Safety & Tolerability in the SOLO-1 Trial

Primary analysis: Adverse Reactions (ARs) reported in ≥10% of women on LYNPARZA vs placebo

  • LYNPARZA (n=260)
  • Placebo (n=130)
Adverse reactions* Grades 1–4 (%) Grades 3–4 (%)
Fatigue†
  • 67
  • 42
  • 4
  • 2
Anemia
  • 38
  • 9
  • 21
  • 2
Neutropenia‡
  • 17
  • 7
  • 6
  • 3
Leukopenia§
  • 13
  • 8
  • 3
  • 0
Thrombocytopenia||
  • 11
  • 4
  • 1
  • 2
Nausea
  • 77
  • 38
  • 1
  • 0
Vomiting
  • 40
  • 15
  • 0
  • 1
Abdominal pain
  • 45
  • 35
  • 2
  • 1
Diarrhea#
  • 37
  • 26
  • 3
  • 0
Dyspepsia
  • 17
  • 12
  • 0
  • 0
Constipation
  • 28
  • 19
  • 0
  • 0
Stomatitis**
  • 11
  • 2
  • 0
  • 0
Upper respiratory tract infection/influenza/
nasopharyngitis/bronchitis
  • 28
  • 23
  • 0
  • 0
UTI††
  • 13
  • 7
  • 1
  • 0
Decreased appetite
  • 20
  • 10
  • 0
  • 0
Dyspnea‡‡
  • 15
  • 6
  • 0
  • 0
Dysgeusia
  • 26
  • 4
  • 0
  • 0
Dizziness
  • 20
  • 15
  • 0
  • 1
  • *Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.1
  • †Includes asthenia, fatigue, lethargy, malaise.1
  • ‡Includes neutropenia, febrile neutropenia.1
  • §Includes leukopenia, white blood cell count decreased.1
  • IIIncludes platelet count decreased, thrombocytopenia.1
  • Includes abdominal pain, abdominal pain lower, abdominal pain upper, abdominal distension, abdominal discomfort, abdominal tenderness.1
  • #Includes colitis, diarrhea, gastroenteritis.1
  • **Includes stomatitis, aphthous ulcer, mouth ulceration.1
  • ††Includes urosepsis, urinary tract infection, urinary tract pain, pyuria.1
  • ‡‡Includes dyspnea and dyspnea exertional.1

Learn more about AR data from clinical trials

Primary analysis: Lab abnormalities reported in ≥25% of women on LYNPARZA vs placebo1

  • LYNPARZA (n=260)*
  • Placebo (n=130)*
Laboratory abnormalities† Grades 1–4 (%) Grades 3–4 (%)
Decrease in hemoglobin
  • 87
  • 63
  • 19
  • 2
Increase in mean corpuscular volume
  • 87
  • 43
  • 0
  • 0
Decrease in leukocytes
  • 70
  • 52
  • 7
  • 1
Decrease in lymphocytes
  • 67
  • 29
  • 14
  • 1
Decrease in absolute neutrophil count
  • 51
  • 38
  • 9
  • 6
Increase in serum creatinine
  • 34
  • 18
  • 0
  • 0
Decrease in platelets
  • 35
  • 20
  • 1
  • 2
  • *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.
  • †Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.

Monitor patients for hematological toxicity at baseline and monthly thereafter.

At 7-year follow-up analysis

  • No new safety signals were identified2
  • 4 (1.5%) cases of MDS/AML were reported in the LYNPARZA group and 1 (0.8%) case was reported in the placebo group; 14 (5.4%) cases of new primary malignancies were reported in the LYNPARZA group and 8 (6.2%) cases were reported in the placebo group; 5 (1.9%) cases of pneumonitis were reported in the LYNPARZA group and none were reported in the placebo group2,3
  • Safety profile remained consistent with the primary analysis and DCO22

AML=acute myeloid leukemia; MDS=myelodysplastic syndrome.

At 7-year follow-up analysis

  • No new safety signals were identified2
  • 4 (1.5%) cases of MDS/AML were reported in the LYNPARZA group and 1 (0.8%) case was reported in the placebo group; 14 (5.4%) cases of new primary malignancies were reported in the LYNPARZA group and 8 (6.2%) cases were reported in the placebo group; 5 (1.9%) cases of pneumonitis were reported in the LYNPARZA group and none were reported in the placebo group2,3
  • Safety profile remained consistent with the primary analysis and DCO22

AML=acute myeloid leukemia; MDS=myelodysplastic syndrome.

IMPORTANT SAFETY INFORMATION