Description:

Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Keywords:
Versions (2) ▾
  1. 3/4/19
  2. 10/30/19
Copyright Holder:
GlaxoSmithKline
Uploaded on:

October 30, 2019

DOI:
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License:
Creative Commons BY-NC 3.0
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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556

Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

Administrative
Visit Date
Was a physical examination performed?
Was a physical examination performed?
Physical Examination
Clinical Assessment
Physical Findings
Vital Signs
Were vital signs assessed?
Position
mmHg
mmHg
beats/min
breaths/min
Temperature Unit
Weight Unit
12-Lead ECG
Was a 12-lead ECG performed?
Position
ECG Results
beats/min
msec
msec
msec
msec
QTc Formula
ECG Findings
ECG Findings
Hematology
Was sampling performed?
Hematology
Parameter
Finding
Not Done
Clinical Chemistry, Coagulation and Electrolytes
Was sampling performed?
Clinical Chemistry, Coagulation and Electrolytes
Parameter
Finding
Not Done
Urinalysis dipstick results
Was sampling performed?
pH
Glucose (mmol/L)
Blood
Protein (g/L)
Leucocytes
Urinalysis microscopy results
Was sampling performed?
Urinalysis microscopy results
Parameter
Not Done
Clinically significant?
Serum beta-hCG Pregnancy Test
Is the subject female of child-bearing potential?
Has a serum β-hCG pregnancy test been performed?
Result of pregnancy test
PK Sampling - Plasma Samples
Check if Not Applicable
Check if Not Done
Study Treatment Compliance (Return)
Has the subject returned their diary card?
Has the subject received SRT501 approximately 15-30 minutes following breakfast consumption?
New Adverse Events and Concomitant Treatment
Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?