ID

22127

Beskrivning

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"

Nyckelord

Versioner (1)
  1. 2017-05-20 2017-05-20 -
Rättsinnehavare

Roche

Uppladdad den

20 maj 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

STUDY TERMINATION PHYSICAL EXAMINATION Roche H0650g Breast Cancer

Engelsk

STUDY TERMINATION PHYSICAL EXAMINATION

1 Formulär  
PHYSICAL EXAMINATION
Beskrivning

PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0031809
PATIENT INT.
Beskrivning

Patient initial

Datatyp

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Beskrivning

Patient id

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
DATE OF EXAMINATION
Beskrivning

DATE OF EXAMINATION

Datatyp

date

Alias
UMLS CUI [1]
C2826643
WEIGHT
Beskrivning

WEIGHT

Datatyp

float

Måttenheter
  • lb
Alias
UMLS CUI [1]
C0005910
lb
WEIGHT
Beskrivning

WEIGHT

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
TEMPERATURE
Beskrivning

TEMPERATURE

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0039476
°C
TEMPERATURE
Beskrivning

TEMPERATURE

Datatyp

float

Måttenheter
  • °F
Alias
UMLS CUI [1]
C0039476
°F
SYSTOLIC BLOOD PRESSURE
Beskrivning

SYSTOLIC BLOOD PRESSURE

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
DIASTOLIC BLOOD PRESSURE
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
HR
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
RR
Beskrivning

respiratory rate

Datatyp

integer

Måttenheter
  • resp/min
Alias
UMLS CUI [1]
C0231832
resp/min
1. HEENT
Beskrivning

HEAD.EARS. EYES. NOSE. THROAT

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

NECK

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

BREASTS

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

CHEST

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

LYMPH NODES

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

HEART

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

ABDOMEN

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

PELVIC

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

RECTAL

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

EXTREMITIES

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

NEUROLOGICAL

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

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

SKIN

Datatyp

text

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

description

Datatyp

text

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

finding adverse event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0877248
Tillbaka till toppen

Similar models

STUDY TERMINATION PHYSICAL EXAMINATION

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial