TriangleNCT00917384 · OUTCOME
Number of Participants Who Developed Antibodies Against IMC-1121B
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
- Baseline, 12 Weeks
What was measured
The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
Analysis population: Subset of the Safety Population: All randomized participants who received at least 1 dose of study drug and who had immunogenicity analysis performed.
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) | 207 |
| Placebo | 106 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMC-1121B (Ramucirumab) | 6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 207
- group Id
- OG001
- value
- 106
- units
- Participants
- description
- The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
- 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
- Subset of the Safety Population: All randomized participants who received at least 1 dose of study drug and who had immunogenicity analysis performed.
- reporting Status
- POSTED
- time Frame
- Baseline, 12 Weeks
- title
- Number of Participants Who Developed Antibodies Against IMC-1121B
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice