TriangleNCT02912559 · OUTCOME
Number of Patients Experiencing Adverse Events
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
- 5 years
What was measured
Assessed by Common Terminology Criteria for Adverse Events version 4.0. The number of patients experiencing a grade 3 or greater adverse event (AE) regardless of attribution will be reported.
Analysis population: Only patients that received treatment were included in AE analysis
Groups in this outcome
Arm I (Combination Chemotherapy, Atezolizumab)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
Arm II (Combination Chemotherapy)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
| Group | Source count |
|---|---|
| Arm I (Combination Chemotherapy, Atezolizumab) | 346 |
| Arm II (Combination Chemotherapy) | 334 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Combination Chemotherapy, Atezolizumab) | 291 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Combination Chemotherapy) | 240 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 291
- group Id
- OG001
- value
- 240
- denoms
- counts
- group Id
- OG000
- value
- 346
- group Id
- OG001
- value
- 334
- units
- Participants
- description
- Assessed by Common Terminology Criteria for Adverse Events version 4.0. The number of patients experiencing a grade 3 or greater adverse event (AE) regardless of attribution will be reported.
- groups
- description
- Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
- id
- OG000
- title
- Arm I (Combination Chemotherapy, Atezolizumab)
- description
- Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Biospecimen Collection: Undergo blood sample collection\> \> Computed Tomography: Undergo CT\> \> Fluorouracil: Given IV\> \> Leucovorin Calcium: Given IV\> \> Magnetic Resonance Imaging: Undergo MRI\> \> Oxaliplatin: Given IV\> \> Quality-of-Life Assessment: Ancillary studies
- id
- OG001
- title
- Arm II (Combination Chemotherapy)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Only patients that received treatment were included in AE analysis
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Number of Patients Experiencing Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7
Preserved source evidence · Not medical advice