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Comparison · NCT02184195-495cbdb9

Olaparib 300 mg Twice Daily (bd) vs Placebo: Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Olaparib 300 mg Twice Daily (bd) vs Placebo: Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1. Trial comparisons, record NCT02184195-495cbdb9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02184195-495cbdb9

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3060.2110.42wilson
Risk in group 20.2240.130.359wilson
Risk difference, group 1 minus group 20.0811-0.0830.229newcombe hybrid score
Risk ratio, group 1 over group 21.360.7282.55log
Odds ratio, group 1 over group 21.520.6583.51log
Number needed to treat, for one more participant with the outcome on Olaparib 300 mg Twice Daily (bd) than on Placebo12.3from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Olaparib 300 mg Twice Daily (bd)Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.2272OG000
Group 2PlaceboRandomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.1149OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1
Description
To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.
Time frame
Up to 4 years
Population
All randomised patients with measurable disease at baseline.

Source ClinicalTrials.gov

Trial

Title
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
NCT number
NCT02184195
Phases
PHASE3
Conditions
Germline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the Pancreas
Interventions
Olaparib, Olaparib, Placebo, Placebo
Lead sponsor
AstraZeneca
Results first posted
2020-01-27

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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