ID

41482

Descripción

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 - See https://clinicaltrials.gov/ct2/show/NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. The Serious Adverse Event (SAE) Form has to be filled in each time when such Event occurs throughout the course of the Study.

Link

https://clinicaltrials.gov/ct2/show/NCT00039858

Palabras clave

Versiones (1)
  1. 24/10/20 24/10/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

24 de octubre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

Inglés

Serious Adverse Event (SAE)

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Descripción

Study centre number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient #
Descripción

patient ID

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Descripción

Investigator Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Did the patient experience any serious adverse events during the study?
Descripción

Did the patient experience any serious adverse events during the study?

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0347984
UMLS CUI-3
C2347804
Did the patient experience any serious adverse events during the study?
Descripción

If Yes, please complete below.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
SECTION 1 Demography
Descripción

SECTION 1 Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Sex

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
If other race, please specify:
Descripción

Other race - specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C3845569
Weight
Descripción

Weight

Tipo de datos

float

Alias
UMLS CUI [1]
C0005910
Weight - unit
Descripción

Weight unit

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1519795
Height
Descripción

Height

Tipo de datos

float

Alias
UMLS CUI [1]
C0005890
Height - unit
Descripción

Height unit

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C1519795
SECTION 2 Serious Adverse Events
Descripción

SECTION 2 Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Sequential number
Descripción

Sequential number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Serious Adverse Events
Descripción

Diagnosis only (if known) OR Serious signs/symptoms (list one per line)

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Date of Onset
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
Time of Onset
Descripción

(0000-2359)

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
Maximum Intensity
Descripción

Maximum intensity of SAE

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Outcome
Descripción

Outcome of SAE

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Date of Resolution or Death
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1]
C2985918
UMLS CUI [2]
C1148348
Action Taken with Investigational Product as a Result of the SAE
Descripción

Action taken with study treatment because of SAE

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Withdrawal
Descripción

Did the patient withdraw from study as a result of this SAE?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0877248
Relationship to Investigational Product(s)
Descripción

Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Seriousness?
Descripción

Does the AE meet the definition of serious? Only Option 1 can be chosen as Answer.

Tipo de datos

integer

Alias
UMLS CUI [1]
C1710056
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
Descripción

SECTION 3 Possible Causes of SAE other than Investigational Product(s)

Alias
UMLS CUI-1
C3641099
UMLS CUI-2
C1519255
Disease under study
Descripción

Disease under study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Treatment failure
Descripción

Treatment failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162643
Withdrawal of investigational product
Descripción

Withdrawal of investigational product

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant disorder (specify)
Descripción

Concomitant disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
Concomitant disorder - specify:
Descripción

Concomitant disorder - specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1521902
Concomitant medication (specify)
Descripción

Concomitant medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant medication - specify:
Descripción

Concomitant medication - specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1521902
Activity related to study participation (e.g., procedures) (specify)
Descripción

Activity related to study participation, procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0199171
Activity related to study participation (e.g., procedures) - specify:
Descripción

Activity related to study participation, procedures - specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1521902
UMLS CUI [2,1]
C0199171
UMLS CUI [2,2]
C1521902
Other (specify)
Descripción

Other cause of SAE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0205394
Other - specify:
Descripción

Other cause of SAE - specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1521902
SECTION 4 Seriousness
Descripción

SECTION 4 Seriousness

Alias
UMLS CUI-1
C1710056
Death
Descripción

If Yes, fill the following Question

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011065
If fatal, was an autopsy done/to be performed?
Descripción

(Send autopsy report when available.)

Tipo de datos

text

Alias
UMLS CUI [1]
C1705232
UMLS CUI [2]
C0004398
Life threatening
Descripción

Life threatening AE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1517874
Hospitalization required or prolonged
Descripción

Hospitalization required or prolonged

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348993
Disabling or incapacitating
Descripción

Disabling AE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3830477
Congenital anomaly
Descripción

AE seriousness due to congenital anomaly

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826727
Other (SAE definition) (specify)
Descripción

Other SAE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
Other (SAE definition) - specify
Descripción

Other SAE - specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
SECTION 5 Relevant Medical Conditions
Descripción

SECTION 5 Relevant Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C1519255
Sequential number
Descripción

Sequential number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Descripción

Medical history, allergies, surgeries relevant to SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1519255
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1519255
Date of Onset
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
Condition Present at Time of the SAE?
Descripción

Disease present during SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1519255
If ‘NO’, Date of Last Occurrence
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0009488
SECTION 6 Other Relevant Risk Factors
Descripción

SECTION 6 Other Relevant Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
UMLS CUI-3
C0205394
UMLS CUI-4
C2347946
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Descripción

Risk factors relevant to SAE (social history, family history, smoking, alcohol, diet, drug abuse, occupational hazard)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2347946
UMLS CUI [2]
C3714536
UMLS CUI [3]
C0241889
UMLS CUI [4]
C0543414
UMLS CUI [5]
C0001948
UMLS CUI [6]
C0012155
UMLS CUI [7]
C0013146
UMLS CUI [8]
C0337074
SECTION 7 Details of Investigational Product(s)
Descripción

SECTION 7 Details of Investigational Product(s)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1522508
Investigational Product
Descripción

Investigational product

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Date of First Dose
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3173309
Date of Last Dose
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
SECTION 8 Relevant Concomitant Medications
Descripción

SECTION 8 Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Sequential number
Descripción

Sequential number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Drug
Descripción

(Trade Name Preferred)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Dose
Descripción

Concomitant medication dose

Tipo de datos

float

Alias
UMLS CUI [1]
C2826811
Unit
Descripción

Concomitant medication dose unit

Tipo de datos

text

Alias
UMLS CUI [1]
C2826646
Frequency
Descripción

Concomitant medication dose frequency

Tipo de datos

text

Alias
UMLS CUI [1]
C2826654
Route
Descripción

Concomitant medication route of administration

Tipo de datos

text

Alias
UMLS CUI [1]
C2826730
Date Started
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1]
C2826734
Check if started Pre-study
Descripción

Concomitant medication started pre-study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2981448
Date Stopped
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1]
C2826744
Check if continued Post-SAE
Descripción

Concomitant medication continued post-SAE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C1519255
Conditions treated / indication
Descripción

Concomintant medication indication

Tipo de datos

text

Alias
UMLS CUI [1]
C2826696
SECTION 9 Narrative / Comments
Descripción

SECTION 9 Narrative / Comments

Alias
UMLS CUI-1
C0947611
Provide a textual description of the serious adverse event (including treatment of the event).
Descripción

Description of SAE | description of AE treatment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
UMLS CUI [2,1]
C2981656
UMLS CUI [2,2]
C0678257
SECTION 10 Details of Relevant Assessments
Descripción

SECTION 10 Details of Relevant Assessments

Alias
UMLS CUI-1
C1261322
UMLS CUI-2
C1519255
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
Descripción

Details of other evaluation of SAE, laboratory procedures

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1522508
UMLS CUI [2]
C0022885
SECTION 11 Reporting Investigator
Descripción

SECTION 11 Reporting Investigator

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1533716
Form section signed
Descripción

This Section should be filled in once for Sections 1-10 and eventually once for Additional or Follow-Up Information.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C1828479
Name (print)
Descripción

Investigator name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Address
Descripción

Investigator address

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0008961
Signature
Descripción

Investigator signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Additional or Follow-Up Information
Descripción

Additional or Follow-Up Information

Alias
UMLS CUI-1
C1524062
UMLS CUI-2
C1533716
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
Use this field to provide any additional details on the serious adverse event not already captured on the previous forms. The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
Descripción

Additional or Follow-Up Information

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C1519255
UMLS CUI [2,1]
C1522577
UMLS CUI [2,2]
C1533716
UMLS CUI [2,3]
C1519255
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Similar models

Serious Adverse Event (SAE)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Item Group
Did the patient experience any serious adverse events during the study?
C1519255 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
Item
Did the patient experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
SAE during study
Code List
Did the patient experience any serious adverse events during the study?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
SECTION 1 Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Asian (Asian)
CL Item
Black (Black)
CL Item
Caucasian (Caucasian)
CL Item
Hispanic (Hispanic)
CL Item
Other (specify) (Other (specify))
Item
If other race, please specify:
text
C0034510 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Race
Code List
If other race, please specify:
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Weight - unit
text
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Weight unit
Code List
Weight - unit
CL Item
lbs (lbs)
CL Item
kg (kg)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item
Height - unit
text
C0005890 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Height unit
Code List
Height - unit
CL Item
in (in)
CL Item
cm (cm)
Item Group
SECTION 2 Serious Adverse Events
C1519255 (UMLS CUI-1)
Sequential number
Item
Sequential number
integer
C2348184 (UMLS CUI [1])
SAE
Item
Serious Adverse Events
text
C1519255 (UMLS CUI [1])
Date of onset of SAE
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time of onset of SAE
Item
Time of Onset
time
C0449244 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum intensity of SAE
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome of SAE
Code List
Outcome
CL Item
Resolved (1)
CL Item
Resolved with sequelae (2)
CL Item
Fatal (3)
CL Item
Not resolved (4)
Date of resolution or death
Item
Date of Resolution or Death
date
C2985918 (UMLS CUI [1])
C1148348 (UMLS CUI [2])
Item
Action Taken with Investigational Product as a Result of the SAE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with study treatment because of SAE
Code List
Action Taken with Investigational Product as a Result of the SAE
CL Item
None (0)
CL Item
Drug adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (4)
Item
Withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Withdrawal because of SAE
Code List
Withdrawal
CL Item
Yes (1)
CL Item
No (0)
Item
Relationship to Investigational Product(s)
integer
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Withdrawal because of SAE
Code List
Relationship to Investigational Product(s)
CL Item
Yes (1)
CL Item
No (0)
Item
Seriousness?
integer
C1710056 (UMLS CUI [1])
Withdrawal because of SAE
Code List
Seriousness?
CL Item
Yes (1)
CL Item
No (0)
Item Group
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
C3641099 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Treatment failure
Item
Treatment failure
boolean
C0162643 (UMLS CUI [1])
Withdrawal of investigational product
Item
Withdrawal of investigational product
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant disorder
Item
Concomitant disorder (specify)
boolean
C0009488 (UMLS CUI [1])
Concomitant disorder - specify
Item
Concomitant disorder - specify:
text
C0009488 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Concomitant medication
Item
Concomitant medication (specify)
boolean
C2347852 (UMLS CUI [1])
Concomitant medication - specify
Item
Concomitant medication - specify:
text
C2347852 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Activity related to study participation, procedures
Item
Activity related to study participation (e.g., procedures) (specify)
boolean
C2348568 (UMLS CUI [1])
C0199171 (UMLS CUI [2])
Activity related to study participation, procedures - specify
Item
Activity related to study participation (e.g., procedures) - specify:
text
C2348568 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0199171 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
Other cause of SAE
Item
Other (specify)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other cause of SAE - specify
Item
Other - specify:
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
SECTION 4 Seriousness
C1710056 (UMLS CUI-1)
SAE - Death
Item
Death
boolean
C1519255 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Item
If fatal, was an autopsy done/to be performed?
text
C1705232 (UMLS CUI [1])
C0004398 (UMLS CUI [2])
SAE during study
Code List
If fatal, was an autopsy done/to be performed?
CL Item
Yes (Yes)
CL Item
No (No)
Life threatening AE
Item
Life threatening
boolean
C1517874 (UMLS CUI [1])
Hospitalization required or prolonged
Item
Hospitalization required or prolonged
boolean
C2348993 (UMLS CUI [1])
Disabling AE
Item
Disabling or incapacitating
boolean
C3830477 (UMLS CUI [1])
AE seriousness due to congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Other SAE
Item
Other (SAE definition) (specify)
boolean
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other SAE - specify
Item
Other (SAE definition) - specify
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
SECTION 5 Relevant Medical Conditions
C0262926 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Sequential number
Item
Sequential number
integer
C2348184 (UMLS CUI [1])
Medical history, allergies, surgeries relevant to SAE
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1519255 (UMLS CUI [3,2])
Date of onset of SAE
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Condition Present at Time of the SAE?
text
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
SAE during study
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Yes)
CL Item
No (No)
Date of last occurence of comorbidity
Item
If ‘NO’, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0009488 (UMLS CUI [1,4])
Item Group
SECTION 6 Other Relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
Risk factors relevant to SAE (social history, family history, smoking, alcohol, diet, drug abuse, occupational hazard)
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,4])
C3714536 (UMLS CUI [2])
C0241889 (UMLS CUI [3])
C0543414 (UMLS CUI [4])
C0001948 (UMLS CUI [5])
C0012155 (UMLS CUI [6])
C0013146 (UMLS CUI [7])
C0337074 (UMLS CUI [8])
Item Group
SECTION 7 Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Investigational product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Date of first dose of investigational product
Item
Date of First Dose
date
C0304229 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Date of last dose of investigational product
Item
Date of Last Dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Item Group
SECTION 8 Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Sequential number
Item
Sequential number
integer
C2348184 (UMLS CUI [1])
Concomitant medication name
Item
Drug
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant medication dose
Item
Dose
float
C2826811 (UMLS CUI [1])
Concomitant medication dose unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Concomitant medication dose frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant medication route of administration
Item
Route
text
C2826730 (UMLS CUI [1])
Concomitant medication date started
Item
Date Started
date
C2826734 (UMLS CUI [1])
Concomitant medication started pre-study
Item
Check if started Pre-study
boolean
C2981448 (UMLS CUI [1])
Concomitant medication stop date
Item
Date Stopped
date
C2826744 (UMLS CUI [1])
Concomitant medication continued post-SAE
Item
Check if continued Post-SAE
boolean
C2826666 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Concomintant medication indication
Item
Conditions treated / indication
text
C2826696 (UMLS CUI [1])
Item Group
SECTION 9 Narrative / Comments
C0947611 (UMLS CUI-1)
Description of SAE | description of AE treatment
Item
Provide a textual description of the serious adverse event (including treatment of the event).
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C2981656 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
Item Group
SECTION 10 Details of Relevant Assessments
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Details of other evaluation of SAE, laboratory procedures
Item
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
text
C0220825 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522508 (UMLS CUI [1,4])
C0022885 (UMLS CUI [2])
Item Group
SECTION 11 Reporting Investigator
C0008961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Form section signed
text
C2346576 (UMLS CUI [1,1])
C1828479 (UMLS CUI [1,2])
Document section signed by investigator
Code List
Form section signed
CL Item
Sections 1-10 (Sections 1-10)
CL Item
Additional or Follow-Up Information (Additional or Follow-Up Information)
Investigator name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Investigator address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigator signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Additional or Follow-Up Information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Additional or Follow-Up Information
Item
Use this field to provide any additional details on the serious adverse event not already captured on the previous forms. The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
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