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NCT00920556 · OUTCOME

Change From in Baseline Biochemistry: Serum Creatinine, Total Bilirubin

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
Micromole per liter
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 were collected to evaluate hematology parameters serum creatinine and total bilirubin. 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 time points 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

GroupSource count
SRT501 Monotherapy24
SRT501 + Bortezomib9

Reported measurements

Serum creatinine

Analysis denominator · Participants

GroupSource count
SRT501 Monotherapy20
SRT501 + Bortezomib9
Values in Micromole per liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SRT501 Monotherapy59.8123.5Not reportedNot reportedNot reported
SRT501 + Bortezomib3.608.41Not reportedNot reportedNot reported
Total bilirubin

Analysis denominator · Participants

GroupSource count
SRT501 Monotherapy19
SRT501 + Bortezomib9
Values in Micromole per liter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SRT501 Monotherapy1.65.65Not reportedNot reportedNot reported
SRT501 + Bortezomib0.802.44Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        123.5
        value
        59.8
      2. group Id
        OG001
        spread
        8.41
        value
        3.60
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Serum creatinine
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.65
        value
        1.6
      2. group Id
        OG001
        spread
        2.44
        value
        0.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Total bilirubin
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Blood samples were collected to evaluate hematology parameters serum creatinine and total bilirubin. 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
  1. 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
  2. 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 time points 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 in Baseline Biochemistry: Serum Creatinine, Total Bilirubin
type
PRIMARY
unit Of Measure
Micromole per liter

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Preserved source evidence · Not medical advice