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

  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

  1. StudyEvent: ODM
    1. Day 1 Predose
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date of visit; Assessment Date

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Neurological Examination Worksheet
Description

Neurological Examination Worksheet

Alias
UMLS CUI-1
C0027853
Level of consciousness
Description

Level of consciousness

Data type

text

Alias
UMLS CUI [1]
C0234425
Neurological symptoms
Description

Neurologic Symptoms

Data type

text

Alias
UMLS CUI [1]
C0235031
Other Neurological Symptoms - Specify neurological symptom
Description

Neurologic Symptoms, Other

Data type

text

Alias
UMLS CUI [1,1]
C0235031
UMLS CUI [1,2]
C0205394
Other Neurological Symptoms - CTCAE Grade
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
Cranial Nerves and Language - Cranial nerves II-XII
Description

Cranial Nerves

Data type

text

Alias
UMLS CUI [1]
C0010268
Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
Description

Cranial Nerves, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0010268
UMLS CUI [1,2]
C1704258
Cranial Nerves and Language - Language - Dysphasia or aphasia
Description

Dysphasia; Aphasia

Data type

text

Alias
UMLS CUI [1]
C0973461
UMLS CUI [2]
C0003537
Strength - Right upper extremity
Description

Muscle Strength, Right upper extremity

Data type

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230329
Strength - Right upper extremity - If abnormal, specify the muscle group
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
Strength - Right upper extremity - Grade
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
Strength - Left upper extremity
Description

Muscle Strength, Left upper extremity

Data type

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230330
Strength - Left upper extremity - If abnormal, specify the muscle group
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
Strength - Left upper extremity - Grade
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
Strength - Right lower extremity
Description

Muscle Strength, Right lower extremity

Data type

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230415
Strength - Right lower extremity - If abnormal, specify the muscle group
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
Strength - Right lower extremity - Grade
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
Strength - Left lower extremity
Description

Muscle Strength, Left lower extremity

Data type

text

Alias
UMLS CUI [1,1]
C0517349
UMLS CUI [1,2]
C0230416
Strength - Left lower extremity - If abnormal, specify the muscle group
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
Strength - Left lower extremity - Grade
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
Sensation
Description

Esthesia

Data type

text

Alias
UMLS CUI [1]
C0036658
Sensation - If abnormal, specify location/distribution
Description

Esthesia, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0036658
UMLS CUI [1,2]
C1704258
Ataxia - Right upper extremity (finger to nose testing)
Description

Ataxia, Right upper extremity

Data type

text

Alias
UMLS CUI [1,1]
C0004134
UMLS CUI [1,2]
C0230329
Ataxia - Left upper extremity (finger to nose testing)
Description

Ataxia, Left upper extremity

Data type

text

Alias
UMLS CUI [1,1]
C0004134
UMLS CUI [1,2]
C0230330
Ataxia - Gait
Description

Gait Ataxia

Data type

text

Alias
UMLS CUI [1]
C0751837
Ataxia - Balance (Romberg)
Description

Ataxia, Ability to balance

Data type

text

Alias
UMLS CUI [1,1]
C0004134
UMLS CUI [1,2]
C0560184
Summary of Tumor-Related Neurological Signs and Symptoms
Description

Summary of Tumor-Related Neurological Signs and Symptoms

Alias
UMLS CUI-1
C0235031
UMLS CUI-2
C0332281
UMLS CUI-3
C0027651
Overall summary of tumor-related NSS for this visit
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
If checked, please specify NSS
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
Is subject being withdrawn from study due to progessive tumor-related symptomatology?
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
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date
Description

Vital signs, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Description

Body Surface Area

Data type

float

Measurement units
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Blood pressure - Systolic
Description

Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure - Diastolic
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Randomization Number
Description

Randomization Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Description

Randomization, Possible

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0332149
Yes, provide Randomisation number
Description

Randomization, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Yes, provide Date of randomization
Description

Randomization, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Regimen
Description

Regimen

Alias
UMLS CUI-1
C1276413
Assigned Regimen
Description

Therapeutic regimen

Data type

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C1276413

Similar models

Day 1 Predose

  1. StudyEvent: ODM
    1. Day 1 Predose
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Neurological Examination Worksheet
C0027853 (UMLS CUI-1)
Item
Level of consciousness
text
C0234425 (UMLS CUI [1])
Code List
Level of consciousness
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)
Item
Neurological symptoms
text
C0235031 (UMLS CUI [1])
Code List
Neurological symptoms
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])
Item
Other Neurological Symptoms - CTCAE Grade
text
C0235031 (UMLS CUI [1,1])
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])
Code List
Cranial Nerves and Language - Cranial nerves II-XII
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])
Code List
Cranial Nerves and Language - If abnormal, specify which nerve(s) affected
Item
Cranial Nerves and Language - Language - Dysphasia or aphasia
text
C0973461 (UMLS CUI [1])
C0003537 (UMLS CUI [2])
Code List
Cranial Nerves and Language - Language - Dysphasia or aphasia
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])
Code List
Strength - Right upper extremity
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])
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])
Code List
Strength - Right upper extremity - Grade
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])
Code List
Strength - Left upper extremity
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])
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])
Code List
Strength - Left upper extremity - Grade
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])
Code List
Strength - Right lower extremity
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])
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])
Code List
Strength - Right lower extremity - Grade
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])
Code List
Strength - Left lower extremity
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])
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])
Code List
Strength - Left lower extremity - Grade
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
Sensation
text
C0036658 (UMLS CUI [1])
Code List
Sensation
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])
Code List
Sensation - If abnormal, specify location/distribution
Item
Ataxia - Right upper extremity (finger to nose testing)
text
C0004134 (UMLS CUI [1,1])
C0230329 (UMLS CUI [1,2])
Code List
Ataxia - Right upper extremity (finger to nose testing)
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])
Code List
Ataxia - Left upper extremity (finger to nose testing)
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 - Gait
text
C0751837 (UMLS CUI [1])
Code List
Ataxia - Gait
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])
Code List
Ataxia - Balance (Romberg)
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)
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])
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])
Code List
If checked, please specify NSS
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])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital signs, Date in time
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
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])
Item Group
Randomization Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomization, Possible
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Randomization, Numbers
Item
Yes, provide Randomisation number
integer
C0034656 (UMLS CUI [1,1])
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])
Item Group
Regimen
C1276413 (UMLS CUI-1)
Item
Assigned Regimen
text
C2348585 (UMLS CUI [1,1])
C1276413 (UMLS CUI [1,2])
Code List
Assigned Regimen
CL Item
Lapatinib plus Topotecan Arm  (1)
CL Item
Lapatinib plus Capecitabine Arm (2)

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