ID

22127

Description

Study part: Study termination physical examination. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Keywords

Versions (1)
  1. 5/20/17 5/20/17 -
Copyright Holder

Roche

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May 20, 2017

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Creative Commons BY-NC 3.0
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STUDY TERMINATION PHYSICAL EXAMINATION Roche H0650g Breast Cancer

English

STUDY TERMINATION PHYSICAL EXAMINATION

1 forms  
PHYSICAL EXAMINATION
Description

PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0031809
PATIENT INT.
Description

Patient initial

Data type

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Description

Patient id

Data type

integer

Alias
UMLS CUI [1]
C2348585
DATE OF EXAMINATION
Description

DATE OF EXAMINATION

Data type

date

Alias
UMLS CUI [1]
C2826643
WEIGHT
Description

WEIGHT

Data type

float

Measurement units
  • lb
Alias
UMLS CUI [1]
C0005910
lb
WEIGHT
Description

WEIGHT

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
TEMPERATURE
Description

TEMPERATURE

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
TEMPERATURE
Description

TEMPERATURE

Data type

float

Measurement units
  • °F
Alias
UMLS CUI [1]
C0039476
°F
SYSTOLIC BLOOD PRESSURE
Description

SYSTOLIC BLOOD PRESSURE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
DIASTOLIC BLOOD PRESSURE
Description

Diastolic blood pressure

Data type

integer

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

Heart rate

Data type

integer

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

respiratory rate

Data type

integer

Measurement units
  • resp/min
Alias
UMLS CUI [1]
C0231832
resp/min
1. HEENT
Description

HEAD.EARS. EYES. NOSE. THROAT

Data type

text

Alias
UMLS CUI [1]
C1512338
1. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
1. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
2. NECK
Description

NECK

Data type

text

Alias
UMLS CUI [1]
C0027530
2. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
2. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
3. BREASTS
Description

BREASTS

Data type

text

Alias
UMLS CUI [1]
C0199850
3. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
3. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
4. CHEST
Description

CHEST

Data type

text

Alias
UMLS CUI [1]
C0817096
4. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
4. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
5. LYMPH NODES
Description

LYMPH NODES

Data type

text

Alias
UMLS CUI [1]
C0024204
5. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
5. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
6. HEART
Description

HEART

Data type

text

Alias
UMLS CUI [1]
C0018787
6. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
6. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
7. ABDOMEN
Description

ABDOMEN

Data type

text

Alias
UMLS CUI [1]
C0000726
7. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
7. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
8. PELVIC
Description

PELVIC

Data type

text

Alias
UMLS CUI [1]
C0030797
8. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
8. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
9. RECTAL
Description

RECTAL

Data type

text

Alias
UMLS CUI [1]
C0199900
9. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
9. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
10. EXTREMITIES
Description

EXTREMITIES

Data type

text

Alias
UMLS CUI [1]
C0436150
10. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
10. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
11. NEUROLOGICAL
Description

NEUROLOGICAL

Data type

text

Alias
UMLS CUI [1]
C0027853
11. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
11. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
12. SKIN
Description

SKIN

Data type

text

Alias
UMLS CUI [1]
C1123023
12. IF ABNORMAL, DESCRIBE:
Description

description

Data type

text

Alias
UMLS CUI [1]
C0678257
12. FINDING IS AN AE?
Description

finding adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
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Similar models

STUDY TERMINATION PHYSICAL EXAMINATION

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PHYSICAL EXAMINATION
C0031809 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
DATE OF EXAMINATION
Item
DATE OF EXAMINATION
date
C2826643 (UMLS CUI [1])
WEIGHT
Item
WEIGHT
float
C0005910 (UMLS CUI [1])
WEIGHT
Item
WEIGHT
float
C0005910 (UMLS CUI [1])
TEMPERATURE
Item
TEMPERATURE
float
C0039476 (UMLS CUI [1])
TEMPERATURE
Item
TEMPERATURE
float
C0039476 (UMLS CUI [1])
SYSTOLIC BLOOD PRESSURE
Item
SYSTOLIC BLOOD PRESSURE
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
DIASTOLIC BLOOD PRESSURE
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
HR
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
RR
integer
C0231832 (UMLS CUI [1])
Item
1. HEENT
text
C1512338 (UMLS CUI [1])
HEENT
Code List
1. HEENT
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
1. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
1. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
2. NECK
text
C0027530 (UMLS CUI [1])
HEENT
Code List
2. NECK
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
2. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
2. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
3. BREASTS
text
C0199850 (UMLS CUI [1])
HEENT
Code List
3. BREASTS
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
3. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
3. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
4. CHEST
text
C0817096 (UMLS CUI [1])
HEENT
Code List
4. CHEST
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
4. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
4. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
5. LYMPH NODES
text
C0024204 (UMLS CUI [1])
HEENT
Code List
5. LYMPH NODES
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
5. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
5. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
6. HEART
text
C0018787 (UMLS CUI [1])
HEENT
Code List
6. HEART
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
6. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
6. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
7. ABDOMEN
text
C0000726 (UMLS CUI [1])
HEENT
Code List
7. ABDOMEN
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
7. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
7. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
8. PELVIC
text
C0030797 (UMLS CUI [1])
HEENT
Code List
8. PELVIC
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
8. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
8. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
9. RECTAL
text
C0199900 (UMLS CUI [1])
HEENT
Code List
9. RECTAL
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
9. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
9. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
10. EXTREMITIES
text
C0436150 (UMLS CUI [1])
HEENT
Code List
10. EXTREMITIES
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
10. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
10. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
11. NEUROLOGICAL
text
C0027853 (UMLS CUI [1])
HEENT
Code List
11. NEUROLOGICAL
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
11. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
11. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
12. SKIN
text
C1123023 (UMLS CUI [1])
HEENT
Code List
12. SKIN
CL Item
NORMAL  (1)
CL Item
ABNORMAL  (2)
CL Item
NOT DONE (3)
description
Item
12. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
12. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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