TriangleNCT01327612 · OUTCOME
Number of Participants With 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
- 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
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.
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 | 2 | Not reported | Not reported | Not reported | Not reported |
| 20050171: Conatumumab 0.45 mg/kg | 1 | 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 | 1 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- 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
- An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.
- 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 Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice