TriangleNCT00364013 · OUTCOME
Number of Participants With Adverse Events (AEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.
What was measured
A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?"
Analysis population: Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX', but received 'FOLFOX Alone' so is counted in that group.
Groups in this outcome
FOLFOX + Panitumumab
Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
FOLFOX Alone
Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
| Group | Source count |
|---|---|
| FOLFOX + Panitumumab | 585 |
| FOLFOX Alone | 584 |
Reported measurements
Any adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FOLFOX + Panitumumab | 583 | Not reported | Not reported | Not reported | Not reported |
| FOLFOX Alone | 579 | Not reported | Not reported | Not reported | Not reported |
Serious adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FOLFOX + Panitumumab | 262 | Not reported | Not reported | Not reported | Not reported |
| FOLFOX Alone | 198 | Not reported | Not reported | Not reported | Not reported |
Leading to discontinuation of any study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FOLFOX + Panitumumab | 136 | Not reported | Not reported | Not reported | Not reported |
| FOLFOX Alone | 84 | Not reported | Not reported | Not reported | Not reported |
Treatment-related adverse event (TRAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FOLFOX + Panitumumab | 581 | Not reported | Not reported | Not reported | Not reported |
| FOLFOX Alone | 565 | Not reported | Not reported | Not reported | Not reported |
Serious treatment-related adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FOLFOX + Panitumumab | 162 | Not reported | Not reported | Not reported | Not reported |
| FOLFOX Alone | 89 | Not reported | Not reported | Not reported | Not reported |
TRAE leading to discontinuation of any study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FOLFOX + Panitumumab | 117 | Not reported | Not reported | Not reported | Not reported |
| FOLFOX Alone | 63 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 583
- group Id
- OG001
- value
- 579
- title
- Any adverse event
- categories
- measurements
- group Id
- OG000
- value
- 262
- group Id
- OG001
- value
- 198
- title
- Serious adverse event
- categories
- measurements
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 84
- title
- Leading to discontinuation of any study drug
- categories
- measurements
- group Id
- OG000
- value
- 581
- group Id
- OG001
- value
- 565
- title
- Treatment-related adverse event (TRAE)
- categories
- measurements
- group Id
- OG000
- value
- 162
- group Id
- OG001
- value
- 89
- title
- Serious treatment-related adverse event
- categories
- measurements
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 63
- title
- TRAE leading to discontinuation of any study drug
- denoms
- counts
- group Id
- OG000
- value
- 585
- group Id
- OG001
- value
- 584
- units
- Participants
- description
- A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?"
- groups
- description
- Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- FOLFOX + Panitumumab
- description
- Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
- id
- OG001
- title
- FOLFOX Alone
- param Type
- NUMBER
- population Description
- Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX', but received 'FOLFOX Alone' so is counted in that group.
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.
- title
- Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice