TriangleNCT00069121 · STUDY IN CONTEXT
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon 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 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
Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.
Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment.
A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- trial label
- A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon 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
- 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0000
- source section id
- NCT00069121-om-0000
- source outcome index
- 0
- endpoint
- Disease-Free Survival (DFS) [Number of Events]
- endpoint definition
- Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.
- time origin
- Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat 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-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0002
- source section id
- NCT00069121-om-0002
- source outcome index
- 2
- endpoint
- Disease-Free Survival (DFS) [Time to Event]
- endpoint definition
- Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- time origin
- Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
- 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-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0001
- source section id
- NCT00069121-om-0001
- source outcome index
- 1
- endpoint
- Relapse-Free Survival (RFS) [Number of Events]
- endpoint definition
- A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment.
- time origin
- Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
- 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-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0003
- source section id
- NCT00069121-om-0003
- source outcome index
- 3
- endpoint
- Relapse-Free Survival (RFS) [Time to Event]
- endpoint definition
- A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- time origin
- Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
- 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-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0004
- source section id
- NCT00069121-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival [Number of Events]
- endpoint definition
- Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
- time origin
- Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
- 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-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0005
- source section id
- NCT00069121-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival [Time to Event]
- endpoint definition
- Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- time origin
- Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
- 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-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 5-FU/LV
- regimen
- Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
- analyzed count
- 942
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0000
- arm key
- OG001
- arm label
- XELOX
- regimen
- Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
- analyzed count
- 944
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 5-FU/LV
- regimen
- Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
- analyzed count
- 942
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0001
- arm key
- OG001
- arm label
- XELOX
- regimen
- Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
- analyzed count
- 944
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 5-FU/LV
- regimen
- Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
- analyzed count
- 942
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0002
- arm key
- OG001
- arm label
- XELOX
- regimen
- Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
- analyzed count
- 944
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0003
- arm key
- OG000
- arm label
- 5-FU/LV
- regimen
- Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
- analyzed count
- 942
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0003
- arm key
- OG001
- arm label
- XELOX
- regimen
- Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
- analyzed count
- 944
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0004
- arm key
- OG000
- arm label
- 5-FU/LV
- regimen
- Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
- analyzed count
- 942
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0004
- arm key
- OG001
- arm label
- XELOX
- regimen
- Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
- analyzed count
- 944
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0005
- arm key
- OG000
- arm label
- 5-FU/LV
- regimen
- Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
- analyzed count
- 942
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- outcome key
- om-0005
- arm key
- OG001
- arm label
- XELOX
- regimen
- Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
- analyzed count
- 944
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00069121-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00069121
- harm key
- EG000
- source section id
- NCT00069121-ae
- event group key
- EG000
- event group label
- 5-FU/LV MAYO CLINIC
- serious affected
- 134
- serious at risk
- 657
- other affected
- 622
- other at risk
- 657
- frequency threshold
- 5
- collection period
- From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
- event definition
- AE reporting is based on the Safety Analysis Population; the patients who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin. Safety Population 5-FU/LV (n = 926); XELOX (n = 938)
- 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-colorectal-neoplasm
- nct id
- NCT00069121
- harm key
- EG001
- source section id
- NCT00069121-ae
- event group key
- EG001
- event group label
- 5-FU/LV ROSWELL PARK
- serious affected
- 88
- serious at risk
- 269
- other affected
- 262
- other at risk
- 269
- frequency threshold
- 5
- collection period
- From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
- event definition
- AE reporting is based on the Safety Analysis Population; the patients who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin. Safety Population 5-FU/LV (n = 926); XELOX (n = 938)
- 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-colorectal-neoplasm
- nct id
- NCT00069121
- harm key
- EG002
- source section id
- NCT00069121-ae
- event group key
- EG002
- event group label
- XELOX
- serious affected
- 208
- serious at risk
- 938
- other affected
- 926
- other at risk
- 938
- frequency threshold
- 5
- collection period
- From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
- event definition
- AE reporting is based on the Safety Analysis Population; the patients who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin. Safety Population 5-FU/LV (n = 926); XELOX (n = 938)
- 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
- setting source links
Preserved source evidence · Not medical advice