TriangleNCT00510068 · OUTCOME
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)
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
- on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation
What was measured
Adverse events 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. Serious adverse events 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 open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.
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 | 225 |
| Placebo | 0 |
Reported measurements
Adverse events (AEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 221 | Not reported | Not reported | Not reported | Not reported |
Death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 122 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 108 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 221
- title
- Adverse events (AEs)
- categories
- measurements
- group Id
- OG000
- value
- 122
- title
- Death
- categories
- measurements
- group Id
- OG000
- value
- 108
- title
- Serious Adverse Events
- denoms
- counts
- group Id
- OG000
- value
- 225
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- Adverse events 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. Serious adverse events 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
- 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
- NUMBER
- population Description
- The open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.
- reporting Status
- POSTED
- time Frame
- on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation
- title
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice