ID

22206

Descripción

Study part: Serious adverse events. 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"

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Versiones (1)
  1. 23/5/17 23/5/17 -
Titular de derechos de autor

Roche

Subido en

23 de mayo de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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SERIOUS ADVERSE EVENTS Roche H0650g Breast Cancer

Inglés

SERIOUS ADVERSE EVENTS

1 formularios  
  1. StudyEvent: ODM
    1. SERIOUS ADVERSE EVENTS
SERIOUS ADVERSE EVENTS
Descripción

SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1519255
PATIENT INT.
Descripción

Patient initial

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Descripción

Patient id

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
DATE OF REPORT
Descripción

DATE OF REPORT

Tipo de datos

date

Alias
UMLS CUI [1]
C1302584
EVENT / ILLNESS
Descripción

SERIOUS ADVERSE EVENTS

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
ONSET DATE
Descripción

ONSET DATE

Tipo de datos

date

Alias
UMLS CUI [1]
C0574845
EVENT RESOLVED?
Descripción

Resolution adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514893
UMLS CUI [1,2]
C0877248
RESOLVED DATE
Descripción

Resolution Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985858
FREQUENCY
Descripción

FREQUENCY

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439603
SEVERITY
Descripción

Severity of adverse event

Tipo de datos

integer

Alias
UMLS CUI [1]
C1710066
RELATIONSHIP TO DISEASE
Descripción

Disease Serious Adverse Event

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
RELATIONSHIP TO STUDY DRUG
Descripción

study drug Serious Adverse Event

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519255
ACTION TAKEN STUDY DRUG ADMINISTRATION
Descripción

ACTION TAKEN STUDY DRUG

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0304229
ACTION TAKEN TREATMENT- NONE
Descripción

ACTION TAKEN

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826626
ACTION TAKEN TREATMENT- MEDICATION
Descripción

ACTION TAKEN MEDICATION

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0013227
ACTION TAKEN TREATMENT- PROCEDURE/ SURGERY (COMMENT BELOW)
Descripción

ACTION TAKEN SURGERY

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0543467
ACTION TAKEN TREATMENT- OTHER
Descripción

ACTION TAKEN OTHER

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0205394
OTHER
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
COMMENT
Descripción

comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
HOSPITALIZATION?
Descripción

Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019993
ADMIT DATE
Descripción

Admission date

Tipo de datos

date

Alias
UMLS CUI [1]
C1302393
DISCHARGE DATE
Descripción

Discharge Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2361123
EVENT CHRONOLOGY: (DESCRIBE ASSOCIATED SIGNS AND SYMPTOMS, CLINICAL COURSE AND OUTCOME)
Descripción

Chronology Severity of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008717
UMLS CUI [1,2]
C1710066
TREATMENT(S) (OTHER THAN MEDICATIONS) FOR THE SERIOUS ADVERSE EVENT, IF RENDERED:
Descripción

therapy Severity of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1710066
DIAGNOSTIC TEST(S) RESULTS PERTAINING TO THE SERIOUS ADVERSE EVENT
Descripción

diagnostic test Severity of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0086143
UMLS CUI [1,2]
C1710066
MEDICAL HISTORY THAT MAY HAVE CONTRIBUTED TO THE SERIOUS ADVERSE EVENT
Descripción

medical history Severity of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1710066
IF THE STUDY DRUG WAS HELD AND LATER RESTARTED, DID THE SAME ADVERSE EVENT RECUR?
Descripción

Recurrence Severity of Adverse Event

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C1710066
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Similar models

SERIOUS ADVERSE EVENTS

1 formularios
  1. StudyEvent: ODM
    1. SERIOUS ADVERSE EVENTS
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
SERIOUS ADVERSE EVENTS
C1519255 (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 REPORT
Item
DATE OF REPORT
date
C1302584 (UMLS CUI [1])
SERIOUS ADVERSE EVENTS
Item
EVENT / ILLNESS
text
C1519255 (UMLS CUI [1])
ONSET DATE
Item
ONSET DATE
date
C0574845 (UMLS CUI [1])
Resolution adverse event
Item
EVENT RESOLVED?
boolean
C1514893 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Resolution Date
Item
RESOLVED DATE
date
C2985858 (UMLS CUI [1])
Item
FREQUENCY
integer
C0439603 (UMLS CUI [1])
FREQUENCY
Code List
FREQUENCY
CL Item
INTERMITTENT (1)
CL Item
CONTINUOUS (2)
Item
SEVERITY
integer
C1710066 (UMLS CUI [1])
Severity of adverse event
Code List
SEVERITY
CL Item
MILD (1)
CL Item
MODERATE (2)
CL Item
SEVERE (3)
Item
RELATIONSHIP TO DISEASE
integer
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Disease Serious Adverse Event
Code List
RELATIONSHIP TO DISEASE
CL Item
NOT RELATED (1)
CL Item
POSSIBLE (2)
CL Item
PROBABLE (3)
Item
RELATIONSHIP TO STUDY DRUG
integer
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Disease Serious Adverse Event
Code List
RELATIONSHIP TO STUDY DRUG
CL Item
NOT RELATED (1)
CL Item
POSSIBLE (2)
CL Item
PROBABLE (3)
Item
ACTION TAKEN STUDY DRUG ADMINISTRATION
integer
C2826626 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
ACTION TAKEN STUDY DRUG
Code List
ACTION TAKEN STUDY DRUG ADMINISTRATION
CL Item
NO CHANGE (1)
CL Item
DOSE MODIFIED (2)
CL Item
HELD (3)
CL Item
DISCONTINUED (4)
ACTION TAKEN
Item
ACTION TAKEN TREATMENT- NONE
boolean
C2826626 (UMLS CUI [1])
ACTION TAKEN MEDICATION
Item
ACTION TAKEN TREATMENT- MEDICATION
boolean
C2826626 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
ACTION TAKEN SURGERY
Item
ACTION TAKEN TREATMENT- PROCEDURE/ SURGERY (COMMENT BELOW)
boolean
C2826626 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
ACTION TAKEN OTHER
Item
ACTION TAKEN TREATMENT- OTHER
boolean
C2826626 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other
Item
OTHER
text
C0205394 (UMLS CUI [1])
comment
Item
COMMENT
text
C0947611 (UMLS CUI [1])
Hospitalization
Item
HOSPITALIZATION?
boolean
C0019993 (UMLS CUI [1])
Admission date
Item
ADMIT DATE
date
C1302393 (UMLS CUI [1])
Discharge Date
Item
DISCHARGE DATE
date
C2361123 (UMLS CUI [1])
Chronology Severity of Adverse Event
Item
EVENT CHRONOLOGY: (DESCRIBE ASSOCIATED SIGNS AND SYMPTOMS, CLINICAL COURSE AND OUTCOME)
text
C0008717 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
therapy Severity of Adverse Event
Item
TREATMENT(S) (OTHER THAN MEDICATIONS) FOR THE SERIOUS ADVERSE EVENT, IF RENDERED:
text
C0087111 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
diagnostic test Severity of Adverse Event
Item
DIAGNOSTIC TEST(S) RESULTS PERTAINING TO THE SERIOUS ADVERSE EVENT
text
C0086143 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
medical history Severity of Adverse Event
Item
MEDICAL HISTORY THAT MAY HAVE CONTRIBUTED TO THE SERIOUS ADVERSE EVENT
text
C0262926 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Item
IF THE STUDY DRUG WAS HELD AND LATER RESTARTED, DID THE SAME ADVERSE EVENT RECUR?
integer
C0034897 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
undefined item
Code List
IF THE STUDY DRUG WAS HELD AND LATER RESTARTED, DID THE SAME ADVERSE EVENT RECUR?
CL Item
YES (1)
CL Item
NO (2)
CL Item
NOT APPLICABLE (3)
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