TriangleNCT01140347 · OUTCOME
Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]
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
- Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles)
What was measured
Participants were considered positive for anti-ramucirumab antibodies \[anti-drug antibodies (ADA)\] if the post-treatment sample had an increase of at least 4-fold in titer from the pretreatment values. If the pretreatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence of ADA.
Analysis population: Participants who received at least 1 dose of study drug and had post-treatment ADA analysis.
Groups in this outcome
Ramucirumab (IMC-1121B) + BSC
Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
Placebo + BSC
Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
| Group | Source count |
|---|---|
| Ramucirumab (IMC-1121B) + BSC | 241 |
| Placebo + BSC | 231 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab (IMC-1121B) + BSC | 10 | Not reported | Not reported | Not reported | Not reported |
| Placebo + BSC | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 241
- group Id
- OG001
- value
- 231
- units
- Participants
- description
- Participants were considered positive for anti-ramucirumab antibodies \[anti-drug antibodies (ADA)\] if the post-treatment sample had an increase of at least 4-fold in titer from the pretreatment values. If the pretreatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence of ADA.
- groups
- description
- Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- id
- OG000
- title
- Ramucirumab (IMC-1121B) + BSC
- description
- Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- id
- OG001
- title
- Placebo + BSC
- param Type
- NUMBER
- population Description
- Participants who received at least 1 dose of study drug and had post-treatment ADA analysis.
- reporting Status
- POSTED
- time Frame
- Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles)
- title
- Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice