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← Vegzelma: recurrent peritoneal cancer

NCT02855944 · STUDY IN CONTEXT

ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Efficacy Population - All randomized patients in the treatment part of study with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation. As noted in the Baseline Characteristics Module, 1 patient in the Chemotherapy Arm did not have a BRCA mutation (Non-BRCA) and is therefore excluded from the overall number of patients analyzed.

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primary · POSTED

The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Intent-to-treat (ITT) Population - All randomized patients in the treatment part of study.

→

secondary · POSTED

A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Efficacy population with measurable disease at baseline. Efficacy population defined as all randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation.

→

secondary · POSTED

A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Intent-to-treat (ITT) population with measurable disease at baseline. ITT population defined as all randomized patients.

→

secondary · POSTED

A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Efficacy population with measurable disease at baseline and a confirmed response. Efficacy population defined as all randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation. As noted in the Baseline Characteristics Module, 1 patient in the Chemotherapy Arm did not have a BRCA mutation (Non-BRCA) and is therefore excluded from the overall number of patients analyzed.

→

secondary · POSTED

A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Intent-to-treat (ITT) population with measurable disease at baseline and a confirmed response. ITT population defined as all randomized patients.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT02855944
qol key
qol-0008
source section id
NCT02855944-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)
measure definition
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed.
time frame
Baseline to the end of Cycle 6, or up to approximately 6 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicating improved
population note
Efficacy population - All randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation, and with a baseline value and at least one post-baseline value for the EORTC QLQ-C30 Global Health Status score during the first 6 cycles.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT02855944
qol key
qol-0009
source section id
NCT02855944-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population)
measure definition
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed.
time frame
Baseline to the end of Cycle 6, or up to approximately 6 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicating improved
population note
Intent-to-treat (ITT) population - All randomized patients with a baseline value and at least one post-baseline value for the EORTC QLQ-C30 Global Health Status score during the first 6 cycles.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT02855944
trial label
ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0000
    source section id
    NCT02855944-om-0000
    source outcome index
    0
    endpoint
    Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)
    endpoint definition
    The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    time origin
    Assessments every 8 weeks from Cycle 1 Day 1 (C1D1) until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy Population - All randomized patients in the treatment part of study with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation. As noted in the Baseline Characteristics Module, 1 patient in the Chemotherapy Arm did not have a BRCA mutation (Non-BRCA) and is therefore excluded from the overall number of patients analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0001
    source section id
    NCT02855944-om-0001
    source outcome index
    1
    endpoint
    Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population)
    endpoint definition
    The primary efficacy endpoint is invPFS for the Treatment Part of the study. The time to invPFS is calculated in months as the time from randomization to disease progression +1 day, as determined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    time origin
    Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) Population - All randomized patients in the treatment part of study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0002
    source section id
    NCT02855944-om-0002
    source outcome index
    2
    endpoint
    Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (Efficacy Population)
    endpoint definition
    A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
    time origin
    Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy population with measurable disease at baseline. Efficacy population defined as all randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0003
    source section id
    NCT02855944-om-0003
    source outcome index
    3
    endpoint
    Investigator Assessed Overall Response Rate (ORR) by RECIST v1.1 (ITT Population)
    endpoint definition
    A secondary endpoint is the ORR for the Treatment Part of the study. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by RECIST v1.1. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
    time origin
    Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) population with measurable disease at baseline. ITT population defined as all randomized patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0004
    source section id
    NCT02855944-om-0004
    source outcome index
    4
    endpoint
    Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (Efficacy Population)
    endpoint definition
    A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    time origin
    Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy population with measurable disease at baseline and a confirmed response. Efficacy population defined as all randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation. As noted in the Baseline Characteristics Module, 1 patient in the Chemotherapy Arm did not have a BRCA mutation (Non-BRCA) and is therefore excluded from the overall number of patients analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0005
    source section id
    NCT02855944-om-0005
    source outcome index
    5
    endpoint
    Investigator Assessed Duration of Response (DOR) by RECIST v1.1 (ITT Population)
    endpoint definition
    A secondary endpoint is the DOR for the Treatment Part of the study. The DOR as assessed by investigator is analyzed in the subgroup of patients who had a confirmed response by RECIST v1.1. DOR for any confirmed RECIST CR or PR will be measured from the date of the first response until the first date that progressive disease (PD) is documented. DOR is calculated in months as the time from the first date of the scan showing a response to the first scan with disease progression +1 day. Any patients with an ongoing response are censored at the date of the last post-baseline scan. Only tumor scans up to and within 6 weeks of start of any subsequent anti-cancer treatment are included. Progressive disease (PD) is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    time origin
    Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) population with measurable disease at baseline and a confirmed response. ITT population defined as all randomized patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Rucaparib
    regimen
    Patients randomized to the rucaparib arm.
    analyzed count
    220
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Patients randomized to the chemotherapy arm.
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Rucaparib
    regimen
    Patients randomized to the rucaparib arm.
    analyzed count
    233
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Patients randomized to the chemotherapy arm.
    analyzed count
    116
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Rucaparib
    regimen
    Patients randomized to the rucaparib arm.
    analyzed count
    211
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Patients randomized to the chemotherapy arm.
    analyzed count
    96
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Rucaparib
    regimen
    Patients randomized to the rucaparib arm.
    analyzed count
    224
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Patients randomized to the chemotherapy arm.
    analyzed count
    106
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Rucaparib
    regimen
    Patients randomized to the rucaparib arm.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Patients randomized to the chemotherapy arm.
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Rucaparib
    regimen
    Patients randomized to the rucaparib arm.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Chemotherapy
    regimen
    Patients randomized to the chemotherapy arm.
    analyzed count
    32
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02855944-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    harm key
    EG000
    source section id
    NCT02855944-ae
    event group key
    EG000
    event group label
    Rucaparib (Treatment Part)
    serious affected
    66
    serious at risk
    232
    other affected
    229
    other at risk
    232
    frequency threshold
    5
    collection period
    Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 3.5 years.
    event definition
    Adverse events are reported for the Safety Population, defined as patients who received at least one dose of protocol-specified treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    harm key
    EG001
    source section id
    NCT02855944-ae
    event group key
    EG001
    event group label
    Chemotherapy (Treatment Part)
    serious affected
    14
    serious at risk
    113
    other affected
    109
    other at risk
    113
    frequency threshold
    5
    collection period
    Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 3.5 years.
    event definition
    Adverse events are reported for the Safety Population, defined as patients who received at least one dose of protocol-specified treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    harm key
    EG002
    source section id
    NCT02855944-ae
    event group key
    EG002
    event group label
    Rucaparib (Crossover Part)
    serious affected
    24
    serious at risk
    80
    other affected
    76
    other at risk
    80
    frequency threshold
    5
    collection period
    Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 3.5 years.
    event definition
    Adverse events are reported for the Safety Population, defined as patients who received at least one dose of protocol-specified treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    qol key
    qol-0008
    source section id
    NCT02855944-om-0008
    source outcome index
    8
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (Efficacy Population)
    measure definition
    EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed.
    time frame
    Baseline to the end of Cycle 6, or up to approximately 6 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score indicating improved
    population note
    Efficacy population - All randomized patients with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation, and with a baseline value and at least one post-baseline value for the EORTC QLQ-C30 Global Health Status score during the first 6 cycles.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT02855944
    qol key
    qol-0009
    source section id
    NCT02855944-om-0009
    source outcome index
    9
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Least Squares Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for the First 6 Cycles (ITT Population)
    measure definition
    EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer patients. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. Mean changes from baseline global score over the first 6 cycles in the Treatment Part of the study were analyzed.
    time frame
    Baseline to the end of Cycle 6, or up to approximately 6 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score indicating improved
    population note
    Intent-to-treat (ITT) population - All randomized patients with a baseline value and at least one post-baseline value for the EORTC QLQ-C30 Global Health Status score during the first 6 cycles.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice