TriangleNCT00412061 · OUTCOME
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Patients
- Interval / dispersion
- Not reported
- Time frame
- From first day of treatment up to 28 days after last day of treatment in double blind
What was measured
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Analysis population: The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.
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 | 215 |
| Octreotide+ Placebo | 211 |
Reported measurements
Clinically notable AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 208 | Not reported | Not reported | Not reported | Not reported |
| Octreotide+ Placebo | 146 | Not reported | Not reported | Not reported | Not reported |
Grade 3-4 Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 162 | Not reported | Not reported | Not reported | Not reported |
| Octreotide+ Placebo | 109 | Not reported | Not reported | Not reported | Not reported |
On treatment death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 19 | Not reported | Not reported | Not reported | Not reported |
| Octreotide+ Placebo | 11 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Octreotide+ Everolimus | 126 | Not reported | Not reported | Not reported | Not reported |
| Octreotide+ Placebo | 74 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 208
- group Id
- OG001
- value
- 146
- title
- Clinically notable AE
- categories
- measurements
- group Id
- OG000
- value
- 162
- group Id
- OG001
- value
- 109
- title
- Grade 3-4 Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 11
- title
- On treatment death
- categories
- measurements
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 74
- title
- Serious adverse events
- denoms
- counts
- group Id
- OG000
- value
- 215
- group Id
- OG001
- value
- 211
- units
- Participants
- description
- AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
- 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
- NUMBER
- population Description
- The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.
- reporting Status
- POSTED
- time Frame
- From first day of treatment up to 28 days after last day of treatment in double blind
- title
- Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)
- type
- SECONDARY
- unit Of Measure
- Patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice