ID
41450
Description
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases
Keywords
Versions (1)
- 10/13/20 10/13/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 13, 2020
DOI
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License
Creative Commons BY 4.0
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Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073
Day 1 Predose
- StudyEvent: ODM
Description
Neurological Examination Worksheet
Alias
- UMLS CUI-1
- C0027853
Description
Level of consciousness
Data type
text
Alias
- UMLS CUI [1]
- C0234425
Description
Neurologic Symptoms
Data type
text
Alias
- UMLS CUI [1]
- C0235031
Description
Neurologic Symptoms, Other
Data type
text
Alias
- UMLS CUI [1,1]
- C0235031
- UMLS CUI [1,2]
- C0205394
Description
Neurologic Symptoms, Other, Adverse Event Grade Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0235031
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2985911
Description
Cranial Nerves
Data type
text
Alias
- UMLS CUI [1]
- C0010268
Description
Cranial Nerves, Abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1704258
Description
Dysphasia; Aphasia
Data type
text
Alias
- UMLS CUI [1]
- C0973461
- UMLS CUI [2]
- C0003537
Description
Muscle Strength, Right upper extremity
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230329
Description
Muscle Strength, Right upper extremity, Abnormality, Muscle
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230329
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0026845
Description
Muscle Strength, Right upper extremity, Abnormality, Grade
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230329
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0441800
Description
Muscle Strength, Left upper extremity
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230330
Description
Muscle Strength, Left upper extremity, Abnormality, Muscle
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230330
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0026845
Description
Muscle Strength, Left upper extremity, Abnormality, Grade
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230330
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0441800
Description
Muscle Strength, Right lower extremity
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230415
Description
Muscle Strength, Right lower extremity, Abnormality, Muscle
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230415
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0026845
Description
Muscle Strength, Right lower extremity, Abnormality, Grade
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230415
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0441800
Description
Muscle Strength, Left lower extremity
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230416
Description
Muscle Strength, Left lower extremity, Abnormality, Muscle
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230416
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0026845
Description
Muscle Strength, Left lower extremity, Abnormality, Grade
Data type
text
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C0230416
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0441800
Description
Esthesia
Data type
text
Alias
- UMLS CUI [1]
- C0036658
Description
Esthesia, Abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C0036658
- UMLS CUI [1,2]
- C1704258
Description
Ataxia, Right upper extremity
Data type
text
Alias
- UMLS CUI [1,1]
- C0004134
- UMLS CUI [1,2]
- C0230329
Description
Ataxia, Left upper extremity
Data type
text
Alias
- UMLS CUI [1,1]
- C0004134
- UMLS CUI [1,2]
- C0230330
Description
Gait Ataxia
Data type
text
Alias
- UMLS CUI [1]
- C0751837
Description
Ataxia, Ability to balance
Data type
text
Alias
- UMLS CUI [1,1]
- C0004134
- UMLS CUI [1,2]
- C0560184
Description
Summary of Tumor-Related Neurological Signs and Symptoms
Alias
- UMLS CUI-1
- C0235031
- UMLS CUI-2
- C0332281
- UMLS CUI-3
- C0027651
Description
Neurologic Symptoms, Associated with, Neoplasms
Data type
text
Alias
- UMLS CUI [1,1]
- C0235031
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0027651
Description
Neurologic Symptoms, Associated with, Neoplasms
Data type
text
Alias
- UMLS CUI [1,1]
- C0235031
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0027651
Description
Neurologic Symptoms, Associated with, Neoplasms, Withdraw
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0235031
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0027651
- UMLS CUI [1,4]
- C2349954
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Vital signs, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body Surface Area
Data type
float
Measurement units
- m2
Alias
- UMLS CUI [1]
- C0005902
Description
Systolic Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Body Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Randomization Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Description
Randomization, Possible
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0332149
Description
Randomization, Numbers
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
Randomization, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Description
Regimen
Alias
- UMLS CUI-1
- C1276413
Similar models
Day 1 Predose
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0003537 (UMLS CUI [2])
C0230329 (UMLS CUI [1,2])
C0230329 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0026845 (UMLS CUI [1,4])
C0230329 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0230330 (UMLS CUI [1,2])
C0230330 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0026845 (UMLS CUI [1,4])
C0230330 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0230415 (UMLS CUI [1,2])
C0230415 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0026845 (UMLS CUI [1,4])
C0230415 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0230416 (UMLS CUI [1,2])
C0230416 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0026845 (UMLS CUI [1,4])
C0230416 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0230329 (UMLS CUI [1,2])
C0230330 (UMLS CUI [1,2])
C0560184 (UMLS CUI [1,2])
C0332281 (UMLS CUI-2)
C0027651 (UMLS CUI-3)
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])