TriangleNCT02101788 · STUDY IN CONTEXT
Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.
Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy. Excludes AEs observed among control patients treated with trametinib after crossover.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the AE endpoint definition.
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Patients with disease progression on the Control arm were allowed to cross over to the trametinib arm. Per the protocol, the intent-to-treat OS analysis was not adjusted for crossover.
The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
Reported safety
Quality of life and patient-reported measures
FACT · Patients Reported Acute Quality of Life
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- qol key
- qol-0004
- source section id
- NCT02101788-om-0004
- source outcome index
- 4
- instrument
- FACT
- instrument basis
- matched 'fact-o' in the study's own wording
- scale title
- Patients Reported Acute Quality of Life
- measure definition
- Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
- time frame
- 1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Patients who provided baseline and ≥ 1 follow-up assessment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Patient Reported Acute Peripheral Neuropathy Symptoms
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- qol key
- qol-0005
- source section id
- NCT02101788-om-0005
- source outcome index
- 5
- instrument
- FACT
- instrument basis
- matched 'fact' in the study's own wording
- scale title
- Patient Reported Acute Peripheral Neuropathy Symptoms
- measure definition
- Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
- time frame
- Up to 52 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Patients that provided baseline and ≥ 1 follow-up assessment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- trial label
- Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0000
- source section id
- NCT02101788-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.
- time origin
- Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0001
- source section id
- NCT02101788-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Adverse Events (AEs)
- endpoint definition
- Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy. Excludes AEs observed among control patients treated with trametinib after crossover.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the AE endpoint definition.
- time origin
- During treatment period and up to 100 days after stopping the study treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treated with randomized therapy
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0002
- source section id
- NCT02101788-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Patients with disease progression on the Control arm were allowed to cross over to the trametinib arm. Per the protocol, the intent-to-treat OS analysis was not adjusted for crossover.
- time origin
- Time from study entry to time of death or date of last contact, an average of 29 months for arm A and 37 months for arm B
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0003
- source section id
- NCT02101788-om-0003
- source outcome index
- 3
- endpoint
- Objective Tumor Response Rate (Complete Response and Partial Response)
- endpoint definition
- The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.
- time origin
- Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0004
- source section id
- NCT02101788-om-0004
- source outcome index
- 4
- endpoint
- Patients Reported Acute Quality of Life
- endpoint definition
- Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
- time origin
- 1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who provided baseline and ≥ 1 follow-up assessment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0005
- source section id
- NCT02101788-om-0005
- source outcome index
- 5
- endpoint
- Patient Reported Acute Peripheral Neuropathy Symptoms
- endpoint definition
- Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
- time origin
- Up to 52 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients that provided baseline and ≥ 1 follow-up assessment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A - Control Arm
- regimen
- Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
- analyzed count
- 130
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B - Experimental Arm
- regimen
- Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
- analyzed count
- 130
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A - Control Arm
- regimen
- Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
- analyzed count
- 127
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B - Experimental Arm
- regimen
- Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
- analyzed count
- 127
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A - Control Arm
- regimen
- Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
- analyzed count
- 130
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B - Experimental Arm
- regimen
- Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
- analyzed count
- 130
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A - Control Arm
- regimen
- Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
- analyzed count
- 130
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B - Experimental Arm
- regimen
- Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
- analyzed count
- 130
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)
- regimen
- Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B. Letrozole: Given PO Paclitaxel: Given IV Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies Tamoxifen: Given PO Tamoxifen Citrate: Given PO Topotecan: Given IV Topotecan Hydrochloride: Given IV
- analyzed count
- 98
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm B (Trametinib)
- regimen
- Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment: Ancillary studies Trametinib: Given PO Trametinib Dimethyl Sulfoxide: Given PO
- analyzed count
- 100
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm A (Letrozole, Tamoxifen, Paclitaxel, PLD, Topotecan)
- regimen
- Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B. Letrozole: Given PO Paclitaxel: Given IV Pegylated Liposomal Doxorubicin Hydrochloride: Given IV Quality-of-Life Assessment: Ancillary studies Tamoxifen: Given PO Tamoxifen Citrate: Given PO Topotecan: Given IV Topotecan Hydrochloride: Given IV
- analyzed count
- 98
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm B (Trametinib)
- regimen
- Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment: Ancillary studies Trametinib: Given PO Trametinib Dimethyl Sulfoxide: Given PO
- analyzed count
- 100
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02101788-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- harm key
- EG000
- source section id
- NCT02101788-ae
- event group key
- EG000
- event group label
- Arm A - Control Arm
- serious affected
- 43
- serious at risk
- 127
- other affected
- 124
- other at risk
- 127
- frequency threshold
- 0
- collection period
- Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- harm key
- EG001
- source section id
- NCT02101788-ae
- event group key
- EG001
- event group label
- Arm B - Experimental Arm
- serious affected
- 45
- serious at risk
- 127
- other affected
- 127
- other at risk
- 127
- frequency threshold
- 0
- collection period
- Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- harm key
- EG002
- source section id
- NCT02101788-ae
- event group key
- EG002
- event group label
- Crossover From Control to Experimental Arm
- serious affected
- 25
- serious at risk
- 88
- other affected
- 88
- other at risk
- 88
- frequency threshold
- 0
- collection period
- Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
- event definition
- Source null
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- qol key
- qol-0004
- source section id
- NCT02101788-om-0004
- source outcome index
- 4
- instrument
- FACT
- instrument basis
- matched 'fact-o' in the study's own wording
- scale title
- Patients Reported Acute Quality of Life
- measure definition
- Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
- time frame
- 1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Patients who provided baseline and ≥ 1 follow-up assessment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-primary-peritoneal-carcinoma
- nct id
- NCT02101788
- qol key
- qol-0005
- source section id
- NCT02101788-om-0005
- source outcome index
- 5
- instrument
- FACT
- instrument basis
- matched 'fact' in the study's own wording
- scale title
- Patient Reported Acute Peripheral Neuropathy Symptoms
- measure definition
- Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
- time frame
- Up to 52 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Patients that provided baseline and ≥ 1 follow-up assessment
- 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