Prior Cancer and Non-Cancer related surgical procedures - Sequence Number
Item
Prior Cancer and Non-Cancer related surgical procedures - Sequence Number
integer
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - Specific Procedure
Item
Prior Cancer and Non-Cancer related surgical procedures - Specific Procedure
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - Modified Term
Item
Prior Cancer and Non-Cancer related surgical procedures - Modified Term
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C2826302 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - MedDRA Synonym
Item
Prior Cancer and Non-Cancer related surgical procedures - MedDRA Synonym
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C1140263 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - MedDRA lower level term code
Item
Prior Cancer and Non-Cancer related surgical procedures - MedDRA lower level term code
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C3898442 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - Failed coding
Item
Prior Cancer and Non-Cancer related surgical procedures - Failed coding
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Prior Cancer and Non-Cancer related surgical procedures - Date of Procedure
Item
Prior Cancer and Non-Cancer related surgical procedures - Date of Procedure
date
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C2584899 (UMLS CUI [2])
Item
Prior Cancer and Non-Cancer related surgical procedures - Classification
integer
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C0008902 (UMLS CUI [2])
Code List
Prior Cancer and Non-Cancer related surgical procedures - Classification
CL Item
Cancer related (1)
CL Item
Other (general) (2)
Investigational Product - Sequence Number
Item
Investigational Product - Sequence Number
text
C0304229 (UMLS CUI [1])
C2348184 (UMLS CUI [2])
Investigational Product - Dose start date
Item
Investigational Product - Dose start date
date
C0304229 (UMLS CUI [1])
C0808070 (UMLS CUI [2])
Investigational Product - Dose stop date
Item
Investigational Product - Dose stop date
date
C0304229 (UMLS CUI [1])
C0806020 (UMLS CUI [2])
Investigational Product - Actual Dose
Item
Investigational Product - Actual Dose
integer
C0304229 (UMLS CUI [1])
C3174092 (UMLS CUI [2])
Investigational Product - Was dose delayed?
Item
Investigational Product - Was dose delayed?
boolean
C0304229 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
Item
Investigational Product - If dose was delayed, record the primary reason
integer
C0304229 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Code List
Investigational Product - If dose was delayed, record the primary reason
CL Item
Thrombocytopenia (2)
CL Item
Thrombosis/ embolism (4)
CL Item
Liver dysfunction (7)
CL Item
Antithrombotic medication (11)
CL Item
Other, specify (12)
Investigational Product - If other primary reason for dose was delayed, please specify
Item
Investigational Product - If other reason for dose was delayed, please specify
text
C0304229 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
C1549995 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Investigational Product - Was dose reduced?
Item
Investigational Product - Was dose reduced?
boolean
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Item
Investigational Product - If dose was reduced, record the primary reason
integer
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Code List
Investigational Product - If dose was reduced, record the primary reason
CL Item
Thrombocytopenia (2)
CL Item
Thrombosis/ embolism (4)
CL Item
Live r d ysfu nction (7)
CL Item
Other, specify (11)
Investigational Product - If other reason for dose was reduced, please specify
Item
Investigational Product - If other reason for dose was reduced, please specify
text
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C1549995 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Investigational Product - Was dose escalated?
Item
Investigational Product - Was dose escalated?
boolean
C0304229 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
Item
Investigational Product - If dose was escalated, record the primary reason
integer
C0304229 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Code List
Investigational Product - If dose was escalated, record the primary reason
CL Item
Toxicity resolved (1)
CL Item
Other, specify (3)
Investigational Product - If other reason for dose escalated, please specify
Item
Investigational Product - If other reason for dose escalated, please specify
text
C0304229 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
C1549995 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Investigational Product - Was an anti-hypertension medication added or adjusted?
Item
Investigational Product - Was an anti-hypertension medication added or adjusted?
boolean
C0304229 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0456081 (UMLS CUI [2,3])
Item
Investigational Product - If an anti-hypertension medication was added or adjusted, record the primary reason
integer
C0304229 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0456081 (UMLS CUI [2,3])
C1549995 (UMLS CUI [2,4])
Code List
Investigational Product - If an anti-hypertension medication was added or adjusted, record the primary reason
CL Item
Other, specify (2)
undefined item
Item
Investigational Product - If other reason for anti-hypertension medication was added or adjusted, please specify
text
C0304229 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0456081 (UMLS CUI [2,3])
C1549995 (UMLS CUI [2,4])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Blood Products and Blood Supportive Care Products - Sequence Number
Item
Blood Products and Blood Supportive Care Products - Sequence Number
integer
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2348184 (UMLS CUI [3])
Item
Blood Products and Blood Supportive Care Products
integer
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
Code List
Blood Products and Blood Supportive Care Products
CL Item
Red Blood Cells (1)
CL Item
Cryoprecipitate (6)
CL Item
White Blood Cells (7)
CL Item
Other Blood Product, specify (8)
CL Item
Prophylactic G-CSF (10)
CL Item
Treatment G-CSF (11)
CL Item
Erythropoietin (13)
CL Item
Pegfilgrastim (Conjugated G-CSF/ Neulasta) (14)
CL Item
Oprelvecin (IL-11) (15)
If other Blood Products and Blood Supportive Care Products, please specify
Item
If other Blood Products and Blood Supportive Care Products, please specify
text
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Blood Products and Blood Supportive Care Products - Cumulative Quantitiy or Dose
Item
Blood Products and Blood Supportive Care Products - Cumulative Quantitiy or Dose
integer
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2986497 (UMLS CUI [3])
Cumulative Quantitiy or Dose Units
Item
Cumulative Quantitiy or Dose Units
text
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2986497 (UMLS CUI [3,1])
C1519795 (UMLS CUI [3,2])
Blood Products and Blood Supportive Care Products Start Date
Item
Blood Products and Blood Supportive Care Products Start Date
date
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Blood Products and Blood Supportive Care Products Stop Date
Item
Blood Products and Blood Supportive Care Products Stop Date
date
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Date of visit/ Assessment
Item
Date of visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
100% Random Sample SDV Performed on this Subject visit
integer
C0034656 (UMLS CUI [1])
Code List
100% Random Sample SDV Performed on this Subject visit
Item
List unscheduled assessment(s) performed at this visit by clicking on the appropriate box(es) to enter the details
integer
C0220825 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C3854240 (UMLS CUI [2])
Code List
List unscheduled assessment(s) performed at this visit by clicking on the appropriate box(es) to enter the details
CL Item
UNS LESION ASMT (10)
CL Item
NONTARGET LS (12)
CL Item
NEW LS/OVR RESP (13)
Did the subject have any lesion assessments performed at this visit?
Item
Did the subject have any lesion assessments performed at this visit?
boolean
C0221198 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Is the subject alive?
Item
Is the subject alive?
boolean
C2584946 (UMLS CUI [1])
If subject is alive, complete Date of Contact
Item
If subject is alive, complete Date of Contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Has the subject started any new anti-cancer therapy since the last contact?
Item
Has the subject started any new anti-cancer therapy since the last contact?
boolean
C0920425 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1705415 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
Has the subject started any new radiation therapy since the last contact?
Item
Has the subject started any new radiation therapy since the last contact?
boolean
C1522449 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1705415 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
Follow-Up Anti-Cancer Therapy Sequence Number
Item
Follow-Up Anti-Cancer Therapy Sequence Number
integer
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Follow-Up Anti-Cancer Therapy - Drug Name
Item
Follow-Up Anti-Cancer Therapy - Drug Name
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2])
Follow-Up Anti-Cancer Therapy - Modified reported term
Item
Follow-Up Anti-Cancer Therapy - Modified reported term
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C2826302 (UMLS CUI [2])
Follow-Up Anti-Cancer Therapy - GSK Drug synonym
Item
Follow-Up Anti-Cancer Therapy - GSK Drug synonym
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
Follow-Up Anti-Cancer Therapy - GSK Drug Collection code
Item
Follow-Up Anti-Cancer Therapy - GSK Drug Collection code
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1516698 (UMLS CUI [2,2])
C0805701 (UMLS CUI [2,3])
Follow-Up Anti-Cancer Therapy - Failed coding
Item
Follow-Up Anti-Cancer Therapy - Failed coding
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Item
Follow-Up Anti-Cancer Therapy - Therapy Type
integer
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
Code List
Follow-Up Anti-Cancer Therapy - Therapy Type
CL Item
Biologic Therapy (antibodies, cytokines) (1)
CL Item
Chemotherapy (cytotoxics, non-cytotoxics) (2)
CL Item
Hormonal Therapy (3)
CL Item
Immunotherapy (4)
Follow-Up Anti-Cancer Therapy - Start Date
Item
Follow-Up Anti-Cancer Therapy - Start Date
date
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
Item
Follow-Up Anti-Cancer Therapy - Best Response
integer
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C2986560 (UMLS CUI [2])
Code List
Follow-Up Anti-Cancer Therapy - Best Response
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
Follow-Up Anti-Cancer Therapy - Duration of Response
Item
Follow-Up Anti-Cancer Therapy - Duration of Response
durationDatetime
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0237585 (UMLS CUI [2])
Follow-Up Anti-Cancer Radiotherapy - Sequence Number
Item
Follow-Up Anti-Cancer Radiotherapy - Sequence Number
integer
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C2348184 (UMLS CUI [2])
Follow-Up Anti-Cancer Radiotherapy - Site
Item
Follow-Up Anti-Cancer Radiotherapy - Site
text
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2])
Follow-Up Anti-Cancer Radiotherapy - Start Date
Item
Follow-Up Anti-Cancer Radiotherapy - Start Date
date
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C0808070 (UMLS CUI [2])
Item
Follow-Up Anti-Cancer Radiotherapy - Best Response
integer
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C2986560 (UMLS CUI [2])
Code List
Follow-Up Anti-Cancer Radiotherapy - Best Response
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Not Evaluable (5)
Follow-Up Anti-Cancer Radiotherapy - Duration of Response
Item
Follow-Up Anti-Cancer Radiotherapy - Duration of Response
durationDatetime
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C0237585 (UMLS CUI [2])