TriangleNCT00958841 · OUTCOME
Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- 6 months
What was measured
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
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. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.
Groups in this outcome
Gastrinoma
One of the 10 types of PNETs analyzed
VIpoma
One of the 10 types of PNETs analyzed.
Glucagonoma
One of the 10 types of PNETs analyzed.
| Group | Source count |
|---|---|
| Gastrinoma | 13 |
| VIpoma | 2 |
| Glucagonoma | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gastrinoma | 46.2 | Not reported | Not reported | Not reported | Not reported |
| VIpoma | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Glucagonoma | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 46.2
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
- groups
- description
- One of the 10 types of PNETs analyzed
- id
- OG000
- title
- Gastrinoma
- description
- One of the 10 types of PNETs analyzed.
- id
- OG001
- title
- VIpoma
- description
- One of the 10 types of PNETs analyzed.
- id
- OG002
- title
- Glucagonoma
- 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. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice