TriangleNCT00412061 · OUTCOME
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level
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
- If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
What was measured
5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.
Analysis population: The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.
Groups in this outcome
Octreotide+ Everolimus
Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
Octreotide+ Placebo
Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
| Group | Source count |
|---|---|
| Octreotide+ Everolimus | 187 |
| Octreotide+ Placebo | 191 |
Reported measurements
5-HIAA <=median (n=93,96)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 21.75 | Not reported | 13.93 | NA | Upper Limit was not applicable or computable as median was just reached. |
| Octreotide+ Placebo | 13.90 | Not reported | 8.71 | 22.44 | Not reported |
5-HIAA > median (n=94,95)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 13.83 | Not reported | 10.61 | 18.63 | Not reported |
| Octreotide+ Placebo | 8.41 | Not reported | 8.08 | 11.33 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper Limit was not applicable or computable as median was just reached.
- group Id
- OG000
- lower Limit
- 13.93
- upper Limit
- NA
- value
- 21.75
- group Id
- OG001
- lower Limit
- 8.71
- upper Limit
- 22.44
- value
- 13.90
- title
- 5-HIAA <=median (n=93,96)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.61
- upper Limit
- 18.63
- value
- 13.83
- group Id
- OG001
- lower Limit
- 8.08
- upper Limit
- 11.33
- value
- 8.41
- title
- 5-HIAA > median (n=94,95)
- denoms
- counts
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 191
- units
- Participants
- description
- 5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
- id
- OG000
- title
- Octreotide+ Everolimus
- description
- Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
- id
- OG001
- title
- Octreotide+ Placebo
- param Type
- MEDIAN
- population Description
- The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.
- reporting Status
- POSTED
- time Frame
- If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
- title
- Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice