TriangleNCT00275262 · OUTCOME
Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mcg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Month 6 prevaccination (baseline) and Month 7 postvaccination
What was measured
Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.
Analysis population: Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
Groups in this outcome
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
Placebo
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
| Group | Source count |
|---|---|
| Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month | 8 |
| Placebo | 5 |
Reported measurements
Mean IgM at baseline (mcg/mL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month | 4.0 | 3.8 | 0.99 | 7.38 | Not reported |
| Placebo | 3.0 | 2.8 | -0.16 | 1.84 | Not reported |
Mean IgM change from baseline (mcg/mL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month | 2.91 | 2.07 | Not reported | Not reported | Not reported |
| Placebo | 0.57 | 0.83 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.99
- spread
- 3.8
- upper Limit
- 7.38
- value
- 4.0
- group Id
- OG001
- lower Limit
- -0.16
- spread
- 2.8
- upper Limit
- 1.84
- value
- 3.0
- title
- Mean IgM at baseline (mcg/mL)
- categories
- measurements
- group Id
- OG000
- spread
- 2.07
- value
- 2.91
- group Id
- OG001
- spread
- 0.83
- value
- 0.57
- title
- Mean IgM change from baseline (mcg/mL)
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
- id
- OG000
- title
- Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
- description
- Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
- reporting Status
- POSTED
- time Frame
- Month 6 prevaccination (baseline) and Month 7 postvaccination
- title
- Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
- type
- PRIMARY
- unit Of Measure
- mcg/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice