TriangleNCT01380145 · OUTCOME
Induction or Augmentation of MAGE-A3-Specific Humoral Immunity
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, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT
What was measured
Humoral immunity was determined by enzyme-linked immunosorbent assay (ELISA) to measure the presence of circulating antibodies to MAGE-A3. Titers against an antigen were considered significant if they were \>100. Induction of responses was considered significant if there was a change from undetectable (\<100) to detectable (\>100) or if there was an at least 4-fold increase in titers over time.
Analysis population: The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
Groups in this outcome
Immunogenicity Analysis Set
Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
| Group | Source count |
|---|---|
| Immunogenicity Analysis Set | 13 |
Reported measurements
Seroconversion after 1 immunization
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Immunogenicity Analysis Set | 3 | Not reported | Not reported | Not reported | Not reported |
Seroconversion after 2 immunizations
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Immunogenicity Analysis Set | 8 | Not reported | Not reported | Not reported | Not reported |
Seroconversion after 3-4 immunizations
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Immunogenicity Analysis Set | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Seroconversion after 1 immunization
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- Seroconversion after 2 immunizations
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Seroconversion after 3-4 immunizations
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- description
- Humoral immunity was determined by enzyme-linked immunosorbent assay (ELISA) to measure the presence of circulating antibodies to MAGE-A3. Titers against an antigen were considered significant if they were \>100. Induction of responses was considered significant if there was a change from undetectable (\<100) to detectable (\>100) or if there was an at least 4-fold increase in titers over time.
- groups
- description
- Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
- id
- OG000
- title
- Immunogenicity Analysis Set
- param Type
- NUMBER
- population Description
- The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
- reporting Status
- POSTED
- time Frame
- Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT
- title
- Induction or Augmentation of MAGE-A3-Specific Humoral Immunity
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice