TriangleNCT01183780 · OUTCOME
Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Cycles 1, 3, 5, and 30-Day FU
What was measured
Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)\*100.
Analysis population: All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.
Groups in this outcome
Ramucirumab + FOLFIRI
On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
Placebo + FOLFIRI
On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
| Group | Source count |
|---|---|
| Ramucirumab + FOLFIRI | 516 |
| Placebo + FOLFIRI | 512 |
Reported measurements
Immunogenicity Any Time During Study (n=516, 512)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + FOLFIRI | 5.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo + FOLFIRI | 5.5 | Not reported | Not reported | Not reported | Not reported |
Immunogenicity Post-Treatment (n=477, 473)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + FOLFIRI | 3.1 | Not reported | Not reported | Not reported | Not reported |
| Placebo + FOLFIRI | 3.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5.6
- group Id
- OG001
- value
- 5.5
- title
- Immunogenicity Any Time During Study (n=516, 512)
- categories
- measurements
- group Id
- OG000
- value
- 3.1
- group Id
- OG001
- value
- 3.8
- title
- Immunogenicity Post-Treatment (n=477, 473)
- denoms
- counts
- group Id
- OG000
- value
- 516
- group Id
- OG001
- value
- 512
- units
- Participants
- description
- Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)\*100.
- groups
- description
- On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
- id
- OG000
- title
- Ramucirumab + FOLFIRI
- description
- On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
- id
- OG001
- title
- Placebo + FOLFIRI
- param Type
- NUMBER
- population Description
- All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.
- reporting Status
- POSTED
- time Frame
- Cycles 1, 3, 5, and 30-Day FU
- title
- Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice