ID

37116

Descripción

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Palabras clave

Versiones (1)
  1. 3/7/19 3/7/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

3 de julio de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146

Inglés

Serious Adverse Event (SAE)

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Investigator number
Descripción

Investigator Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826689
Treatment number
Descripción

Protocol Treatment Arm, Numbers

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0237753
Subject number
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Did the subject experience any serious adverse events during the study?
Descripción

Serious Adverse Event, During, Clinical Trials

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Demography
Descripción

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Descripción

Patient date of birth

Tipo de datos

text

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Racial group

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Descripción

Body Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Serious Adverse Event
Descripción

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Serious adverse events - Diagnosis only (if known) or signs / symptoms
Descripción

Serious Adverse Event, Diagnosis, Symptoms

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0037088
Date of onset
Descripción

Serious Adverse Event, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Time of onset
Descripción

Serious Adverse Event, Start Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Maximum intensity
Descripción

Serious Adverse Event, Symptom intensity, Maximum

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Outcome
Descripción

Serious Adverse Event, Adverse Event Outcome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Date of resolution or death
Descripción

Serious Adverse Event, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Time of resolution or death
Descripción

Serious Adverse Event, End Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Action taken with investigational product(s) as a result of the SAE
Descripción

Serious Adverse Event, Action taken with study treatment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did subject withdraw from study as a result of this SAE?
Descripción

Serious Adverse Event, Withdraw

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
Descripción

Serious Adverse Event, Relationships, Experimental drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Does the AE meet the definition of serious?
Descripción

Serious Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Possible Causes of SAE other than Investigational Product(s)
Descripción

Possible Causes of SAE other than Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0015127
Possible Causes of SAE other than Investigational Product(s), check all that apply
Descripción

Serious Adverse Event, Etiology aspects

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
Specification
Descripción

Serious Adverse Event, Etiology aspects

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
Seriousness
Descripción

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness, check all that apply
Descripción

Serious Adverse Event, Seriousness of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Specification
Descripción

Serious Adverse Event, Seriousness of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
If fatal, was an autopsy done/to be performed?
Descripción

Serious Adverse Event, Fatal, Autopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Relevant Medical Conditions
Descripción

Relevant Medical Conditions

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
UMLS CUI-3
C2347946
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Descripción

Serious Adverse Event, Disease

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
Date of onset
Descripción

Serious Adverse Event, Disease, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0808070
Condition present at time of the SAE
Descripción

Serious Adverse Event, Disease, During

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0347984
If NO, date of last occurrence
Descripción

Serious Adverse Event, Disease, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0806020
Other Relevant Risk Factors
Descripción

Other Relevant Risk Factors

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

Serious Adverse Event, Risk Factors, Other

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0205394
Details of Investigational Product(s)
Descripción

Details of Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Start Date
Descripción

Serious Adverse Event, Experiment drug, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
Stop Date
Descripción

Serious Adverse Event, Experiment drug, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0806020
Time of dose
Descripción

Serious Adverse Event, Experiment drug, Medication dose, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0040223
Relevant Concomitant Medications
Descripción

Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug (Trade name preferred)
Descripción

Serious Adverse Event, Concomitant Agent, Medication name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Dose
Descripción

Serious Adverse Event, Concomitant Agent, Medication dose

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
Unit
Descripción

Serious Adverse Event, Concomitant Agent, Unit

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439148
Frequency
Descripción

Serious Adverse Event, Concomitant Agent, Frequencies

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Descripción

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Date started
Descripción

Serious Adverse Event, Concomitant Agent, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Check if started Pre-study
Descripción

Serious Adverse Event, Concomitant Agent, Before, Clinical Trial Period

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
Date stopped
Descripción

Serious Adverse Event, Concomitant Agent, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Check if continued Post-SAE
Descripción

Serious Adverse Event, Concomitant Agent, Continuous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0549178
Conditions treated / indication
Descripción

Serious Adverse Event, Concomitant Agent, Indication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Narrative / Comments
Descripción

Narrative / Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Provide a textual description of the serious adverse event (including treatment of the event).
Descripción

Serious Adverse Event, Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Details of relevant Assessments
Descripción

Details of relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
UMLS CUI-3
C1522508
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
Descripción

Serious Adverse Event, Evaluation, Details

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1522508
Reporting Investigator
Descripción

Reporting Investigator

Alias
UMLS CUI-1
C2346576
Name
Descripción

Investigator Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Address
Descripción

Clinical Investigator, Address

Tipo de datos

text

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

To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

Investigator Signature, Date in time

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
C1519255
UMLS CUI-2
C1546922
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages.
Descripción

Serious Adverse Event, Additional Information

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1546922
Reporting Investigator
Descripción

Reporting Investigator

Alias
UMLS CUI-1
C0008961
Name
Descripción

Investigator Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Address
Descripción

Clinical Investigator, Address

Tipo de datos

text

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

To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

Investigator Signature, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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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)
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Protocol Treatment Arm, Numbers
Item
Treatment number
integer
C1522541 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Serious Adverse Event, During, Clinical Trials
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of birth
text
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
White (1)
CL Item
Asian (2)
CL Item
Black (3)
CL Item
American Hispanic (4)
CL Item
Other (5)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event, Diagnosis, Symptoms
Item
Serious adverse events - Diagnosis only (if known) or signs / symptoms
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Serious Adverse Event, Start Date
Item
Date of onset
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, Start Time
Item
Time of onset
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Symptom intensity, Maximum
Code List
Maximum intensity
CL Item
Mild (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Symptom intensity, Maximum
Code List
Outcome
CL Item
Resolved (1)
CL Item
Resolved with sequelae (2)
CL Item
Fatal (3)
CL Item
Not resolved (4)
Serious Adverse Event, End Date
Item
Date of resolution or death
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Time
Item
Time of resolution or death
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the SAE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action taken with study treatment
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
None (1)
CL Item
Dose adjusted  (2)
CL Item
Temporarily interrupted  (3)
CL Item
Permanently discontinued  (4)
CL Item
Not applicable (5)
Serious Adverse Event, Withdraw
Item
Did subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event
Item
Does the AE meet the definition of serious?
boolean
C1519255 (UMLS CUI [1])
Item Group
Possible Causes of SAE other than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0015127 (UMLS CUI-2)
Item
Possible Causes of SAE other than Investigational Product(s), check all that apply
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Serious Adverse Event, Etiology aspects
Code List
Possible Causes of SAE other than Investigational Product(s), check all that apply
CL Item
Disease under study  (1)
CL Item
Treatment failure  (2)
CL Item
Withdrawal of investigational product(s) (3)
CL Item
Concomitant disorder, specify (4)
CL Item
Concomitant medication, specify (5)
CL Item
Activity related to study participation (e.g. procedures), specify (6)
CL Item
Other, specify (7)
Item
Specification
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Serious Adverse Event, Etiology aspects
Code List
Specification
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness, check all that apply
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Seriousness, check all that apply
CL Item
Death  (1)
CL Item
Life threatening  (2)
CL Item
Hospitalization required or prolonged (3)
CL Item
Disabling or incapacitating (4)
CL Item
Congenital anomaly (5)
CL Item
Other (see definition) (6)
Item
Specification
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Specification
Serious Adverse Event, Fatal, Autopsy
Item
If fatal, was an autopsy done/to be performed?
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item Group
Relevant Medical Conditions
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
Serious Adverse Event, Disease
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Start Date
Item
Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Disease, During
Item
Condition present at time of the SAE
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Serious Adverse Event, Disease, End Date
Item
If NO, date of last occurrence
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Other Relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Serious Adverse Event, Risk Factors, Other
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C1519255 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Details of Investigational Product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Serious Adverse Event, Experiment drug, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Experiment drug, End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Experiment drug, Medication dose, Time
Item
Time of dose
time
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug (Trade name preferred)
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication dose
Item
Dose
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Date started
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Before, Clinical Trial Period
Item
Check if started Pre-study
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Serious Adverse Event, Concomitant Agent, End Date
Item
Date stopped
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Continuous
Item
Check if continued Post-SAE
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Indication
Item
Conditions treated / indication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Narrative / Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Provide a textual description of the serious adverse event (including treatment of the event).
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Details of relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Serious Adverse Event, Evaluation, Details
Item
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item Group
Reporting Investigator
C2346576 (UMLS CUI-1)
Investigator Name
Item
Name
text
C2826892 (UMLS CUI [1])
Clinical Investigator, Address
Item
Address
text
C0008961 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Additional or follow-up information
C1519255 (UMLS CUI-1)
C1546922 (UMLS CUI-2)
Serious Adverse Event, Additional Information
Item
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages.
text
C1519255 (UMLS CUI [1,1])
C1546922 (UMLS CUI [1,2])
Item Group
Reporting Investigator
C0008961 (UMLS CUI-1)
Investigator Name
Item
Name
text
C2826892 (UMLS CUI [1])
Clinical Investigator, Address
Item
Address
text
C0008961 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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