ID

44275

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

  1. 2/24/19 2/24/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

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

Screening - Demography; Inclusion Criteria; Exclusion Criteria

Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date informed consent signed
Description

Date informed consent signed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
If other race, please specify.
Description

If other race, please specify.

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
Description

1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.

Data type

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0021430
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
Description

2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.

Data type

integer

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0162643
3. The subject has measurable disease.
Description

3. The subject has measurable disease.

Data type

integer

Alias
UMLS CUI [1]
C1513041
4. The subject has relapsed or relapsed/refractory disease. This must include at least one of the following criteria: Reappearance of serum or urinary paraprotein on immunofixation or routine electrophoresis confirmed by at least one follow-up and excluding oligoclonal immune reconstitution. ≥5% plasma cells in the bone marrow aspirate or biopsy. Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (not including compression fracture). Development of hypercalcemia (corrected serum calcium >11.5mg/dL or 2.8 mmol/L not attributable to any other cause)
Description

4. The subject has relapsed or relapsed/refractory disease

Data type

integer

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0205269
5. The subject has a life expectancy of greater than 6 months.
Description

5. The subject has a life expectancy of greater than 6 months.

Data type

integer

Alias
UMLS CUI [1]
C0023671
6. The subject has an ECOG Performance status of 0 to 2.
Description

6. The subject has an ECOG Performance status of 0 to 2.

Data type

integer

Alias
UMLS CUI [1]
C1520224
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
Description

7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.

Data type

integer

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
Description

8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C0205161
UMLS CUI [2,3]
C2826293
9. The subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
Description

9. The subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.

Data type

integer

Alias
UMLS CUI [1]
C0565998
UMLS CUI [2,1]
C2700391
UMLS CUI [2,2]
C1507394
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
Description

10. The subject must be able to adhere to the study visit schedule and other protocol requirements.

Data type

integer

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1512346
UMLS CUI [1,5]
C0086960
UMLS CUI [1,6]
C1709747
11. The subject must understand and voluntarily sign an informed consent document.
Description

11. The subject must understand and voluntarily sign an informed consent document.

Data type

integer

Alias
UMLS CUI [1]
C0021430
12. If the subject is of reproductive potential, the subject must agree prior to study entry to use ad equate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.
Description

12. If the subject is of reproductive potential, the subject must agree prior to study entry to use ad equate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.

Data type

integer

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
13. The subject must have Adequate end organ function, defined as the following: • Total bilirubin ≤ 2 x ULN, unless attributable to Gilbert’s disease • ALT (SGPT) and AST (SGOT) ≤ 2.5 x ULN • Creatinine < 2.0 x ULN • ANC ≥ 0.5 x 10 9 /L • Platelets ≥ 20,000 cells/mm 3
Description

13. The subject must have Adequate end organ function

Data type

integer

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0948762
UMLS CUI [7]
C0005821
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. The subject has intolerance to resveratrol, SRT501 or bortezomib or significant allergy to either compound, boron or mannitol or significant prior toxicity with either agent that would preclude the safe use of that agent. Prior therapy with either compound is permitted.
Description

1. Intolerance to resveratrol, SRT501, bortezomib, Boron, Mannitol or prior toxicity

Data type

integer

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0073096
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C2002402
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C1176309
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0006030
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0024730
UMLS CUI [6]
C0013221
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
Description

2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.

Data type

integer

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0007117
UMLS CUI [1,4]
C0553723
3. The subject has an uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

3. The subject has an uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.

Data type

integer

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C1735346
UMLS CUI [7]
C0265122
UMLS CUI [8]
C0004936
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
Description

4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.

Data type

integer

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0678745
5. If female, the subject is breast-feeding, pregnant, expects to become pregnant during the course of the study, or are sexually active in a heterosexual relationship and are not using a medically acceptable double barrier method birth control. Confirmation that the subject is not pregnant must be established by a negative serum β-hCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Women relying solely on oral contraceptives for birth control are excluded.
Description

5. Breast Feeding | Pregnancy | Sex Behavior | Contraceptive methods; Appropriate | Serum pregnancy test negative; Serum Beta-HCG Test | Postmenopausal state | Female Sterilization

Data type

integer

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0036864
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1548787
UMLS CUI [5,1]
C0430061
UMLS CUI [5,2]
C1255526
UMLS CUI [6]
C0232970
UMLS CUI [7]
C0015787
6. The subject has had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Description

6. The subject has had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Data type

integer

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021430
UMLS CUI [4]
C0877248
7. The subject is on concurrent medications that may exhibit anti-neoplastic therapy, with the exception of ≤10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.
Description

7. The subject is on concurrent medications that may exhibit anti-neoplastic therapy, with the exception of ≤10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.

Data type

integer

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C2827774
UMLS CUI [2]
C0032952
UMLS CUI [3]
C0020268
UMLS CUI [4]
C0456388
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
Description

8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.

Data type

integer

Alias
UMLS CUI [1]
C0242295
UMLS CUI [2]
C0949266
UMLS CUI [3]
C0073096
9. The subject has peripheral neuropathy of Grade 2 or greater.
Description

9. The subject has peripheral neuropathy of Grade 2 or greater.

Data type

integer

Alias
UMLS CUI [1]
C0031117
10. The subject has uncontrolled bleeding.
Description

10. The subject has uncontrolled bleeding.

Data type

integer

Alias
UMLS CUI [1]
C0019080
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory. (i.e.,unable to maintain a platelet count ≥ 20,000 cells/mm3).
Description

11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory.

Data type

integer

Alias
UMLS CUI [1]
C2748540
UMLS CUI [2]
C1390214
UMLS CUI [3]
C0005821
12. The subject has a hemoglobin level less than < 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.
Description

12. The subject has a hemoglobin level less than < 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.

Data type

integer

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C1879316
UMLS CUI [3]
C0014822
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
Description

13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.

Data type

integer

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1853129

Similar models

Screening - Demography; Inclusion Criteria; Exclusion Criteria

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date informed consent signed
Item
Date informed consent signed
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
Afro-Caribbean  (1)
CL Item
Caucasian  (2)
CL Item
Asian (3)
CL Item
Other, specify (4)
If other race, please specify.
Item
If other race, please specify.
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Item
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
integer
C0001779 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Code List
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
integer
C0026764 (UMLS CUI [1])
C0162643 (UMLS CUI [2])
Code List
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
3. The subject has measurable disease.
integer
C1513041 (UMLS CUI [1])
Code List
3. The subject has measurable disease.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
4. The subject has relapsed or relapsed/refractory disease. This must include at least one of the following criteria: Reappearance of serum or urinary paraprotein on immunofixation or routine electrophoresis confirmed by at least one follow-up and excluding oligoclonal immune reconstitution. ≥5% plasma cells in the bone marrow aspirate or biopsy. Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (not including compression fracture). Development of hypercalcemia (corrected serum calcium >11.5mg/dL or 2.8 mmol/L not attributable to any other cause)
integer
C0277556 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Code List
4. The subject has relapsed or relapsed/refractory disease. This must include at least one of the following criteria: Reappearance of serum or urinary paraprotein on immunofixation or routine electrophoresis confirmed by at least one follow-up and excluding oligoclonal immune reconstitution. ≥5% plasma cells in the bone marrow aspirate or biopsy. Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (not including compression fracture). Development of hypercalcemia (corrected serum calcium >11.5mg/dL or 2.8 mmol/L not attributable to any other cause)
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
5. The subject has a life expectancy of greater than 6 months.
integer
C0023671 (UMLS CUI [1])
Code List
5. The subject has a life expectancy of greater than 6 months.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
6. The subject has an ECOG Performance status of 0 to 2.
integer
C1520224 (UMLS CUI [1])
Code List
6. The subject has an ECOG Performance status of 0 to 2.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
integer
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Code List
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
integer
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Code List
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
9. The subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
integer
C0565998 (UMLS CUI [1])
C2700391 (UMLS CUI [2,1])
C1507394 (UMLS CUI [2,2])
Code List
9. The subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
integer
C0085732 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1512346 (UMLS CUI [1,4])
C0086960 (UMLS CUI [1,5])
C1709747 (UMLS CUI [1,6])
Code List
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
11. The subject must understand and voluntarily sign an informed consent document.
integer
C0021430 (UMLS CUI [1])
Code List
11. The subject must understand and voluntarily sign an informed consent document.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
12. If the subject is of reproductive potential, the subject must agree prior to study entry to use ad equate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.
integer
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Code List
12. If the subject is of reproductive potential, the subject must agree prior to study entry to use ad equate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
