TriangleNCT01013649 · OUTCOME
Number of Participants by Highest Grade Adverse Event Reported (Phase III)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
What was measured
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death.
Analysis population: Participants randomized at step 2.
Groups in this outcome
Arm III (Chemotherapy)
Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
Arm IV (Chemotherapy, Chemoradiotherapy)
Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
| Group | Source count |
|---|---|
| Arm III (Chemotherapy) | 174 |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 180 |
Reported measurements
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Chemotherapy) | 22 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 16 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Chemotherapy) | 50 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 56 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Chemotherapy) | 67 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 79 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Chemotherapy) | 21 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 23 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Chemotherapy) | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm IV (Chemotherapy, Chemoradiotherapy) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 16
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 56
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 79
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 23
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 174
- group Id
- OG001
- value
- 180
- units
- Participants
- description
- Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death.
- groups
- description
- Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
- id
- OG000
- title
- Arm III (Chemotherapy)
- description
- Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
- id
- OG001
- title
- Arm IV (Chemotherapy, Chemoradiotherapy)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants randomized at step 2.
- reporting Status
- POSTED
- time Frame
- From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
- title
- Number of Participants by Highest Grade Adverse Event Reported (Phase III)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice