ID

40266

Description

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the tumor type, disease characteristics and metastatic disease characteristics. It has to be filled in for the Screening visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Keywords

Versions (3)
  1. 3/26/20 3/26/20 - Christian Arras
  2. 3/26/20 3/26/20 - Christian Arras
  3. 3/26/20 3/26/20 - Christian Arras
Copyright Holder

GlaxoSmithKline

Uploaded on

March 26, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

English

Disease characteristics

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
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
Tumor Type
Description

Tumor Type

Alias
UMLS CUI-1
C4263544
Tumor type
Description

Tumor type

Data type

text

Alias
UMLS CUI [1]
C4263544
Disease characteristics
Description

Disease characteristics

Alias
UMLS CUI-1
C0599878
UMLS CUI-2
C0678222
Primary tumor at initial diagnosis
Description

hidden/not required

Data type

integer

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C4071762
Date of initial diagnosis
Description

Date of initial diagnosis

Data type

partialDate

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0205265
TNM Staging at initial diagnosis, primary tumor
Description

TNM Stage at initial diagnosis, primary tumor

Data type

text

Alias
UMLS CUI [1,1]
C4071762
UMLS CUI [1,2]
C0475455
TNM Stage at initial diagnosis, regional lymph nodes
Description

TNM Stage at initial diagnosis, regional lymph nodes

Data type

text

Alias
UMLS CUI [1,1]
C4071762
UMLS CUI [1,2]
C0456532
TNM Stage at initial diagnosis, distant metastasis
Description

TNM Stage at initial diagnosis, distant metastasis

Data type

text

Alias
UMLS CUI [1,1]
C4071762
UMLS CUI [1,2]
C0456533
Histology at initial diagnosis
Description

If Other, specify below

Data type

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C3172269
Other histology at initial diagnosis
Description

Histology at initial diagnosis, other

Data type

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C3172269
UMLS CUI [1,3]
C0205394
Histological Grade at Initial Diagnosis
Description

Histological Grade at Initial Diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0919553
UMLS CUI [1,3]
C4071762
Date of last progression
Description

Date of last progression

Data type

partialDate

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
Date of Staging at Screening
Description

Date of Staging at Screening

Data type

partialDate

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0027646
UMLS CUI [1,3]
C1710477
Stage at Screening
Description

Stage at Screening

Data type

text

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0220908
Extent of Disease at Screening
Description

Extent of Disease at Screening

Data type

text

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0449279
Primary tumor In Situ
Description

Primary tumor In Situ

Data type

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0007099
ErbB2 (Her2/neu) Status
Description

ErbB2 (Her2/neu) Status

Alias
UMLS CUI-1
C1512413
Date of ErbB2 Biopsy
Description

Date of ErbB2 Biopsy

Data type

partialDate

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1512413
UMLS CUI [1,3]
C0011008
Disease Setting for the Biopsy
Description

Disease status for Biopsy

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0005558
ErbB2 (Her2/neu) Status ImmunoHisto-Chemistry (IHC)
Description

ErbB2 (Her2neu) Status IHC

Data type

text

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0021044
Fluorescence in Situ Hybridization (FISH)
Description

Fluorescence in Situ Hybridization (FISH)

Data type

text

Alias
UMLS CUI [1]
C0162789
Chromogenic in Situ Hybridization (CISH)
Description

Chromogenic in Situ Hybridization (CISH)

Data type

text

Alias
UMLS CUI [1]
C1516514
Disease characteristics
Description

Disease characteristics

Alias
UMLS CUI-1
C0599878
UMLS CUI-2
C0205394
UMLS CUI-3
C0006826
Primary tumor at initial diagnosis
Description

hidden/not required, If Other, specify below

Data type

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C4071762
Other Primary tumor at initial diagnosis
Description

hidden/not required,

Data type

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C4071762
UMLS CUI [1,4]
C0205394
Date of initial diagnosis
Description

Date of initial diagnosis

Data type

partialDate

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0205265
TNM Staging at initial diagnosis, primary tumor
Description

TNM Stage at initial diagnosis, primary tumor

Data type

text

Alias
UMLS CUI [1,1]
C4071762
UMLS CUI [1,2]
C0475455
TNM Stage at initial diagnosis, regional lymph nodes
Description

TNM Stage at initial diagnosis, regional lymph nodes

Data type

text

Alias
UMLS CUI [1,1]
C4071762
UMLS CUI [1,2]
C0456532
TNM Stage at initial diagnosis, distant metastasis
Description

TNM Stage at initial diagnosis, distant metastasis

Data type

text

Alias
UMLS CUI [1,1]
C4071762
UMLS CUI [1,2]
C0456533
Histology at initial diagnosis
Description

If Other, specify below

Data type

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C3172269
Other histology at initial diagnosis
Description

Histology at initial diagnosis, other

Data type

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C3172269
UMLS CUI [1,3]
C0205394
Histological Grade at Initial Diagnosis
Description

Histological Grade at Initial Diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0919553
UMLS CUI [1,2]
C4071762
Date of last progression
Description

Date of last progression

Data type

partialDate

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
Date of Staging at Screening
Description

Date of Staging at Screening

Data type

partialDate

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0027646
UMLS CUI [1,3]
C1710477
Stage at Screening
Description

Stage at Screening

Data type

text

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0220908
Extent of Disease at Screening
Description

Extent of Disease at Screening

Data type

text

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0449279
Primary tumor In Situ
Description

Primary tumor In Situ

Data type

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0007099
Metastatic disease characteristics
Description

Metastatic disease characteristics

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

If yes, specify below

Data type

text

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0220908
Metastatic Disease at Screening, Date
Description

initial Neoplasm Metastatis, Date

Data type

partialDate

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0449976
Adrenals
Description

Adrenals metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0001625
UMLS CUI [1,2]
C0027627
Bladder
Description

Bladder metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0005682
UMLS CUI [1,2]
C0027627
Bone
Description

Bone metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0027627
Bone Marrow
Description

Bone Marrow metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0027627
Breast
Description

Breast metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0027627
Chest Wall
Description

Chest Wall metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0205076
UMLS CUI [1,2]
C0027627
CNS
Description

Central nervous system metastasis

Data type

text

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C0027627
Kidney
Description

Kidney metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0022646
UMLS CUI [1,2]
C0027627
Liver
Description

Liver metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0027627
Lung
Description

Lung metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0027627
Lymph nodes
Description

Lymph nodes metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0027627
Ovary
Description

Ovary metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0029939
UMLS CUI [1,2]
C0027627
Peritoneum
Description

Peritoneum metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0031153
UMLS CUI [1,2]
C0027627
Pleura
Description

Pleura metastasis

Data type

text

Alias
UMLS CUI [1,1]
C0032225
UMLS CUI [1,2]
C0027627
Skin
Description

Skin metastasis

Data type

text

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0027627
Other
Description

If Yes, please specify below

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0027627
Other to specify
Description

Other to specify

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
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Similar models

Disease characteristics

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
C4263544 (UMLS CUI-1)
Item
Tumor type
text
C4263544 (UMLS CUI [1])
Tumor type
Code List
Tumor type
CL Item
Breast Cancer  (B)
CL Item
Other solid tumor malignancy (OT)
Item Group
Disease characteristics
C0599878 (UMLS CUI-1)
C0678222 (UMLS CUI-2)
Item
Primary tumor at initial diagnosis
integer
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
Primary tumor type at initial diagnosis
Code List
Primary tumor at initial diagnosis
CL Item
Breast (6)
Date of initial diagnosis
Item
Date of initial diagnosis
partialDate
C2316983 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Item
TNM Staging at initial diagnosis, primary tumor
text
C4071762 (UMLS CUI [1,1])
C0475455 (UMLS CUI [1,2])
TNM Stage at initial diagnosis, primary tumor
Code List
TNM Staging at initial diagnosis, primary tumor
CL Item
T0 (T0)
CL Item
T1 (T1)
CL Item
T1A (T1a)
CL Item
T1B (T1b)
CL Item
T1C (T1c)
CL Item
T2 (T2)
CL Item
T2A (T2a)
CL Item
T2B (T2b)
CL Item
T2C (T2c)
CL Item
T3 (T3)
CL Item
T3A (T3a)
CL Item
T3B (T3b)
CL Item
T3C (T3c)
CL Item
T4 (T4)
CL Item
TIS (TIS)
CL Item
TX (TX)
Item
TNM Stage at initial diagnosis, regional lymph nodes
text
C4071762 (UMLS CUI [1,1])
C0456532 (UMLS CUI [1,2])
TNM Stage at initial diagnosis, regional lymph nodes
Code List
TNM Stage at initial diagnosis, regional lymph nodes
CL Item
NOI+ (N0i+)
CL Item
N1 (N1)
CL Item
N1MI (N1mi)
CL Item
N2 (N2)
CL Item
N2A (N2A)
CL Item
N2B (N2B)
CL Item
N2C (N2C)
CL Item
N3 (N3)
CL Item
NX (NX)
CL Item
N0 (N0)
Item
TNM Stage at initial diagnosis, distant metastasis
text
C4071762 (UMLS CUI [1,1])
C0456533 (UMLS CUI [1,2])
TNM Stage at initial diagnosis, distant metastasis
Code List
TNM Stage at initial diagnosis, distant metastasis
CL Item
M0 (M0)
CL Item
M1 (M1)
CL Item
MX (MX)
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
Infiltrating ductal NOS (12)
CL Item
Infiltrating lobular carcinoma (36)
CL Item
Tubular adenocarcinoma (9)
CL Item
Unknown (U)
CL Item
Other, Specify (OT)
Histology at initial diagnosis, other
Item
Other histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Histological Grade at Initial Diagnosis
integer
C0677930 (UMLS CUI [1,1])
C0919553 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
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
Moderately differentiated (2)
CL Item
Poorly differentiated (3)
CL Item
Undifferentiated (4)
Date of last progression
Item
Date of last progression
partialDate
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Date of Staging at Screening
Item
Date of Staging at Screening
partialDate
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Item
Stage at Screening
text
C1300072 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Stage at Screening
Code List
Stage at Screening
CL Item
0 (0)
CL Item
I (1)
CL Item
Ia (1A)
CL Item
1b (1B)
CL Item
1c (1C)
CL Item
II (2)
CL Item
IIa (2A)
CL Item
IIb (2B)
CL Item
IIc (2C)
CL Item
III (3)
CL Item
IIIa (3A)
CL Item
IIIb (3B)
CL Item
IIIc (3C)
CL Item
IV (4)
CL Item
IVa (4A)
CL Item
IVb (4B)
CL Item
IVc (4C)
Item
Extent of Disease at Screening
text
C0220908 (UMLS CUI [1,1])
C0449279 (UMLS CUI [1,2])
Extend of Disease at Screening
Code List
Extent of Disease at Screening
CL Item
Limited (1)
CL Item
Extensive (2)
CL Item
Local Unresectable (3)
CL Item
Metastatic (4)
CL Item
Unknown (U)
Item
Primary tumor In Situ
text
C0677930 (UMLS CUI [1,1])
C0007099 (UMLS CUI [1,2])
Primary tumor In Situ
Code List
Primary tumor In Situ
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item Group
C1512413 (UMLS CUI-1)
Date of ErbB2 Biopsy
Item
Date of ErbB2 Biopsy
partialDate
C0005558 (UMLS CUI [1,1])
C1512413 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Disease Setting for the Biopsy
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Disease Setting for the Biopsy
Code List
Disease Setting for the Biopsy
CL Item
Initial Diagnosis (1)
CL Item
At Recurrence/Relapse (2)
Item
ErbB2 (Her2/neu) Status ImmunoHisto-Chemistry (IHC)
text
C1512413 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
ErbB2 (Her2neu) Status IHC
Code List
ErbB2 (Her2/neu) Status ImmunoHisto-Chemistry (IHC)
CL Item
0 (0)
CL Item
1+ (1)
CL Item
2+ (2)
CL Item
3+ (3)
CL Item
Unknown (U)
Item
Fluorescence in Situ Hybridization (FISH)
text
C0162789 (UMLS CUI [1])
Fluorescence in Situ Hybridization (FISH)
Code List
Fluorescence in Situ Hybridization (FISH)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Borderline (3)
CL Item
Unknwon (U)
Item
Chromogenic in Situ Hybridization (CISH)
text
C1516514 (UMLS CUI [1])
Chromogenic in Situ Hybridization (CISH)
Code List
Chromogenic in Situ Hybridization (CISH)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Borderline (3)
CL Item
Unknown (U)
Item Group
Disease characteristics
C0599878 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
Item
Primary tumor at initial diagnosis
text
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
Primary tumor type at initial diagnosis
Code List
Primary tumor at initial diagnosis
CL Item
Anus (1)
CL Item
BIle Duct (3)
CL Item
Bladder (2)
CL Item
Bone (4)
CL Item
Brain (5)
CL Item
Cervix (7)
CL Item
CNS (8)
CL Item
Colon/Rectum (9)
CL Item
Endometrium/Uterus (10)
CL Item
Eosophagus/Oesophagus (11)
CL Item
Fallopian Tube (42)
CL Item
Gall Bladder (12)
CL Item
Gastric (35)
CL Item
Gastric Cardia (45)
CL Item
Gastroesophageal Junction (46)
CL Item
Head and Neck (13)
CL Item
Kaposi's Sarcoma (15)
CL Item
Kidney (16)
CL Item
Liver (17)
CL Item
Melanoma (19)
CL Item
Mesothelioma (20)
CL Item
Mouth (21)
CL Item
Neuroblastoma (26)
CL Item
Neuroendocrine (47)
CL Item
Non-Small Cell Lung (25)
CL Item
Ovary (27)
CL Item
Pancreas (28)
CL Item
Primary Peritoneal (43)
CL Item
Prostate (29)
CL Item
Renal Cell (44)
CL Item
Retinoblastoma (30)
CL Item
Salivary Glands (31)
CL Item
Small Cell Lung (33)
CL Item
Small Intestine (32)
CL Item
Soft Tissue Sarcoma (34)
CL Item
Testicle (36)
CL Item
Thyroid (37)
CL Item
Vagina (38)
CL Item
Vulva (39)
CL Item
Wilm's Tumour (40)
CL Item
Unknown (U)
CL Item
Other, Specify (OT)
Primary tumor type at initial diagnosis, other
Item
Other Primary tumor at initial diagnosis
text
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Date of initial diagnosis
Item
Date of initial diagnosis
partialDate
C2316983 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Item
TNM Staging at initial diagnosis, primary tumor
text
C4071762 (UMLS CUI [1,1])
C0475455 (UMLS CUI [1,2])
TNM Stage at initial diagnosis, primary tumor
Code List
TNM Staging at initial diagnosis, primary tumor
CL Item
T0 (T0)
CL Item
T1 (T1)
CL Item
T1A (T1a)
CL Item
T1B (T1b)
CL Item
T1C (T1c)
CL Item
T2 (T2)
CL Item
T2A (T2a)
CL Item
T2B (T2b)
CL Item
T2C (T2c)
CL Item
T3 (T3)
CL Item
T3A (T3a)
CL Item
T3B (T3b)
CL Item
T3C (T3c)
CL Item
T4 (T4)
CL Item
TIS (TIS)
CL Item
TX (TX)
Item
TNM Stage at initial diagnosis, regional lymph nodes
text
C4071762 (UMLS CUI [1,1])
C0456532 (UMLS CUI [1,2])
TNM Stage at initial diagnosis, regional lymph nodes
Code List
TNM Stage at initial diagnosis, regional lymph nodes
CL Item
NOI+ (N0i+)
CL Item
N1 (N1)
CL Item
N1MI (N1mi)
CL Item
N2 (N2)
CL Item
N2A (N2A)
CL Item
N2B (N2B)
CL Item
N2C (N2C)
CL Item
N3 (N3)
CL Item
NX (NX)
CL Item
N0 (N0)
Item
TNM Stage at initial diagnosis, distant metastasis
text
C4071762 (UMLS CUI [1,1])
C0456533 (UMLS CUI [1,2])
TNM Stage at initial diagnosis, distant metastasis
Code List
TNM Stage at initial diagnosis, distant metastasis
CL Item
M0 (M0)
CL Item
M1 (M1)
CL Item
MX (MX)
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
Acral lentiginous melanoma (21)
CL Item
Adenocarcinoma (1)
CL Item
Adenosquamous carcinoma (41)
CL Item
Anaplastic astrocytoma (42)
CL Item
Anaplastic oligodendroglioma (43)
CL Item
Atypical ductal hyperplasia (ADH) (32)
CL Item
Balloon cell melanoma (25)
CL Item
Blue nevus, malignant (26)
CL Item
Bronchioalveolar (6)
CL Item
Carcinoid tumor (51)
CL Item
Carcinosarcoma (55)
CL Item
Clear cell (13)
CL Item
Desmoplastic melanoma (22)
CL Item
Ductal carcinoma in situ (DCIS) (34)
CL Item
Epithelial cell (29)
CL Item
Epithelioid cell melanoma (23)
CL Item
Glioblastoma multiforme (45)
CL Item
Gliosarcoma (46)
CL Item
Hepatocellular Carcinoma (47)
CL Item
High Grade Transitional Cell (53)
CL Item
Infiltrating carcinoma (35)
CL Item
Infiltrating ductal NOS (12)
CL Item
Infiltrating lobular carcinoma (36)
CL Item
Inflammatory breast carcinoma (37)
CL Item
Insitu breast carcinoma (40)
CL Item
Invasive breast carcinoma (39)
CL Item
Large cell carcinoma (28)
CL Item
Lentigo maligna melanoma (20)
CL Item
Lobular carcinoma in situ (LCIS) (33)
CL Item
Lobular invasive (8)
CL Item
Low Grade Transitional Cell  (52)
CL Item
Malignant endometrioid tumours (4)
CL Item
Malignant melanoma in giant pigmented nevus (27)
CL Item
Malignant melanoma NOS (17)
CL Item
Malignant mucinous tumours (3)
CL Item
Malignant serous tumours (2)
CL Item
Medullary (10)
CL Item
Melanoma in situ (16)
CL Item
Metaplastic breast carcinoma (38)
CL Item
Mixed anaplastic oligoastrocytoma (44)
CL Item
Mixed epithelial cell  (14)
CL Item
Mucinous adenocarcinoma (50)
CL Item
Nodular melanoma (19)
CL Item
Papillary adenocarcinoma (11)
CL Item
Papillary Serous (54)
CL Item
Poorly differentiated adenocarcinoma (48)
CL Item
Predominantly clear cell (31)
CL Item
Sarcoma (30)
CL Item
Signet-ring cell carcinoma (49)
CL Item
Spindle cell melanoma (24)
CL Item
Squamous cell carcinoma (7)
CL Item
Superficial spreading melanoma (18)
CL Item
Undifferentiated adenocarcinoma (15)
CL Item
Undifferentiated carcinoma (5)
CL Item
Unknown (U)
CL Item
Other, Specify (OT)
Histology at initial diagnosis, other
Item
Other histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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
Moderately differentiated (2)
CL Item
Poorly differentiated (3)
CL Item
Undifferentiated (4)
Date of last progression
Item
Date of last progression
partialDate
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Date of Staging at Screening
Item
Date of Staging at Screening
partialDate
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Item
Stage at Screening
text
C1300072 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Stage at Screening
Code List
Stage at Screening
CL Item
0 (0)
CL Item
I (1)
CL Item
Ia (1A)
CL Item
1b (1B)
CL Item
1c (1C)
CL Item
II (2)
CL Item
IIa (2A)
CL Item
IIb (2B)
CL Item
IIc (2C)
CL Item
III (3)
CL Item
IIIa (3A)
CL Item
IIIb (3B)
CL Item
IIIc (3C)
CL Item
IV (4)
CL Item
IVa (4A)
CL Item
IVb (4B)
CL Item
IVc (4C)
Item
Extent of Disease at Screening
text
C0220908 (UMLS CUI [1,1])
C0449279 (UMLS CUI [1,2])
Extend of Disease at Screening
Code List
Extent of Disease at Screening
CL Item
Limited (1)
CL Item
Extensive (2)
CL Item
Local Unresectable (3)
CL Item
Metastatic (4)
CL Item
Unknown (U)
Item
Primary tumor In Situ
text
C0677930 (UMLS CUI [1,1])
C0007099 (UMLS CUI [1,2])
Primary tumor In Situ
Code List
Primary tumor In Situ
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item Group
Metastatic disease characteristics
C0599878 (UMLS CUI-1)
C0027627 (UMLS CUI-2)
Item
Metastatic Disease at Screening
text
C0027627 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Metastatic Disease at Screening
Code List
Metastatic Disease at Screening
CL Item
Yes, Complete Date Metastatic Disease was First Diagnosed (Y)
CL Item
No (N)
initial Neoplasm Metastatis, Date
Item
Metastatic Disease at Screening, Date
partialDate
C0027627 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0449976 (UMLS CUI [1,3])
Item
Adrenals
text
C0001625 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Adrenals
Code List
Adrenals
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Bladder
text
C0005682 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Bladder
Code List
Bladder
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Bone
text
C0262950 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Bone
Code List
Bone
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Bone Marrow
text
C0005953 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Bone Marrow
Code List
Bone Marrow
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Breast
text
C0006141 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Breast
Code List
Breast
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Chest Wall
text
C0205076 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Chest Wall
Code List
Chest Wall
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
CNS
text
C3714787 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Central nervous system
Code List
CNS
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Kidney
text
C0022646 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Kidney
Code List
Kidney
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Liver
text
C0023884 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Liver
Code List
Liver
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Lung
text
C0024109 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Lung
Code List
Lung
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Lymph nodes
text
C0024204 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Lymph nodes
Code List
Lymph nodes
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Ovary
text
C0029939 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Ovary
Code List
Ovary
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Peritoneum
text
C0031153 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Peritoneum
Code List
Peritoneum
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Pleura
text
C0032225 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Pleura
Code List
Pleura
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Skin
text
C1123023 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Skin
Code List
Skin
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Item
Other
text
C0205394 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Other
Code List
Other
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Other to specify
Item
Other to specify
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
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