TriangleNCT03353753 · STUDY IN CONTEXT
Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
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 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
PFS was defined as the time interval between the date of randomization and the earliest documented evidence of the first disease progression based on the independent radiologic review or death due to any cause on initially assigned study treatment, whichever comes earlier, assessed at 26, 39, and 52 weeks.
The percentage of patients with a confirmed complete response or PR (CR: Disappearance of all target lesions and non-target lesions (if present at baseline); all lymph nodes must be non-pathological in size) or partial response (PR: \>=30% decrease in the Sum of Diameters of target lesions and non-target lesions non-PD or NE or none at baseline; or target lesions CR and non-target lesions non-CR/Non-PD or NE) based on the independent radiologic review and during the initially assigned study treatment. To be assigned a status of a CR or PR, changes in tumor measurements must be confirmed by repeat CT or MRI assessments that must be performed at least 4 weeks after the criteria for response are first met.
TTP is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review.
Overall Survival (OS) was defined as the interval between the date of randomization until the date of death or the date of last follow-up.
Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item - Role Functioning. For the ripretinib arm the minimum and maximum for the outcome were -67 to 67; the placebo arm had a range of -83 to 67. The higher value represents a higher quality of life in disease-related symptoms.
Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Physical Functioning. For the ripretinib arm, the minimum and maximum for the outcome were -33 to 53; the placebo arm had a range of -47 to 20. The higher value represents a higher quality of life in disease-related symptoms.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- qol key
- qol-0004
- source section id
- NCT03353753-om-0004
- source outcome index
- 4
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
- measure definition
- Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item - Role Functioning. For the ripretinib arm the minimum and maximum for the outcome were -67 to 67; the placebo arm had a range of -83 to 67. The higher value represents a higher quality of life in disease-related symptoms.
- time frame
- From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT Population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Quality of Life & Disease-Related Symptoms - Physical Functioning
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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- qol key
- qol-0005
- source section id
- NCT03353753-om-0005
- source outcome index
- 5
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Quality of Life & Disease-Related Symptoms - Physical Functioning
- measure definition
- Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Physical Functioning. For the ripretinib arm, the minimum and maximum for the outcome were -33 to 53; the placebo arm had a range of -47 to 20. The higher value represents a higher quality of life in disease-related symptoms.
- time frame
- From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT Population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- qol key
- qol-0006
- source section id
- NCT03353753-om-0006
- source outcome index
- 6
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
- measure definition
- Change from baseline in EuroQol Visual Analogue Scale. For the ripretinib arm the minimum and maximum for the outcome were -43 to 91; the placebo arm had a range of -68 to 23. The higher value represents a higher quality of life in disease-related symptoms.
- time frame
- From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- trial label
- Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
- 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
- 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
- 2
- qol Count
- 3
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0000
- source section id
- NCT03353753-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- PFS was defined as the time interval between the date of randomization and the earliest documented evidence of the first disease progression based on the independent radiologic review or death due to any cause on initially assigned study treatment, whichever comes earlier, assessed at 26, 39, and 52 weeks.
- time origin
- From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0001
- source section id
- NCT03353753-om-0001
- source outcome index
- 1
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- The percentage of patients with a confirmed complete response or PR (CR: Disappearance of all target lesions and non-target lesions (if present at baseline); all lymph nodes must be non-pathological in size) or partial response (PR: \>=30% decrease in the Sum of Diameters of target lesions and non-target lesions non-PD or NE or none at baseline; or target lesions CR and non-target lesions non-CR/Non-PD or NE) based on the independent radiologic review and during the initially assigned study treatment. To be assigned a status of a CR or PR, changes in tumor measurements must be confirmed by repeat CT or MRI assessments that must be performed at least 4 weeks after the criteria for response are first met.
- time origin
- From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0002
- source section id
- NCT03353753-om-0002
- source outcome index
- 2
- endpoint
- Time to Tumor Progression (TTP) Based on Independent Radiologic Review
- endpoint definition
- TTP is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review.
- time origin
- From date of randomization to the earliest date of disease progression [through database cutoff 31-May-2019 (up to approximately 15 months)].
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0003
- source section id
- NCT03353753-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall Survival (OS) was defined as the interval between the date of randomization until the date of death or the date of last follow-up.
- time origin
- From the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0004
- source section id
- NCT03353753-om-0004
- source outcome index
- 4
- endpoint
- Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
- endpoint definition
- Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item - Role Functioning. For the ripretinib arm the minimum and maximum for the outcome were -67 to 67; the placebo arm had a range of -83 to 67. The higher value represents a higher quality of life in disease-related symptoms.
- time origin
- From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0005
- source section id
- NCT03353753-om-0005
- source outcome index
- 5
- endpoint
- Quality of Life & Disease-Related Symptoms - Physical Functioning
- endpoint definition
- Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Physical Functioning. For the ripretinib arm, the minimum and maximum for the outcome were -33 to 53; the placebo arm had a range of -47 to 20. The higher value represents a higher quality of life in disease-related symptoms.
- time origin
- From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Ripretinib
- regimen
- Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 85
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Ripretinib
- regimen
- Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 85
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Ripretinib
- regimen
- Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 85
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Ripretinib
- regimen
- Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 85
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Ripretinib
- regimen
- Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 85
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Ripretinib
- regimen
- Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 85
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03353753-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- harm key
- EG000
- source section id
- NCT03353753-ae
- event group key
- EG000
- event group label
- Ripretinib
- serious affected
- 26
- serious at risk
- 85
- other affected
- 84
- other at risk
- 85
- frequency threshold
- 5
- collection period
- After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
- event definition
- Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- harm key
- EG001
- source section id
- NCT03353753-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 19
- serious at risk
- 43
- other affected
- 42
- other at risk
- 43
- frequency threshold
- 5
- collection period
- After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
- event definition
- Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- qol key
- qol-0004
- source section id
- NCT03353753-om-0004
- source outcome index
- 4
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
- measure definition
- Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item - Role Functioning. For the ripretinib arm the minimum and maximum for the outcome were -67 to 67; the placebo arm had a range of -83 to 67. The higher value represents a higher quality of life in disease-related symptoms.
- time frame
- From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- qol key
- qol-0005
- source section id
- NCT03353753-om-0005
- source outcome index
- 5
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Quality of Life & Disease-Related Symptoms - Physical Functioning
- measure definition
- Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Physical Functioning. For the ripretinib arm, the minimum and maximum for the outcome were -33 to 53; the placebo arm had a range of -47 to 20. The higher value represents a higher quality of life in disease-related symptoms.
- time frame
- From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT Population
- 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-gastrointestinal-stromal-tumors
- nct id
- NCT03353753
- qol key
- qol-0006
- source section id
- NCT03353753-om-0006
- source outcome index
- 6
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
- measure definition
- Change from baseline in EuroQol Visual Analogue Scale. For the ripretinib arm the minimum and maximum for the outcome were -43 to 91; the placebo arm had a range of -68 to 23. The higher value represents a higher quality of life in disease-related symptoms.
- time frame
- From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- ITT Population
- 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