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ID
41450
Beschreibung
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
Stichworte
Versionen (1)
- 13.10.20 13.10.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
13. Oktober 2020
DOI
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Lizenz
Creative Commons BY 4.0
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Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073
Ähnliche Modelle
Day 1 Predose
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
C2985720 (UMLS CUI [2])
CL Item
Normal (1)
CL Item
Somnolence or sedation not interfering with function (2)
CL Item
Somnolence or sedation interfering with function, but not interfering with Activities of Daily Living (ADLs) (3)
CL Item
Obtundation or stupor; difficult to arouse; interfering with ADLs (4)
CL Item
Coma (5)
CL Item
No - Asymptomatic (1)
CL Item
Headache - Grade 1 (2)
CL Item
Headache - Grade 2 (3)
CL Item
Headache - Grade 3 (4)
CL Item
Headache - Grade 4 (5)
CL Item
Dizziness/lightheadedness - Grade 1 (6)
CL Item
Dizziness/lightheadedness - Grade 2 (7)
CL Item
Dizziness/lightheadedness - Grade 3 (8)
CL Item
Dizziness/lightheadedness - Grade 4 (9)
CL Item
Vertigo - Grade 1 (10)
CL Item
Vertigo - Grade 2 (11)
CL Item
Vertigo - Grade 3 (12)
CL Item
Vertigo - Grade 4 (13)
CL Item
Nausea/vomiting - Grade 1 (14)
CL Item
Nausea/vomiting - Grade 2 (15)
CL Item
Nausea/vomiting - Grade 3 (16)
CL Item
Nausea/vomiting - Grade 4 (17)
CL Item
Visual problems - Grade 1 (18)
CL Item
Visual problems - Grade 2 (19)
CL Item
Visual problems - Grade 3 (20)
CL Item
Visual problems - Grade 4 (21)
CL Item
Seizure - Grade 1 (22)
CL Item
Seizure - Grade 2 (23)
CL Item
Seizure - Grade 3 (24)
CL Item
Seizure - Grade 4 (25)
CL Item
Other, specify other neurological symptom(s) in the Other Neurological Symptoms section (26)
Neurologic Symptoms, Other
Item
Other Neurological Symptoms - Specify neurological symptom
text
C0235031 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item
Other Neurological Symptoms - CTCAE Grade
text
C0235031 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2985911 (UMLS CUI [1,3])
Code List
Other Neurological Symptoms - CTCAE Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Cranial Nerves and Language - Cranial nerves II-XII
text
C0010268 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Present, not interfering w/ADLs (2)
CL Item
Present, interfering w/ADLs (3)
CL Item
Life-threatening, disabling (4)
Item
Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
text
C0010268 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Item
Cranial Nerves and Language - Language - Dysphasia or aphasia
text
C0973461 (UMLS CUI [1])
C0003537 (UMLS CUI [2])
C0003537 (UMLS CUI [2])
CL Item
Absent (1)
CL Item
Awareness of receptive or expressive aphasia, not impairing ability to communicate (2)
CL Item
Receptive or expressive dysphasia, impairing ability to communicate (3)
CL Item
Inability to communicate (4)
Item
Strength - Right upper extremity
text
C0517349 (UMLS CUI [1,1])
C0230329 (UMLS CUI [1,2])
C0230329 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Strength - Right upper extremity - If abnormal, specify the muscle group
text
C0517349 (UMLS CUI [1,1])
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])
C0026845 (UMLS CUI [1,4])
Code List
Strength - Right upper extremity - If abnormal, specify the muscle group
Item
Strength - Right upper extremity - Grade
text
C0517349 (UMLS CUI [1,1])
C0230329 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0230329 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
CL Item
Grade 1 - asymptomatic with weakness on physical exam (1)
CL Item
Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
CL Item
Grade 3 - symptomatic and interfering with activities of daily living (3)
CL Item
Grade 4 - bedridden or disabling (4)
Item
Strength - Left upper extremity
text
C0517349 (UMLS CUI [1,1])
C0230330 (UMLS CUI [1,2])
C0230330 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Muscle Strength, Left upper extremity, Abnormality, Muscle
Item
Strength - Left upper extremity - If abnormal, specify the muscle group
text
C0517349 (UMLS CUI [1,1])
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])
C0026845 (UMLS CUI [1,4])
Item
Strength - Left upper extremity - Grade
text
C0517349 (UMLS CUI [1,1])
C0230330 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0230330 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
CL Item
Grade 1 - asymptomatic with weakness on physical exam (1)
CL Item
Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
CL Item
Grade 3 - symptomatic and interfering with activities of daily living (3)
CL Item
Grade 4 - bedridden or disabling (4)
Item
Strength - Right lower extremity
text
C0517349 (UMLS CUI [1,1])
C0230415 (UMLS CUI [1,2])
C0230415 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Muscle Strength, Right lower extremity, Abnormality, Muscle
Item
Strength - Right lower extremity - If abnormal, specify the muscle group
text
C0517349 (UMLS CUI [1,1])
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])
C0026845 (UMLS CUI [1,4])
Item
Strength - Right lower extremity - Grade
text
C0517349 (UMLS CUI [1,1])
C0230415 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0230415 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
CL Item
Grade 1 - asymptomatic with weakness on physical exam (1)
CL Item
Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
CL Item
Grade 3 - symptomatic and interfering with activities of daily living (3)
CL Item
Grade 4 - bedridden or disabling (4)
Item
Strength - Left lower extremity
text
C0517349 (UMLS CUI [1,1])
C0230416 (UMLS CUI [1,2])
C0230416 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Muscle Strength, Left lower extremity, Abnormality, Muscle
Item
Strength - Left lower extremity - If abnormal, specify the muscle group
text
C0517349 (UMLS CUI [1,1])
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])
C0026845 (UMLS CUI [1,4])
Item
Strength - Left lower extremity - Grade
text
C0517349 (UMLS CUI [1,1])
C0230416 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0230416 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
CL Item
Grade 1 - asymptomatic with weakness on physical exam (1)
CL Item
Grade 2 - symptomatic and interfering w/function, but not interfering with ADLs (2)
CL Item
Grade 3 - symptomatic and interfering with activities of daily living (3)
CL Item
Grade 4 - bedridden or disabling (4)
CL Item
Normal (1)
CL Item
Loss of deep tendon reflexes or paresthesia, but not interfering with function (2)
CL Item
Objective sensory loss or paresthesia interfering with function, but no interfering with ADLs (3)
CL Item
Sensory loss or paresthesia interfering with ADLs (4)
CL Item
Permanent sensory loss that interferes with function (5)
Item
Sensation - If abnormal, specify location/distribution
text
C0036658 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Item
Ataxia - Right upper extremity (finger to nose testing)
text
C0004134 (UMLS CUI [1,1])
C0230329 (UMLS CUI [1,2])
C0230329 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
CL Item
Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
CL Item
Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living (4)
CL Item
Abnormal - Grade 4 - bedridden or disabling (5)
Item
Ataxia - Left upper extremity (finger to nose testing)
text
C0004134 (UMLS CUI [1,1])
C0230330 (UMLS CUI [1,2])
C0230330 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
CL Item
Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
CL Item
Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living (4)
CL Item
Abnormal - Grade 4 - bedridden or disabling (5)
CL Item
Normal (1)
CL Item
Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
CL Item
Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
CL Item
Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living (4)
CL Item
Abnormal - Grade 4 - bedridden or disabling (5)
Item
Ataxia - Balance (Romberg)
text
C0004134 (UMLS CUI [1,1])
C0560184 (UMLS CUI [1,2])
C0560184 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Grade 1 - asymptomatic but abnormal on physical exam, and not interfering with function (2)
CL Item
Abnormal - Grade 2 - mild symptoms interfering with function, but not interfering with activities of daily living (3)
CL Item
Abnormal - Grade 3 - moderate symptoms interfering with activities of daily living (4)
CL Item
Abnormal - Grade 4 - bedridden or disabling (5)
Item Group
Summary of Tumor-Related Neurological Signs and Symptoms
C0235031 (UMLS CUI-1)
C0332281 (UMLS CUI-2)
C0027651 (UMLS CUI-3)
C0332281 (UMLS CUI-2)
C0027651 (UMLS CUI-3)
Item
Overall summary of tumor-related NSS for this visit
text
C0235031 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
Code List
Overall summary of tumor-related NSS for this visit
CL Item
Improvement. If checked, please specify NSS (1)
CL Item
Stable (2)
CL Item
Deterioration. If checked, please specify NSS (3)
Item
If checked, please specify NSS
text
C0235031 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
Neurologic Symptoms, Associated with, Neoplasms, Withdraw
Item
Is subject being withdrawn from study due to progessive tumor-related symptomatology?
boolean
C0235031 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,4])
Vital signs, Date in time
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body surface area
float
C0005902 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Randomization, Possible
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,2])
Randomization, Numbers
Item
Yes, provide Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Randomization, Date in time
Item
Yes, provide Date of randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Lapatinib plus Topotecan Arm (1)
CL Item
Lapatinib plus Capecitabine Arm (2)