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NCT02184195 · OUTCOME

Number of Participants With Adverse Events (AEs)

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy · Source last updated 2023-09-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 4 years

What was measured

To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events

Analysis population: Safety Analysis Set consisted of all patients who received at least one dose of study treatment.

Groups in this outcome

Olaparib 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.

Placebo

Randomised 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Olaparib 300 mg Twice Daily (bd)90
Placebo61

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)89Not reportedNot reportedNot reportedNot reported
Placebo56Not reportedNot reportedNot reportedNot reported
Any AE of CTCAE Grade 3 or higher
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)44Not reportedNot reportedNot reportedNot reported
Placebo15Not reportedNot reportedNot reportedNot reported
Any AE with outcome = death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)1Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Any SAE (including events with outcome = death)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)28Not reportedNot reportedNot reportedNot reported
Placebo10Not reportedNot reportedNot reportedNot reported
AnyAE leading to withdrawal of olaparib/placebo
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)8Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported
Any AE leading to dose interruption
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)38Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
Any AE leading to dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)16Not reportedNot reportedNot reportedNot reported
Placebo3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        56
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        15
    title
    Any AE of CTCAE Grade 3 or higher
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Any AE with outcome = death
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        10
    title
    Any SAE (including events with outcome = death)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        1
    title
    AnyAE leading to withdrawal of olaparib/placebo
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        4
    title
    Any AE leading to dose interruption
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        3
    title
    Any AE leading to dose reduction
denoms
  1. counts
    1. group Id
      OG000
      value
      90
    2. group Id
      OG001
      value
      61
    units
    Participants
description
To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events
groups
  1. description
    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.
    id
    OG000
    title
    Olaparib 300 mg Twice Daily (bd)
  2. description
    Randomised 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.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Safety Analysis Set consisted of all patients who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to 4 years
title
Number of Participants With Adverse Events (AEs)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice