TriangleNCT01248949 · OUTCOME
Number of Participants With Positive Anti-Drug Antibody (ADA)
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
- Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617
What was measured
The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.
Analysis population: All participants who received treatment with MEDI3617.
Groups in this outcome
MEDI3617 SINGLE AGENT TOTAL
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q2W TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + PACLITAXEL TOTAL
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
| Group | Source count |
|---|---|
| MEDI3617 SINGLE AGENT TOTAL | 42 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 16 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 38 |
| MEDI3617 + PACLITAXEL TOTAL | 13 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | 0 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 0 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 0 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + PACLITAXEL TOTAL | 0 | Not reported | Not reported | Not reported | Not reported |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | 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
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 7
- units
- Participants
- description
- The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.
- groups
- description
- Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG000
- title
- MEDI3617 SINGLE AGENT TOTAL
- description
- Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG001
- title
- MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
- description
- Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
- id
- OG002
- title
- MEDI3617 + BEVACIZUMAB Q2W TOTAL
- description
- Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
- id
- OG003
- title
- MEDI3617 + PACLITAXEL TOTAL
- description
- Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG004
- title
- MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
- param Type
- NUMBER
- population Description
- All participants who received treatment with MEDI3617.
- reporting Status
- POSTED
- time Frame
- Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617
- title
- Number of Participants With Positive Anti-Drug Antibody (ADA)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice