Drug · FAERS side-effect profile with label screen
Olaparib side effects: what 20,793 FDA adverse event reports show
Drug class
Poly(ADP-Ribose) Polymerase Inhibitor
FDA label (Established Pharmacologic Class)
Brand names
Lynparza
openFDA label
Who reports
20,793 reports · 91% serious · 5,936 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
FDA label, Indications and Usage
What it is
Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 3Labeled (related wording) 3Likely indication confounding 10Reporting / coding artifact 2Lab value / disease marker 7Not in label — unassessed 15
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 981 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| High grade b-cell lymphoma burkitt-like lymphoma recurrent | 11 | 1,822.2 674.0–4,926.8ROR 1,823.2 · χ² 6,438 / p <1e-300 | 303.8 EB05 181.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Brca2 gene mutation | 23 | 317.5 198.6–507.6ROR 317.9 · χ² 5,262 / p <1e-300 | 200.9 EB05 141.0 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=23 | not reported in cached trials |
| Acute erythroid leukaemia | 14 | 296.1 163.0–537.6ROR 296.3 · χ² 2,949 / p <1e-300 | 174.4 EB05 110.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Ovarian cancer recurrent | 355 | 288.0 256.1–323.9ROR 293.0 · χ² 78,513 / p <1e-300 | 220.9 EB05 202.3 · IC025 +7.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=355 · ♀ 100% (drug 77%) | not reported in cached trials |
| Brca1 gene mutation | 16 | 224.0 130.2–385.2ROR 224.2 · χ² 2,719 / p <1e-300 | 150.5 EB05 98.2 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=16 | not reported in cached trials |
| Myelodysplastic syndrome with excess blasts | 12 | 114.7 63.1–208.4ROR 114.8 · χ² 1,113 / p 3e-244 | 88.8 EB05 54.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Carbohydrate antigen 125 increased | 300 | 96.3 85.6–108.3ROR 97.7 · χ² 25,714 / p <1e-300 | 87.4 EB05 79.4 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=273 · ♀ 99% (drug 77%) | not reported in cached trials |
| Musculoskeletal toxicity | 11 | 63.9 34.8–117.6ROR 64.0 · χ² 582 / p 5e-129 | 54.8 EB05 32.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | not reported in cached trials |
| Tumour marker abnormal | 17 | 53.8 33.0–87.7ROR 53.9 · χ² 786 / p 2e-173 | 48.5 EB05 32.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Ovarian cancer metastatic | 33 | 41.2 29.1–58.3ROR 41.2 · χ² 1,203 / p 6e-264 | 38.7 EB05 28.9 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=33 · ♀ 100% (drug 77%) | not reported in cached trials |
| Tumour marker increased | 185 | 40.3 34.8–46.6ROR 40.7 · χ² 6,777 / p <1e-300 | 38.6 EB05 34.2 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=179 | not reported in cached trials |
| Malignant peritoneal neoplasm | 22 | 38.8 25.3–59.3ROR 38.8 · χ² 743 / p 6e-164 | 36.3 EB05 25.3 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=22 | not reported in cached trials |
| Myelodysplastic syndrome | 481 | 34.6 31.7–37.9ROR 35.4 · χ² 15,161 / p <1e-300 | 33.5 EB05 31.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.3 · 93% clinician | NCT03737643: 2/378 (0.5%) on Olaparib (serious AE) |
| Metastases to peritoneum | 82 | 34.1 27.4–42.5ROR 34.2 · χ² 2,516 / p <1e-300 | 32.8 EB05 27.2 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=82 · ♀ 98% (drug 77%) | not reported in cached trials |
| Metastases to abdominal cavity | 15 | 31.5 18.9–52.7ROR 31.5 · χ² 401 / p 2e-89 | 29.5 EB05 19.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Acquired gene mutation | 40 | 31.5 23.0–43.1ROR 31.5 · χ² 1,115 / p 1e-244 | 30.2 EB05 23.1 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=40 · 92% clinician | not reported in cached trials |
| Astrocytoma | 11 | 29.1 16.0–53.0ROR 29.1 · χ² 263 / p 2e-59 | 27.0 EB05 16.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Metastases to pleura | 28 | 27.8 19.1–40.5ROR 27.9 · χ² 679 / p 6e-150 | 26.7 EB05 19.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 77%) | not reported in cached trials |
| Hormone-refractory prostate cancer | 29 | 25.5 17.7–36.9ROR 25.6 · χ² 643 / p 4e-142 | 24.6 EB05 17.9 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=29 · ♀ 0% (drug 77%) | not reported in cached trials |
| Ovarian cancer stage iv | 10 | 24.5 13.1–45.8ROR 24.5 · χ² 197 / p 4e-45 | 22.7 EB05 12.7 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Transformation to acute myeloid leukaemia | 15 | 23.5 14.1–39.2ROR 23.5 · χ² 294 / p 3e-66 | 22.3 EB05 14.2 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Metastases to pelvis | 14 | 22.8 13.5–38.8ROR 22.9 · χ² 265 / p 7e-60 | 21.7 EB05 13.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Acute myeloid leukaemia | 343 | 22.7 20.4–25.2ROR 23.1 · χ² 6,938 / p <1e-300 | 22.2 EB05 20.3 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.1 · 94% clinician | NCT02032823: 1/911 (0.1%) on Olaparib; 1/904 (0.1%) control (serious AE) |
| Myeloid leukaemia | 11 | 22.4 12.3–40.7ROR 22.4 · χ² 200 / p 1e-45 | 20.9 EB05 12.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 | NCT02032823: 1/911 (0.1%) on Olaparib; 1/904 (0.1%) control (serious AE) |
| Recurrent cancer | 85 | 21.6 17.4–26.7ROR 21.7 · χ² 1,613 / p <1e-300 | 21.1 EB05 17.6 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=85 | not reported in cached trials |
| Malignant neoplasm progression | 2,063 | 20.8 20.0–21.7ROR 23.0 · χ² 38,304 / p <1e-300 | 20.4 EB05 19.7 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 | not reported in cached trials |
| Prostatic specific antigen abnormal | 21 | 20.6 13.4–31.8ROR 20.7 · χ² 366 / p 9e-82 | 19.9 EB05 13.6 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=18 · ♀ 0% (drug 77%) | not reported in cached trials |
| Haematotoxicity | 175 | 19.4 16.7–22.5ROR 19.5 · χ² 2,976 / p <1e-300 | 19.0 EB05 16.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 96% clinician | not reported in cached trials |
| Malignant ascites | 14 | 18.7 11.0–31.8ROR 18.7 · χ² 214 / p 1e-48 | 17.7 EB05 10.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Triple negative breast cancer | 11 | 17.9 9.9–32.5ROR 17.9 · χ² 156 / p 3e-36 | 16.5 EB05 8.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Metastases to lymph nodes | 117 | 17.9 14.9–21.5ROR 18.0 · χ² 1,816 / p <1e-300 | 17.5 EB05 15.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=117 | not reported in cached trials |
| Sars-cov-2 test negative | 11 | 16.5 9.1–29.9ROR 16.5 · χ² 142 / p 4e-33 | 14.9 EB05 7.9 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=11 | not reported in cached trials |
| Acute leukaemia | 26 | 16.4 11.1–24.2ROR 16.4 · χ² 355 / p 1e-79 | 15.8 EB05 11.1 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=26 · ♀ 100% (drug 77%) · 100% clinician | NCT02032823: 1/911 (0.1%) on Olaparib; 1/904 (0.1%) control (serious AE) |
| Prostatic specific antigen increased | 208 | 15.4 13.4–17.6ROR 15.5 · χ² 2,737 / p <1e-300 | 15.1 EB05 13.5 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 14.2 · ♀ 0% (drug 77%) | not reported in cached trials |
| Pelvic mass | 12 | 15.2 8.6–26.9ROR 15.2 · χ² 143 / p 3e-33 | 13.7 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Metastases to meninges | 30 | 13.7 9.5–19.6ROR 13.7 · χ² 335 / p 4e-75 | 13.1 EB05 9.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Carbohydrate antigen 15-3 increased | 10 | 13.4 7.2–25.0ROR 13.4 · χ² 101 / p 4e-24 | 11.3 EB05 5.7 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious n=10 | not reported in cached trials |
| Red blood cell count abnormal | 19 | 13.3 8.4–20.8ROR 13.3 · χ² 200 / p 8e-46 | 12.3 EB05 7.8 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=17 | NCT02032823: 1/904 (0.1%) control (serious AE) |
| Myelosuppression | 432 | 13.0 11.8–14.2ROR 13.2 · χ² 4,701 / p <1e-300 | 12.8 EB05 11.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 93% clinician | NCT03737643: 2/378 (0.5%) on Olaparib (serious AE) |
| Metastasis | 91 | 12.9 10.5–15.9ROR 13.0 · χ² 978 / p 5e-215 | 12.7 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Olaparib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (6 of 40 signal terms matched).