13. The subject must have Adequate end organ function, defined as the following: • Total bilirubin ≤ 2 x ULN, unless attributable to Gilbert’s disease • ALT (SGPT) and AST (SGOT) ≤ 2.5 x ULN • Creatinine < 2.0 x ULN • ANC ≥ 0.5 x 10 9 /L • Platelets ≥ 20,000 cells/mm 3
integer
C0678852 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0005821 (UMLS CUI [7])
Code List
13. The subject must have Adequate end organ function, defined as the following: • Total bilirubin ≤ 2 x ULN, unless attributable to Gilbert’s disease • ALT (SGPT) and AST (SGOT) ≤ 2.5 x ULN • Creatinine < 2.0 x ULN • ANC ≥ 0.5 x 10 9 /L • Platelets ≥ 20,000 cells/mm 3
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Item
1. The subject has intolerance to resveratrol, SRT501 or bortezomib or significant allergy to either compound, boron or mannitol or significant prior toxicity with either agent that would preclude the safe use of that agent. Prior therapy with either compound is permitted.
integer
C1744706 (UMLS CUI [1,1])
C0073096 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2002402 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1176309 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0006030 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0024730 (UMLS CUI [5,2])
C0013221 (UMLS CUI [6])
Code List
1. The subject has intolerance to resveratrol, SRT501 or bortezomib or significant allergy to either compound, boron or mannitol or significant prior toxicity with either agent that would preclude the safe use of that agent. Prior therapy with either compound is permitted.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
integer
C0006826 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0007117 (UMLS CUI [1,3])
C0553723 (UMLS CUI [1,4])
Code List
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
3. The subject has an uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.
integer
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C1735346 (UMLS CUI [6])
C0265122 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
Code List
3. The subject has an uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
integer
C0017178 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
Code List
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
5. If female, the subject is breast-feeding, pregnant, expects to become pregnant during the course of the study, or are sexually active in a heterosexual relationship and are not using a medically acceptable double barrier method birth control. Confirmation that the subject is not pregnant must be established by a negative serum β-hCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Women relying solely on oral contraceptives for birth control are excluded.
integer
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0036864 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C0430061 (UMLS CUI [5,1])
C1255526 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6])
C0015787 (UMLS CUI [7])
Code List
5. If female, the subject is breast-feeding, pregnant, expects to become pregnant during the course of the study, or are sexually active in a heterosexual relationship and are not using a medically acceptable double barrier method birth control. Confirmation that the subject is not pregnant must be established by a negative serum β-hCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Women relying solely on oral contraceptives for birth control are excluded.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
6. The subject has had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
integer
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0877248 (UMLS CUI [4])
Code List
6. The subject has had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
7. The subject is on concurrent medications that may exhibit anti-neoplastic therapy, with the exception of ≤10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.
integer
C0003392 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2])
C0020268 (UMLS CUI [3])
C0456388 (UMLS CUI [4])
Code List
7. The subject is on concurrent medications that may exhibit anti-neoplastic therapy, with the exception of ≤10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
integer
C0242295 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0073096 (UMLS CUI [3])
Code List
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
9. The subject has peripheral neuropathy of Grade 2 or greater.
integer
C0031117 (UMLS CUI [1])
Code List
9. The subject has peripheral neuropathy of Grade 2 or greater.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
10. The subject has uncontrolled bleeding.
integer
C0019080 (UMLS CUI [1])
Code List
10. The subject has uncontrolled bleeding.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory. (i.e.,unable to maintain a platelet count ≥ 20,000 cells/mm3).
integer
C2748540 (UMLS CUI [1])
C1390214 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
Code List
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory. (i.e.,unable to maintain a platelet count ≥ 20,000 cells/mm3).
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
12. The subject has a hemoglobin level less than < 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.
integer
C0019046 (UMLS CUI [1])
C1879316 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
Code List
12. The subject has a hemoglobin level less than < 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
integer
C0012634 (UMLS CUI [1])
C1853129 (UMLS CUI [2])
Code List
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)

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