ID

30306

Beschreibung

https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Link

https://clinicaltrials.gov/ct2/show/NCT00486954

Stichworte

Versionen (1)
  1. 28.05.18 28.05.18 - Halim Ugurlu
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

28. Mai 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

Englisch

Screening-2 (disease, status, anti-cancer therapy, cancer related therapies)

1 Formulare  
Disease Characteristics
Beschreibung

Disease Characteristics

Alias
UMLS CUI-1
C0599878
Primary Tumor type at Initial diagnosis
Beschreibung

Primary Tumor type at Initial diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0011900
Date of Initial Diagnosis
Beschreibung

Date of Initial Diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0205265
Stage at Initial Diagnosis
Beschreibung

Stage at Initial Diagnosis

Datentyp

integer

Alias
UMLS CUI [1]
C1300072
Histology at initial diagnosis
Beschreibung

Histology at initial diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C3172269
Histological Grade at Initial Diagnosis
Beschreibung

Histological Grade at Initial Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0919553
UMLS CUI [1,2]
C4071762
Date of Staging at Screening
Beschreibung

Date of Staging at Screening

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0027646
Stage at Screening
Beschreibung

Stage at Screening

Datentyp

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0220908
Histologic grade at screening
Beschreibung

Histologic grade at screening

Datentyp

integer

Alias
UMLS CUI [1,1]
C0919553
UMLS CUI [1,2]
C0220908
Disease Characteristics (Metastasis)
Beschreibung

Disease Characteristics (Metastasis)

Alias
UMLS CUI-1
C0599878
UMLS CUI-2
C0027627
Metastatic Disease at Screening
Beschreibung

Metastatic Disease at Screening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C0220908
Metastasis Abdomen/Abdominal Wall
Beschreibung

Metastasis Abdomen/Abdominal Wall

Datentyp

integer

Alias
UMLS CUI [1,1]
C0836916
UMLS CUI [1,2]
C0036525
Metastasis Adrenals
Beschreibung

Metastasis Adrenals

Datentyp

integer

Alias
UMLS CUI [1,1]
C0001625
UMLS CUI [1,2]
C0036525
Metastasis Bladder
Beschreibung

Metastasis Bladder

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005682
UMLS CUI [1,2]
C0036525
Metastasis Blood
Beschreibung

Metastasis Blood

Datentyp

integer

Alias
UMLS CUI [1,1]
C0229664
UMLS CUI [1,2]
C0036525
Metastasis Bone
Beschreibung

Metastasis Bone

Datentyp

integer

Alias
UMLS CUI [1]
C0153690
Metastasis Bone Marrow
Beschreibung

Metastasis Bone Marrow

Datentyp

integer

Alias
UMLS CUI [1]
C0346979
Metastasis Breast
Beschreibung

Metastasis Breast

Datentyp

integer

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0036525
Metastasis Cervix
Beschreibung

Metastasis Cervix

Datentyp

integer

Alias
UMLS CUI [1,1]
C0007874
UMLS CUI [1,2]
C0036525
Metastasis Chest Wall
Beschreibung

Metastasis Chest Wall

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205076
UMLS CUI [1,2]
C0036525
Metastasis CNS
Beschreibung

Metastasis CNS

Datentyp

integer

Alias
UMLS CUI [1]
C0686377
Metastasis Colon
Beschreibung

Metastasis Colon

Datentyp

integer

Alias
UMLS CUI [1,1]
C0009368
UMLS CUI [1,2]
C0036525
Metastasis Esophagus/Oesophagus
Beschreibung

Metastasis Esophagus/Oesophagus

Datentyp

integer

Alias
UMLS CUI [1,1]
C0014876
UMLS CUI [1,2]
C0036525
Metastasis Head and Neck
Beschreibung

Metastasis Head and Neck

Datentyp

integer

Alias
UMLS CUI [1,1]
C0460004
UMLS CUI [1,2]
C0036525
Metastasis Heart
Beschreibung

Metastasis Heart

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0036525
Metastasis Kidney
Beschreibung

Metastasis Kidney

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C0036525
Metastasis Liver
Beschreibung

Metastasis Liver

Datentyp

integer

Alias
UMLS CUI [1]
C0494165
Metastasis Lung
Beschreibung

Metastasis Lung

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0036525
Metastasis Lymph Nodes
Beschreibung

Metastasis Lymph Nodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0036525
Metastasis Oral Cavity
Beschreibung

Metastasis Oral Cavity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0226896
UMLS CUI [1,2]
C0036525
Metastasis Ovary
Beschreibung

Metastasis Ovary

Datentyp

integer

Alias
UMLS CUI [1,1]
C0029939
UMLS CUI [1,2]
C0036525
Metastasis Pancreas
Beschreibung

Metastasis Pancreas

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030274
UMLS CUI [1,2]
C0036525
Metastasis Peritoneum
Beschreibung

Metastasis Peritoneum

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031153
UMLS CUI [1,2]
C0036525
Metastasis Pleura
Beschreibung

Metastasis Pleura

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032225
UMLS CUI [1,2]
C0036525
Metastasis Prostate
Beschreibung

Metastasis Prostate

Datentyp

integer

Alias
UMLS CUI [1,1]
C0033572
UMLS CUI [1,2]
C0036525
Metastasis Rectum
Beschreibung

Metastasis Rectum

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034896
UMLS CUI [1,2]
C0036525
Metastasis Skin
Beschreibung

Metastasis Skin

Datentyp

integer

Alias
UMLS CUI [1]
C0153687
Metastasis Small Intestine
Beschreibung

Metastasis Small Intestine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021852
UMLS CUI [1,2]
C0036525
Metastasis Spleen
Beschreibung

Metastasis Spleen

Datentyp

integer

Alias
UMLS CUI [1,1]
C0037993
UMLS CUI [1,2]
C0036525
Metastasis Testicle
Beschreibung

Metastasis Testicle

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039597
UMLS CUI [1,2]
C0036525
Metastasis Thyroid
Beschreibung

Metastasis Thyroid

Datentyp

integer

Alias
UMLS CUI [1,1]
C0040132
UMLS CUI [1,2]
C0036525
Metastasis-Other
Beschreibung

Metastasis-Other

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205394
Status
Beschreibung

Status

Alias
UMLS CUI-1
C0449438
Has the subject had any anti-cancer medical therapies?
Beschreibung

anti-cancer medical therapies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0920425
Has the subject had any anti-cancer radiotherapies?
Beschreibung

anti-cancer radiotherapies

Datentyp

boolean

Alias
UMLS CUI [1]
C0279134
Does the subject have any cancer related current medical conditions?
Beschreibung

cancer related current medical conditions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0006826
Does the subject have any non-cancer related current medical conditions?
Beschreibung

non-cancer related current medical conditions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0445356
Prior Anti-cancer therapy
Beschreibung

Prior Anti-cancer therapy

Alias
UMLS CUI-1
C0920425
UMLS CUI-2
C1514463
Drug name
Beschreibung

trade name preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Regiment Sequence
Beschreibung

Regiment Sequence

Datentyp

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0013227
Therapy Type
Beschreibung

Therapy Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332307
Cumulative Dose of Anthracyclines
Beschreibung

Cumulative Dose of Anthracyclines

Datentyp

text

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0282564
Intent
Beschreibung

Intent

Datentyp

integer

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1301732
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Prior Anti-cancer Radiotherapy
Beschreibung

Prior Anti-cancer Radiotherapy

Alias
UMLS CUI-1
C0279134
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C1515974
Cumulative Dose
Beschreibung

Cumulative Dose

Datentyp

text

Alias
UMLS CUI [1]
C2986497
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1,1]
C0439148
UMLS CUI [1,2]
C0034619
Intent
Beschreibung

Intent

Datentyp

integer

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1301732
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Cancer Related Surgical Procedures
Beschreibung

Cancer Related Surgical Procedures

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C2826292
Gastrectomy
Beschreibung

Gastrectomy

Datentyp

integer

Alias
UMLS CUI [1]
C0017118
If yes to gastrectomy
Beschreibung

If yes to gastrectomy

Datentyp

integer

Alias
UMLS CUI [1]
C0017118
UMLS CUI [2]
C0030600
Date of procedure
Beschreibung

Date of procedure

Datentyp

date

Alias
UMLS CUI [1]
C2584899
Cancer Related Current Medical Conditions
Beschreibung

Cancer Related Current Medical Conditions

Alias
UMLS CUI-1
C3899485
UMLS CUI-2
C0678226
UMLS CUI-3
C0006826
Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Status, current?
Beschreibung

Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0521116
Classification code
Beschreibung

Classification code

Datentyp

text

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0805701
NCI CTCAE
Beschreibung

NCI CTCAE

Datentyp

text

Alias
UMLS CUI [1]
C3887242
Non-Cancer Related Current Medical Conditions
Beschreibung

Non-Cancer Related Current Medical Conditions

Alias
UMLS CUI-1
C3899485
UMLS CUI-2
C3640974
UMLS CUI-3
C0678226
UMLS CUI-4
C0006826
Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Status, current?
Beschreibung

Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0521116
Classification code
Beschreibung

Classification code

Datentyp

text

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0805701
NCI CTCAE
Beschreibung

NCI CTCAE

Datentyp

text

Alias
UMLS CUI [1]
C3887242
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual Date
Beschreibung

Actual Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure
Beschreibung

Blood Pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • C
Alias
UMLS CUI [1]
C0005903
C
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Ähnliche Modelle

Screening-2 (disease, status, anti-cancer therapy, cancer related therapies)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Disease Characteristics
C0599878 (UMLS CUI-1)
Item
Primary Tumor type at Initial diagnosis
text
C0677930 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Primary Tumor type at Initial diagnosis
Code List
Primary Tumor type at Initial diagnosis
CL Item
Stomach (1)
CL Item
Other, specify (2)
Date of Initial Diagnosis
Item
Date of Initial Diagnosis
date
C2316983 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Item
Stage at Initial Diagnosis
integer
C1300072 (UMLS CUI [1])
Stage at Initial Diagnosis
Code List
Stage at Initial Diagnosis
CL Item
1a (1)
CL Item
1b (2)
CL Item
2 (3)
CL Item
3a (4)
CL Item
3b (5)
CL Item
4 (6)
Item
Histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
Histology at initial diagnosis
Code List
Histology at initial diagnosis
CL Item
Papillary Adenocarcinoma (11)
CL Item
Adenosquamous carcinoma (41)
CL Item
Poorly Differentiated adenocarcinoma (48)
CL Item
Signet-Ring cell carcinoma (49)
CL Item
Mucinous adenocarcinoma (50)
CL Item
Carcinoid Tumor (51)
CL Item
Squamoz Cell carcinoma (7)
CL Item
Tubular adenocarcinoma (9)
CL Item
Other, specify (OT)
Item
Histological Grade at Initial Diagnosis
integer
C0919553 (UMLS CUI [1,1])
C4071762 (UMLS CUI [1,2])
Histological Grade at Initial Diagnosis
Code List
Histological Grade at Initial Diagnosis
CL Item
Grade cannot be assessed (0)
CL Item
Well differentiated (1)
CL Item
Moderetely Differentiated (2)
CL Item
Poorly Differentiated (3)
CL Item
Undifferentiated (4)
Date of Staging at Screening
Item
Date of Staging at Screening
date
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
Item
Stage at Screening
integer
C1300072 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Stage at Screening
Code List
Stage at Screening
CL Item
1a (1)
CL Item
1b (2)
CL Item
2 (3)
CL Item
3a (4)
CL Item
3b (5)
CL Item
4 (6)
Item
Histologic grade at screening
integer
C0919553 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Histologic grade at screening
Code List
Histologic grade at screening
CL Item
Grade cannot be assessed (0)
CL Item
Well differentiated (1)
CL Item
Moderetely Differentiated (2)
CL Item
Poorly Differentiated (3)
CL Item
Undifferentiated (4)
Item Group
Disease Characteristics (Metastasis)
C0599878 (UMLS CUI-1)
C0027627 (UMLS CUI-2)
Metastatic Disease at Screening
Item
Metastatic Disease at Screening
boolean
C2939420 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Item
Metastasis Abdomen/Abdominal Wall
integer
C0836916 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Abdomen/Abdominal Wall
Code List
Metastasis Abdomen/Abdominal Wall
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Adrenals
integer
C0001625 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Adrenals
Code List
Metastasis Adrenals
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Bladder
integer
C0005682 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Bladder
Code List
Metastasis Bladder
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Blood
integer
C0229664 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Blood
Code List
Metastasis Blood
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Bone
integer
C0153690 (UMLS CUI [1])
Metastasis Bone
Code List
Metastasis Bone
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Bone Marrow
integer
C0346979 (UMLS CUI [1])
Metastasis Bone Marrow
Code List
Metastasis Bone Marrow
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Breast
integer
C0678222 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Breast
Code List
Metastasis Breast
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Cervix
integer
C0007874 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Cervix
Code List
Metastasis Cervix
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Chest Wall
integer
C0205076 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Chest Wall
Code List
Metastasis Chest Wall
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis CNS
integer
C0686377 (UMLS CUI [1])
Metastasis CNS
Code List
Metastasis CNS
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Colon
integer
C0009368 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Colon
Code List
Metastasis Colon
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Esophagus/Oesophagus
integer
C0014876 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Esophagus/Oesophagus
Code List
Metastasis Esophagus/Oesophagus
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Head and Neck
integer
C0460004 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Head and Neck
Code List
Metastasis Head and Neck
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Heart
integer
C0018787 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Heart
Code List
Metastasis Heart
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Kidney
integer
C0022646 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Kidney
Code List
Metastasis Kidney
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Liver
integer
C0494165 (UMLS CUI [1])
Metastasis Liver
Code List
Metastasis Liver
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Lung
integer
C0024109 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Lung
Code List
Metastasis Lung
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Lymph Nodes
integer
C0024204 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Lymph Nodes
Code List
Metastasis Lymph Nodes
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Oral Cavity
integer
C0226896 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Oral Cavity
Code List
Metastasis Oral Cavity
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Ovary
integer
C0029939 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Ovary
Code List
Metastasis Ovary
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Pancreas
integer
C0030274 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Pancreas
Code List
Metastasis Pancreas
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Peritoneum
integer
C0031153 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Peritoneum
Code List
Metastasis Peritoneum
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Pleura
integer
C0032225 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Pleura
Code List
Metastasis Pleura
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Prostate
integer
C0033572 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Prostate
Code List
Metastasis Prostate
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Rectum
integer
C0034896 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Rectum
Code List
Metastasis Rectum
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Skin
integer
C0153687 (UMLS CUI [1])
Metastasis Skin
Code List
Metastasis Skin
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Small Intestine
integer
C0021852 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Small Intestine
Code List
Metastasis Small Intestine
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Spleen
integer
C0037993 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Spleen
Code List
Metastasis Spleen
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Testicle
integer
C0039597 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Testicle
Code List
Metastasis Testicle
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis Thyroid
integer
C0040132 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Metastasis Thyroid
Code List
Metastasis Thyroid
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Assessed (3)
Item
Metastasis-Other
integer
C0027627 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Metastasis-Other
Code List
Metastasis-Other
CL Item
Not Assessed (1)
CL Item
No (2)
CL Item
Yes, please specify (3)
Item Group
Status
C0449438 (UMLS CUI-1)
anti-cancer medical therapies
Item
Has the subject had any anti-cancer medical therapies?
boolean
C0205156 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
anti-cancer radiotherapies
Item
Has the subject had any anti-cancer radiotherapies?
boolean
C0279134 (UMLS CUI [1])
cancer related current medical conditions
Item
Does the subject have any cancer related current medical conditions?
boolean
C3899485 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
non-cancer related current medical conditions
Item
Does the subject have any non-cancer related current medical conditions?
boolean
C3899485 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0445356 (UMLS CUI [1,3])
Item Group
Prior Anti-cancer therapy
C0920425 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Regiment Sequence
Item
Regiment Sequence
text
C2348184 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Therapy Type
text
C0087111 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Therapy Type
Code List
Therapy Type
CL Item
Biologic therapy (antibodies, cytokines) (1)
CL Item
Chemotherapy (cytotoxics, non-cytotoxics) (2)
CL Item
Immunotherapy (3)
Cumulative Dose of Anthracyclines
Item
Cumulative Dose of Anthracyclines
text
C2986497 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
Item
Intent
integer
C1283828 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Intent
Code List
Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or metastatic (3)
CL Item
local/regional (4)
CL Item
Maintenance (12)
CL Item
not Applicable (0)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Prior Anti-cancer Radiotherapy
C0279134 (UMLS CUI-1)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Cumulative Dose
Item
Cumulative Dose
text
C2986497 (UMLS CUI [1])
Units
Item
Units
text
C0439148 (UMLS CUI [1,1])
C0034619 (UMLS CUI [1,2])
Item
Intent
integer
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Intent
Code List
Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or metastatic (3)
CL Item
Local/REgional (4)
CL Item
Prophylactic (5)
CL Item
Palliative (7)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Cancer Related Surgical Procedures
C0543467 (UMLS CUI-1)
C2826292 (UMLS CUI-2)
Item
Gastrectomy
integer
C0017118 (UMLS CUI [1])
Gastrectomy
Code List
Gastrectomy
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
If yes to gastrectomy
integer
C0017118 (UMLS CUI [1])
C0030600 (UMLS CUI [2])
If yes to gastrectomy
Code List
If yes to gastrectomy
CL Item
Partial gastrectomy (pybrus spared) (1)
CL Item
Total/partial gastrectomy (pylorus removed) (2)
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1])
Item Group
Cancer Related Current Medical Conditions
C3899485 (UMLS CUI-1)
C0678226 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Status
Item
Status, current?
boolean
C0521116 (UMLS CUI [1])
Item
Classification code
text
C0008902 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Classification code
Code List
Classification code
CL Item
Cancer related (24)
CL Item
Toxicities related to previous therapy (29)
CL Item
Other (general) (OT)
Item
NCI CTCAE
text
C3887242 (UMLS CUI [1])
NCI CTCAE
Code List
NCI CTCAE
CL Item
grade 1 (1)
CL Item
grade 2 (2)
CL Item
grade 3 (3)
CL Item
grade 4 (4)
CL Item
not Applicable (X)
Item Group
Non-Cancer Related Current Medical Conditions
C3899485 (UMLS CUI-1)
C3640974 (UMLS CUI-2)
C0678226 (UMLS CUI-3)
C0006826 (UMLS CUI-4)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Status
Item
Status, current?
boolean
C0521116 (UMLS CUI [1])
Item
Classification code
text
C0008902 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Classification code
Code List
Classification code
CL Item
Cancer related (24)
CL Item
Toxicities related to previous therapy (29)
CL Item
Other (general) (OT)
Item
NCI CTCAE
text
C3887242 (UMLS CUI [1])
NCI CTCAE
Code List
NCI CTCAE
CL Item
grade 1 (1)
CL Item
grade 2 (2)
CL Item
grade 3 (3)
CL Item
grade 4 (4)
CL Item
not Applicable (X)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual Date
Item
Actual Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
text
C0005823 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
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