TriangleNCT02564198 · OUTCOME
Number of Participants With Anti-Ramucirumab Antibodies
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
- Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months)
What was measured
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.
Analysis population: All randomized participants who received at least one dose of study drug.
Groups in this outcome
8 mg/kg Ramucirumab (Part A)
Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.
12 mg/kg Ramucirumab (Part A)
Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
12 mg/kg Ramucirumab (Part B)
Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
| Group | Source count |
|---|---|
| 8 mg/kg Ramucirumab (Part A) | 8 |
| 12 mg/kg Ramucirumab (Part A) | 15 |
| 12 mg/kg Ramucirumab (Part B) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 8 mg/kg Ramucirumab (Part A) | 0 | Not reported | Not reported | Not reported | Not reported |
| 12 mg/kg Ramucirumab (Part A) | 0 | Not reported | Not reported | Not reported | Not reported |
| 12 mg/kg Ramucirumab (Part B) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.
- groups
- description
- Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.
- id
- OG000
- title
- 8 mg/kg Ramucirumab (Part A)
- description
- Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
- id
- OG001
- title
- 12 mg/kg Ramucirumab (Part A)
- description
- Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
- id
- OG002
- title
- 12 mg/kg Ramucirumab (Part B)
- param Type
- NUMBER
- population Description
- All randomized participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months)
- title
- Number of Participants With Anti-Ramucirumab Antibodies
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice