TriangleNCT00958841 · OUTCOME
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
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, month 6
What was measured
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
Analysis population: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
Groups in this outcome
All PNETS (Gastrinoma)
One of the 10 types of PNETs analyzed
| Group | Source count |
|---|---|
| All PNETS (Gastrinoma) | 20 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All PNETS (Gastrinoma) | 8 | Not reported | Not reported | Not reported | Not reported |
Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All PNETS (Gastrinoma) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- Month 6
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
- groups
- description
- One of the 10 types of PNETs analyzed
- id
- OG000
- title
- All PNETS (Gastrinoma)
- param Type
- NUMBER
- population Description
- The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
- reporting Status
- POSTED
- time Frame
- Baseline, month 6
- title
- PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice