
  • §Represents the proportion of subjects whose mean corpuscular volume was >ULN.

AR=adverse reaction; HCP=healthcare professional; HER2‐negative=human epidermal growth factor receptor 2-negative; ULN=upper limit of normal.

IMPORTANT SAFETY INFORMATION