TriangleNCT00510068 · OUTCOME
Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
What was measured
Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be 'Elevated' otherwise considered as "Non-elevated". An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors.
Analysis population: The Full Analysis Set (FAS) consisted of all patients who were randomized.
Groups in this outcome
Everolimus 10 mg/Day
Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
Placebo
Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
| Group | Source count |
|---|---|
| Everolimus 10 mg/Day | 207 |
| Placebo | 203 |
Reported measurements
NSE Levels at baseline: <= ULN (n: 155, 138)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 13.86 | Not reported | 10.81 | 18.10 | Not reported |
| Placebo | 5.36 | Not reported | 3.78 | 5.55 | Not reported |
NSE levels at baseline: > ULN (n: 48, 56)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 8.11 | Not reported | 4.24 | 11.17 | Not reported |
| Placebo | 2.83 | Not reported | 2.60 | 3.06 | Not reported |
Early NSE response: Response (n: 24, 16)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 8.11 | Not reported | 4.24 | 11.40 | Not reported |
| Placebo | 3.06 | Not reported | 2.23 | 5.36 | Not reported |
Early NSE response: Non-Response (n:16, 27)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 3.79 | Not reported | 2.60 | 13.80 | Not reported |
| Placebo | 2.58 | Not reported | 1.84 | 2.83 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.81
- upper Limit
- 18.10
- value
- 13.86
- group Id
- OG001
- lower Limit
- 3.78
- upper Limit
- 5.55
- value
- 5.36
- title
- NSE Levels at baseline: <= ULN (n: 155, 138)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.24
- upper Limit
- 11.17
- value
- 8.11
- group Id
- OG001
- lower Limit
- 2.60
- upper Limit
- 3.06
- value
- 2.83
- title
- NSE levels at baseline: > ULN (n: 48, 56)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.24
- upper Limit
- 11.40
- value
- 8.11
- group Id
- OG001
- lower Limit
- 2.23
- upper Limit
- 5.36
- value
- 3.06
- title
- Early NSE response: Response (n: 24, 16)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.60
- upper Limit
- 13.80
- value
- 3.79
- group Id
- OG001
- lower Limit
- 1.84
- upper Limit
- 2.83
- value
- 2.58
- title
- Early NSE response: Non-Response (n:16, 27)
- denoms
- counts
- group Id
- OG000
- value
- 207
- group Id
- OG001
- value
- 203
- units
- Participants
- description
- Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be 'Elevated' otherwise considered as "Non-elevated". An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
- id
- OG000
- title
- Everolimus 10 mg/Day
- description
- Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- The Full Analysis Set (FAS) consisted of all patients who were randomized.
- reporting Status
- POSTED
- time Frame
- Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
- title
- Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice