TriangleNCT00920556 · OUTCOME
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Approximately up to 12 cycles of 3 weeks each
What was measured
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.
Analysis population: Safety Population was defined as all the participants who received any amount of SRT501 or bortezomib.
Groups in this outcome
SRT501 Monotherapy
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
| Group | Source count |
|---|---|
| SRT501 Monotherapy | 24 |
| SRT501 + Bortezomib | 9 |
Reported measurements
Any AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SRT501 Monotherapy | 24 | Not reported | Not reported | Not reported | Not reported |
| SRT501 + Bortezomib | 9 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SRT501 Monotherapy | 12 | Not reported | Not reported | Not reported | Not reported |
| SRT501 + Bortezomib | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 9
- title
- Any AE
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 3
- title
- Any SAE
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.
- groups
- description
- The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
- id
- OG000
- title
- SRT501 Monotherapy
- description
- The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
- id
- OG001
- title
- SRT501 + Bortezomib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population was defined as all the participants who received any amount of SRT501 or bortezomib.
- reporting Status
- POSTED
- time Frame
- Approximately up to 12 cycles of 3 weeks each
- title
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice