ID

40267

Beschreibung

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 prior Anti-Cancer procedures. It has to be filled in for screening.

Link

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

Stichworte

Versionen (2)
  1. 26.03.20 26.03.20 - Christian Arras
  2. 26.03.20 26.03.20 - Christian Arras
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

26. März 2020

DOI

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Lizenz

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

Englisch

Prior Anti-Cancer procedures

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biological Therapy
Beschreibung

Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biological Therapy

Alias
UMLS CUI-1
C0920425
UMLS CUI-2
C1514463
UMLS CUI-3
C0392920
UMLS CUI-4
C0279025
UMLS CUI-5
C1531518
UMLS CUI-6
C0021083
Has the subject taken any prior cancer related therapy?
Beschreibung

If Yes, specify below

Datentyp

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
Sequence number
Beschreibung

hidden/not required

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Drug name
Beschreibung

Trade name preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Modified reported term
Beschreibung

hidden/not required,

Datentyp

text

Alias
UMLS CUI [1]
C2826923
GSK drug synonym
Beschreibung

hidden/not required

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Beschreibung

hidden/not required

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Beschreibung

hidden/not required

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Regime Sequence
Beschreibung

Treatment protocol, number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0237753
Therapy type
Beschreibung

Therapy type, cancer treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0920425
Number of Cycles/Doses
Beschreibung

Number of Cycles, Dosage count

Datentyp

integer

Alias
UMLS CUI [1]
C2045831
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0750480
Units
Beschreibung

Units

Datentyp

integer

Alias
UMLS CUI [1]
C1519795
Primary Intent
Beschreibung

Primary Intent, cancer treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0920425
Start Date
Beschreibung

Start Date

Datentyp

partialDate

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

End Date

Datentyp

partialDate

Alias
UMLS CUI [1]
C0806020
Cancer Therapy Treatment
Beschreibung

hidden/not required

Datentyp

text

Alias
UMLS CUI [1]
C0920425
Prior Anti-Cancer Therapy: Radiotherapy
Beschreibung

Prior Anti-Cancer Therapy: Radiotherapy

Alias
UMLS CUI-1
C0279134
UMLS CUI-2
C0920425
Has the subject received any prior radiotherapy
Beschreibung

If yes, please specify below:

Datentyp

text

Alias
UMLS CUI [1]
C0279134
Sequence number
Beschreibung

hidden/not required

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Site
Beschreibung

irradiation site

Datentyp

text

Alias
UMLS CUI [1]
C2169202
Primary Intent
Beschreibung

Primary Intent, cancer treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0920425
Start Date
Beschreibung

Start Date

Datentyp

partialDate

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

End Date

Datentyp

partialDate

Alias
UMLS CUI [1]
C0806020
Cancer Therapy Treatment
Beschreibung

This will be a hidden Item populated by a rule

Datentyp

text

Alias
UMLS CUI [1]
C0920425
Prior anti-cancer medical/surgical procedures
Beschreibung

Prior anti-cancer medical/surgical procedures

Alias
UMLS CUI-1
C1948041
UMLS CUI-2
C0920425
UMLS CUI-3
C1514463
Has the subject had any cancer related Medical/Surgical Procedures?
Beschreibung

If Yes, please specify below:

Datentyp

text

Alias
UMLS CUI [1,1]
C2826292
UMLS CUI [1,2]
C1948041
Sequence number
Beschreibung

hidden/not required

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Specific procedure
Beschreibung

Therapeutic Procedure

Datentyp

text

Alias
UMLS CUI [1]
C0087111
Date of Procedure
Beschreibung

Time is optional

Datentyp

partialDatetime

Alias
UMLS CUI [1]
C2584899
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Ähnliche Modelle

Prior Anti-Cancer procedures

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biological Therapy
C0920425 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0392920 (UMLS CUI-3)
C0279025 (UMLS CUI-4)
C1531518 (UMLS CUI-5)
C0021083 (UMLS CUI-6)
Item
Has the subject taken any prior cancer related therapy?
text
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Prior anti-cancer therapy
Code List
Has the subject taken any prior cancer related therapy?
CL Item
Yes (Y)
CL Item
No (N)
Sequence number
Item
Sequence number
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826923 (UMLS CUI [1])
GSK drug synonym
Item
GSK drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Treatment protocol, number
Item
Regime Sequence
integer
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Therapy type
text
C0087111 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Therapy type
Code List
Therapy type
CL Item
Biologic Therapy (antibodies, cytokines) (B)
CL Item
Chemotherapy (cytotoxics, non-cytotoxics) (C)
CL Item
Hormonal Therapy (H)
CL Item
Immunotherapy (I)
Number of Cycles, Dosage count
Item
Number of Cycles/Doses
integer
C2045831 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
Item
Units
integer
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
Cycles (1)
CL Item
Doses (2)
Item
Primary Intent
text
C1283828 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Primary Intent
Code List
Primary Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or Metastatic (3)
CL Item
Palliative (7)
CL Item
Curative (9)
CL Item
Other (OT)
Start Date
Item
Start Date
partialDate
C0808070 (UMLS CUI [1])
End Date
Item
Stop Date
partialDate
C0806020 (UMLS CUI [1])
Item
Cancer Therapy Treatment
text
C0920425 (UMLS CUI [1])
Cancer Treatment
Code List
Cancer Therapy Treatment
CL Item
Prior Treatment (1)
Item Group
Prior Anti-Cancer Therapy: Radiotherapy
C0279134 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
Item
Has the subject received any prior radiotherapy
text
C0279134 (UMLS CUI [1])
prior radiation therapy
Code List
Has the subject received any prior radiotherapy
CL Item
Yes (Y)
CL Item
No (N)
Sequence number
Item
Sequence number
text
C2348184 (UMLS CUI [1])
irradiation site
Item
Site
text
C2169202 (UMLS CUI [1])
Item
Primary Intent
text
C1283828 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Primary Intent
Code List
Primary Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or Metastatic (3)
CL Item
Palliative (7)
CL Item
Curative (9)
CL Item
Other (OT)
Start Date
Item
Start Date
partialDate
C0808070 (UMLS CUI [1])
End Date
Item
Stop Date
partialDate
C0806020 (UMLS CUI [1])
Item
Cancer Therapy Treatment
text
C0920425 (UMLS CUI [1])
Cancer Treatment
Code List
Cancer Therapy Treatment
CL Item
Prior Treatment (1)
Item Group
Prior anti-cancer medical/surgical procedures
C1948041 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C1514463 (UMLS CUI-3)
Item
Has the subject had any cancer related Medical/Surgical Procedures?
text
C2826292 (UMLS CUI [1,1])
C1948041 (UMLS CUI [1,2])
cancer related Medical/Surgical Procedures
Code List
Has the subject had any cancer related Medical/Surgical Procedures?
CL Item
No (N)
CL Item
Yes (Y)
Sequence number
Item
Sequence number
text
C2348184 (UMLS CUI [1])
Therapeutic Procedure
Item
Specific procedure
text
C0087111 (UMLS CUI [1])
Date of procedure
Item
Date of Procedure
partialDatetime
C2584899 (UMLS CUI [1])
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