- NCT02032823 — Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast C (N=1837, PHASE3; 146 AE terms posted; arms: Olaparib; Placebo)
- NCT03737643 — Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bev (N=1407, PHASE3; 473 AE terms posted; arms: Global Non-tBRCAm: SoC; Global Non-tBRCAm: SoC + Durvalumab; Global Non-tBRCAm: SoC + Durvalumab + Ol; Global tBRCAm: SoC + Durvalumab + Olapar)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 4,729 | 5.6 5.4–5.7ROR 6.9 · χ² 18,343 / p <1e-300 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.5 | not reported in cached trials |
| Malignant neoplasm progression | 2,063 | 20.8 20.0–21.7ROR 23.0 · χ² 38,304 / p <1e-300 | 20.4 EB05 19.7 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 | not reported in cached trials |
| Nausea | 1,827 | 2.3 2.2–2.4ROR 2.5 · χ² 1,449 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | NCT02032823: 1/911 (0.1%) on Olaparib (serious AE) |
| Fatigue (tiredness) | 1,762 | 2.3 2.2–2.4ROR 2.4 · χ² 1,325 / p 2e-290 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | NCT02032823: 1/911 (0.1%) on Olaparib (serious AE) |
| Anaemia (low red blood cells) | 1,622 | 8.6 8.2–9.0ROR 9.3 · χ² 10,947 / p <1e-300 | 8.6 EB05 8.2 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | NCT02032823: 15/911 (1.6%) on Olaparib; 1/904 (0.1%) control (serious AE) |
| Off label use (used outside approved label) | 934 | 1.1 1.0–1.2ROR 1.1 · χ² 6 / p 0.006 | 1.1 EB05 1.0 · IC025 +0.0 | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Vomiting | 724 | 1.6 1.5–1.7ROR 1.6 · χ² 147 / p 4e-34 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT02032823: 2/911 (0.2%) on Olaparib (serious AE) |
| Drug ineffective (drug did not work) | 677 | 0.5 0.5–0.6ROR 0.5 · χ² 323 / p 2e-72 | 0.5 EB05 0.5 · IC025 -1.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Neuropathy peripheral (nerve damage in hands/feet) | 649 | 7.0 6.5–7.5ROR 7.2 · χ² 3,300 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 74% consumer | NCT03737643: 1/378 (0.3%) on Olaparib (serious AE) |
| Diarrhoea (diarrhea) | 615 | 1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.183 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 | NCT02032823: 1/911 (0.1%) on Olaparib (serious AE) |
| Asthenia (weakness) | 613 | 1.6 1.5–1.8ROR 1.7 · χ² 157 / p 3e-36 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT03737643: 1/378 (0.3%) on Olaparib (serious AE) |
| Decreased appetite (loss of appetite) | 543 | 2.4 2.2–2.6ROR 2.4 · χ² 431 / p 5e-96 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | NCT02032823: 120/911 (13.2%) on Olaparib; 53/904 (5.9%) control |
| Disease progression | 517 | 4.4 4.1–4.8ROR 4.5 · χ² 1,374 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | not reported in cached trials |
| Myelodysplastic syndrome | 481 | 34.6 31.7–37.9ROR 35.4 · χ² 15,161 / p <1e-300 | 33.5 EB05 31.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.3 · 93% clinician | NCT03737643: 2/378 (0.5%) on Olaparib (serious AE) |
| Haemoglobin decreased | 441 | 4.3 4.0–4.8ROR 4.4 · χ² 1,129 / p 9e-248 | 4.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Metastases to pleura — n=28, PRR 27.8
- Haematotoxicity — n=175, PRR 19.4
- Metastases to lymph nodes — n=117, PRR 17.9
- Metastases to meninges — n=30, PRR 13.7
- Myelosuppression — n=432, PRR 13.0 (also seen in trial arm)
- Metastasis — n=91, PRR 12.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Olaparib?
In FDA FAERS, the most frequently co-reported reaction terms for Olaparib are nausea, fatigue, anaemia, vomiting, neuropathy peripheral, diarrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Olaparib have an FDA boxed warning?
No. The FDA label retrieved for Olaparib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Olaparib causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 741ff3e3-dc1a-45a6-84e5-2481b27131aa, effective 20250710; matched on
openfda.generic_name.exact:"OLAPARIB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,021 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
OLAPARIB, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.