TriangleNCT00917384 · 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
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Randomization up to 18 months
What was measured
Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.
Analysis population: Safety Population: All randomized participants who received at least 1 dose of study drug.
Groups in this outcome
IMC-1121B (Ramucirumab)
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Placebo
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
| Group | Source count |
|---|---|
| IMC-1121B (Ramucirumab) | 236 |
| Placebo | 115 |
Reported measurements
Participants with SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMC-1121B (Ramucirumab) | 112 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 51 | Not reported | Not reported | Not reported | Not reported |
Participants with ≥ 1 treatment emergent NSAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMC-1121B (Ramucirumab) | 213 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 91 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 51
- title
- Participants with SAE
- categories
- measurements
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 91
- title
- Participants with ≥ 1 treatment emergent NSAE
- denoms
- counts
- group Id
- OG000
- value
- 236
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.
- groups
- description
- Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- id
- OG000
- title
- IMC-1121B (Ramucirumab)
- description
- Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Safety Population: All randomized participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Randomization up to 18 months
- title
- Number of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice