NCT04644237 · STUDY IN CONTEXT
Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
Draft scope assessment: unclear. Attached because the study's own record names HER2 and describes metastatic 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
Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), was assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Confirmed objective response rate (ORR), defined as the percentage of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Duration of response (DoR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on blinded independent central review (BICR) and investigator assessment.
Overall survival (OS) is defined as the time from date of randomization until death from any cause.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- qol key
- qol-0011
- source section id
- NCT04644237-om-0011
- source outcome index
- 11
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
- measure definition
- The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. The QLQ-LC13 is a 13-item questionnaire designed to assess lung cancer-related symptoms and treatment side effects. The scales ranges from 1=not at all to 4=very much. The summation of scores range from 0 to 100, where higher scores represent increasing symptoms levels. scales.
- time frame
- At baseline and at end of treatment 40-day follow-up visit
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores for functioning scales and global health status indicate a better
- population note
- Full Analysis Set
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Time to Deterioration in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores
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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- qol key
- qol-0012
- source section id
- NCT04644237-om-0012
- source outcome index
- 12
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Time to Deterioration in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores
- measure definition
- The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
- time frame
- At baseline and at end of treatment 40-day follow-up visit
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores for functioning scales and global health status indicate a better
- population note
- Full Analysis Set
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- trial label
- Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
- applicability
- unclear
- applicability note
- Attached because the study's own record names HER2 and describes metastatic 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
- 2
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0000
- source section id
- NCT04644237-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Confirmed Objective Response Rate by Blinded Independent Central Review Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
- endpoint definition
- Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), was assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
- time origin
- 9 months after the last participant is randomized to data cut off, up to approximately 21 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0001
- source section id
- NCT04644237-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With Confirmed Objective Response Rate by Investigator Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung CancerTumors
- endpoint definition
- Confirmed objective response rate (ORR), defined as the percentage of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
- time origin
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0002
- source section id
- NCT04644237-om-0002
- source outcome index
- 2
- endpoint
- Duration of Response Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
- endpoint definition
- Duration of response (DoR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
- time origin
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set includes all subjects for whom study treatment was assigned by randomization. From the Full Analysis Set, 47 participants had a confirmed CR or PR in T-DXd 5.4 mg/kg arm, and 28 participants in T-DXd 6.4 mg/kg arm
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0003
- source section id
- NCT04644237-om-0003
- source outcome index
- 3
- endpoint
- Disease Control Rate Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
- endpoint definition
- Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
- time origin
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0004
- source section id
- NCT04644237-om-0004
- source outcome index
- 4
- endpoint
- Progression-free Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
- endpoint definition
- Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on blinded independent central review (BICR) and investigator assessment.
- time origin
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0005
- source section id
- NCT04644237-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors
- endpoint definition
- Overall survival (OS) is defined as the time from date of randomization until death from any cause.
- time origin
- 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Trastuzumab Deruxtecan 5.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 102
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Trastuzumab Deruxtecan 6.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Trastuzumab Deruxtecan 5.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 102
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Trastuzumab Deruxtecan 6.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Trastuzumab Deruxtecan 5.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Trastuzumab Deruxtecan 6.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Trastuzumab Deruxtecan 5.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 102
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Trastuzumab Deruxtecan 6.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Trastuzumab Deruxtecan 5.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 102
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Trastuzumab Deruxtecan 6.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Trastuzumab Deruxtecan 5.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 102
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Trastuzumab Deruxtecan 6.4 mg/kg
- regimen
- Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04644237-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- harm key
- EG000
- source section id
- NCT04644237-ae
- event group key
- EG000
- event group label
- Trastuzumab Deruxtecan 5.4 mg/kg
- serious affected
- 42
- serious at risk
- 101
- other affected
- 101
- other at risk
- 101
- frequency threshold
- 5
- collection period
- Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
- event definition
- A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- harm key
- EG001
- source section id
- NCT04644237-ae
- event group key
- EG001
- event group label
- Trastuzumab Deruxtecan 6.4 mg/kg
- serious affected
- 26
- serious at risk
- 50
- other affected
- 50
- other at risk
- 50
- frequency threshold
- 5
- collection period
- Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
- event definition
- A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- qol key
- qol-0011
- source section id
- NCT04644237-om-0011
- source outcome index
- 11
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
- measure definition
- The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. The QLQ-LC13 is a 13-item questionnaire designed to assess lung cancer-related symptoms and treatment side effects. The scales ranges from 1=not at all to 4=very much. The summation of scores range from 0 to 100, where higher scores represent increasing symptoms levels. scales.
- time frame
- At baseline and at end of treatment 40-day follow-up visit
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores for functioning scales and global health status indicate a better
- population note
- Full Analysis Set
- 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-non-small-cell-lung-cancer-bizengri-4710e9b9
- nct id
- NCT04644237
- qol key
- qol-0012
- source section id
- NCT04644237-om-0012
- source outcome index
- 12
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Time to Deterioration in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores
- measure definition
- The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
- time frame
- At baseline and at end of treatment 40-day follow-up visit
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher scores for functioning scales and global health status indicate a better
- population note
- Full Analysis Set
- 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
Triangle