ID

22207

Beschrijving

Study part: 60 Day Post- Treatment 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"

Trefwoorden

Versies (1)
  1. 23-05-17 23-05-17 -
Houder van rechten

Roche

Geüploaded op

23 mei 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

60 DAY POST-TREATMENT SERIOUS ADVERSE EVENTS Roche H0650g Breast Cancer

Engels

60 DAY POST-TREATMENT SERIOUS ADVERSE EVENTS

1 Formulieren  
SERIOUS ADVERSE EVENTS
Beschrijving

SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1519255
PATIENT INT.
Beschrijving

Patient initial

Datatype

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Beschrijving

Patient id

Datatype

integer

Alias
UMLS CUI [1]
C2348585
DATE OF REPORT
Beschrijving

DATE OF REPORT

Datatype

date

Alias
UMLS CUI [1]
C1302584
EVENT / ILLNESS
Beschrijving

SERIOUS ADVERSE EVENTS

Datatype

text

Alias
UMLS CUI [1]
C1519255
ONSET DATE
Beschrijving

ONSET DATE

Datatype

date

Alias
UMLS CUI [1]
C0574845
EVENT RESOLVED?
Beschrijving

Resolution adverse event

Datatype

boolean

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

Resolution Date

Datatype

date

Alias
UMLS CUI [1]
C2985858
FREQUENCY
Beschrijving

FREQUENCY

Datatype

integer

Alias
UMLS CUI [1]
C0439603
SEVERITY
Beschrijving

Severity of adverse event

Datatype

integer

Alias
UMLS CUI [1]
C1710066
RELATIONSHIP TO DISEASE
Beschrijving

Disease Serious Adverse Event

Datatype

integer

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

study drug Serious Adverse Event

Datatype

integer

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

ACTION TAKEN STUDY DRUG

Datatype

integer

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

ACTION TAKEN

Datatype

boolean

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

ACTION TAKEN MEDICATION

Datatype

boolean

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

ACTION TAKEN SURGERY

Datatype

boolean

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

ACTION TAKEN OTHER

Datatype

boolean

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

Other

Datatype

text

Alias
UMLS CUI [1]
C0205394
COMMENT
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
HOSPITALIZATION?
Beschrijving

Hospitalization

Datatype

boolean

Alias
UMLS CUI [1]
C0019993
ADMIT DATE
Beschrijving

Admission date

Datatype

date

Alias
UMLS CUI [1]
C1302393
DISCHARGE DATE
Beschrijving

Discharge Date

Datatype

date

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

Chronology Severity of Adverse Event

Datatype

text

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

therapy Severity of Adverse Event

Datatype

text

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

diagnostic test Severity of Adverse Event

Datatype

text

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

medical history Severity of Adverse Event

Datatype

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?
Beschrijving

Recurrence Severity of Adverse Event

Datatype

integer

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C1710066
Terug naar het begin van de pagina

Similar models

60 DAY POST-TREATMENT SERIOUS ADVERSE EVENTS

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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