TriangleNCT01327612 · OUTCOME
Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
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 first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
What was measured
Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Analysis population: Participants who received at least one dose of conatumumab or ganitumab.
Groups in this outcome
20050118: Ganitumab 20 mg/kg
Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
20050171: Conatumumab 0.45 mg/kg
Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
20060295: Conatumumab 3 mg/kg
Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
20060340: Conatumumab 5 mg/kg
Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
| Group | Source count |
|---|---|
| 20050118: Ganitumab 20 mg/kg | 2 |
| 20050171: Conatumumab 0.45 mg/kg | 1 |
| 20060295: Conatumumab 3 mg/kg | 1 |
| 20060340: Conatumumab 5 mg/kg | 1 |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | 2 |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | 3 |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20050171: Conatumumab 0.45 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060295: Conatumumab 3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 20060340: Conatumumab 5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | 2 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | 2 | Not reported | Not reported | Not reported | Not reported |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- units
- Participants
- description
- Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
- groups
- description
- Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
- id
- OG000
- title
- 20050118: Ganitumab 20 mg/kg
- description
- Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
- id
- OG001
- title
- 20050171: Conatumumab 0.45 mg/kg
- description
- Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
- id
- OG002
- title
- 20060295: Conatumumab 3 mg/kg
- description
- Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
- id
- OG003
- title
- 20060340: Conatumumab 5 mg/kg
- description
- Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
- id
- OG004
- title
- 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
- description
- Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
- id
- OG005
- title
- 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
- description
- Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
- id
- OG006
- title
- 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received at least one dose of conatumumab or ganitumab.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
- title
- Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice