NCT00920556 · OUTCOME
Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets
A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma · Source last updated 2019-02-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- 10^9 cells per liter (L)
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
What was measured
Blood samples collected to evaluate the hematology parameters were WBC count, neutrophils, lymphocytes and platelets. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.
Analysis population: Safety Population. Only those participants available at the specified timepoints were analyzed.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| SRT501 Monotherapy | 24 |
|---|
| SRT501 + Bortezomib | 9 |
|---|
Reported measurements
WBC count
Analysis denominator · Participants
| Group | Source count |
|---|
| SRT501 Monotherapy | 21 |
|---|
| SRT501 + Bortezomib | 9 |
|---|
Values in 10^9 cells per liter (L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SRT501 Monotherapy | 0.55 | 2.76 | Not reported | Not reported | Not reported |
|---|
| SRT501 + Bortezomib | 0.07 | 1.48 | Not reported | Not reported | Not reported |
|---|
Neutrophils
Analysis denominator · Participants
| Group | Source count |
|---|
| SRT501 Monotherapy | 21 |
|---|
| SRT501 + Bortezomib | 9 |
|---|
Values in 10^9 cells per liter (L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SRT501 Monotherapy | 0.27 | 1.32 | Not reported | Not reported | Not reported |
|---|
| SRT501 + Bortezomib | 0.32 | 1.46 | Not reported | Not reported | Not reported |
|---|
Lymphocytes
Analysis denominator · Participants
| Group | Source count |
|---|
| SRT501 Monotherapy | 21 |
|---|
| SRT501 + Bortezomib | 9 |
|---|
Values in 10^9 cells per liter (L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SRT501 Monotherapy | 0.09 | 1.30 | Not reported | Not reported | Not reported |
|---|
| SRT501 + Bortezomib | -0.34 | 0.30 | Not reported | Not reported | Not reported |
|---|
Platelets
Analysis denominator · Participants
| Group | Source count |
|---|
| SRT501 Monotherapy | 21 |
|---|
| SRT501 + Bortezomib | 9 |
|---|
Values in 10^9 cells per liter (L) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SRT501 Monotherapy | -12.1 | 58.1 | Not reported | Not reported | Not reported |
|---|
| SRT501 + Bortezomib | -9.3 | 66.3 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.76
- value
- 0.55
- group Id
- OG001
- spread
- 1.48
- value
- 0.07
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- WBC count
- categories
- measurements
- group Id
- OG000
- spread
- 1.32
- value
- 0.27
- group Id
- OG001
- spread
- 1.46
- value
- 0.32
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Neutrophils
- categories
- measurements
- group Id
- OG000
- spread
- 1.30
- value
- 0.09
- group Id
- OG001
- spread
- 0.30
- value
- -0.34
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Lymphocytes
- categories
- measurements
- group Id
- OG000
- spread
- 58.1
- value
- -12.1
- group Id
- OG001
- spread
- 66.3
- value
- -9.3
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Platelets
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Blood samples collected to evaluate the hematology parameters were WBC count, neutrophils, lymphocytes and platelets. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Safety Population. Only those participants available at the specified timepoints were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
- title
- Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets
- type
- PRIMARY
- unit Of Measure
- 10^9 cells per liter (L)
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