ID

41053

Description

This form documents the serious adverse events which may have occurred during the study. To filled in continuously. If you wish to record a new SAE please determine if the new SAE is clinically or temporally related to an SAE previously entered on this form. If yes, record it in the same instance of the form. If not clinically or temporally related, create a new instance of the SAE form. Do not record pre and post randomization events on the same form. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Link

https://clinicaltrials.gov/ct2/show/NCT00875784

Keywords

Versions (1)
  1. 6/17/20 6/17/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 17, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629

English

Serious Adverse Events

1 forms  
  1. StudyEvent: ODM
    1. Serious Adverse Events
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
TYPE OF REPORT
Description

TYPE OF REPORT

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0585733
1. Initial Report
Description

SAE initial report

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0205265
2. Follow-Up Report
Description

SAE follow-up report

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704685
RANDOMISATION
Description

RANDOMISATION

Alias
UMLS CUI-1
C0034656
3. Did SAE occur after initiation of study medication?
Description

SAE After Experimental Drug Initiation

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C1704686
4. SERIOUS ADVERSE EVENT
Description

4. SERIOUS ADVERSE EVENT

Alias
UMLS CUI-1
C1519255
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

SAE Diagnosis | SAE Sign/Symptom

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0037088
Start Date and Time
Description

Serious Adverse Event Start Date/Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826806
Outcome
Description

Outcome of Serious Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date and Time
Description

This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826793
Maximum Intensity
Description

Maximum Intensity of Serious Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Actions taken with Investigational Product(s) as a Result of the AE
Description

Actions taken with Study Treatment, SAE

Data type

text

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

Patient withdrawn from trial because of SAE

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the AE may have been caused by the investigational product?
Description

Relationship of Experimental Drug to Investigational Product(s)

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Was SAE caused by activities related to study participation (e.g. procedures)?
Description

SAE Caused by Activiteies related to Study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C2348568
5. Seriousness?
Description

5. Seriousness?

Alias
UMLS CUI-1
C1710056
Results in death
Description

SAE results in death

Data type

boolean

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C1519255
Is life-threatening
Description

SAE is life-threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C1517874
UMLS CUI [1,2]
C1519255
Requires hospitalisation or prolongation of existing hospitalisation
Description

SAE requires hospitalisation

Data type

boolean

Alias
UMLS CUI [1,1]
C2826664
UMLS CUI [1,2]
C1519255
Results in disability/incapacity
Description

SAE results in disability/incapacity

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Congenital anomaly/birth defect
Description

SAE: Congenital anomaly/birth defect

Data type

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other, specify within general narrative comment
Description

SAE, other

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
6. RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Description

6. RELEVANT CONCOMITANT/TREATMENT MEDICATIONS

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0304229
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0304229
Dose
Description

Dose of concomitant medication or investigational agent

Data type

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0304229
Unit
Description

Unit of concomitant medication or investigational agent

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C1519795
UMLS CUI [2,2]
C0304229
Frequency
Description

Frequency of concomitant medication or investigational agent

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C3476109
UMLS CUI [2,2]
C0304229
Route
Description

Route of concomitant medication or investigational agent admission

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C0013153
UMLS CUI [2,2]
C0304229
Start Date
Description

Start Date of concomitant medication or investigational agent

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C0808070
UMLS CUI [2,2]
C0304229
Ongoing?
Description

Ongoing concomitant medication or investigational agent

Data type

text

Alias
UMLS CUI [1]
C2826666
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0549178
End Date
Description

Only if Concomitant Medication/Treatment is not ongoing.

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C0806020
UMLS CUI [2,2]
C0304229
Primary Indication
Description

Indication of concomitant medication or investigational agent

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0304229
Drug Type
Description

Drug Type of concomitant medication or investigational agent

Data type

text

Alias
UMLS CUI [1,1]
C0457591
UMLS CUI [1,2]
C2347852
UMLS CUI [2,1]
C0457591
UMLS CUI [2,2]
C0304229
RELEVANT MEDICAL CONDITIONS/RISK FACTORS
Description

RELEVANT MEDICAL CONDITIONS/RISK FACTORS

Alias
UMLS CUI-1
C0262926
7. Specific Condition Name
Description

Relevant Medical Conditions

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of onset
Description

Date of onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Continuing?
Description

Disease Continuing

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
Date of Last Occurrence
Description

Only to be filled in if the Condition is not continuing

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C2745955
UMLS CUI [2,4]
C0011008
8. Relevant Medical History / Risk Factors not noted above
Description

Relevance of Other Medical History/Risk Factors

Data type

text

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0035648
9. RELEVANT DIAGNOSTIC RESULTS
Description

9. RELEVANT DIAGNOSTIC RESULTS

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0430022
Test Name
Description

Diagnostic Procedure Name

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C2826273
Test Date
Description

Test Date

Data type

text

Alias
UMLS CUI [1]
C2826247
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0456984
Test Units
Description

Test Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0430022
Normal Low Range
Description

Normal Low Range

Data type

text

Alias
UMLS CUI [1]
C1272773
Normal High Range
Description

Normal High Range

Data type

text

Alias
UMLS CUI [1]
C1299400
10. Relevant diagnostic results not noted above
Description

Other Diagnostic procedure Result

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
INVESTIGATIONAL PRODUCTS
Description

INVESTIGATIONAL PRODUCTS

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0013230
11. If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Description

Recurrence of the reported SAE following new administration | administration of investigational agent interrupted earlier

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0231290
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C1533734
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C1512900
GENERAL NARRATIVE COMMENTS
Description

GENERAL NARRATIVE COMMENTS

Alias
UMLS CUI-1
C0947611
12. General narrative comments
Description

Comment on SAE

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
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Similar models

Serious Adverse Events

1 forms
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
TYPE OF REPORT
C1519255 (UMLS CUI-1)
C0585733 (UMLS CUI-2)
SAE initial report
Item
1. Initial Report
boolean
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
SAE follow-up report
Item
2. Follow-Up Report
boolean
C1519255 (UMLS CUI [1,1])
C1704685 (UMLS CUI [1,2])
Item Group
RANDOMISATION
C0034656 (UMLS CUI-1)
SAE After Experimental Drug Initiation
Item
3. Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1704686 (UMLS CUI [1,4])
Item Group
4. SERIOUS ADVERSE EVENT
C1519255 (UMLS CUI-1)
SAE Diagnosis | SAE Sign/Symptom
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Serious Adverse Event Start Date/Time
Item
Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C2826806 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date and Time (Recovered/Resolved, provide End Date and Time)
CL Item
Recovering/Resolving (Recovering/Resolving)
CL Item
Not recovered/Not resolved (Not recovered/Not resolved)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (Recovered/Resolved with sequelae, provide End Date and Time)
CL Item
Fatal, record Date and Time of Death (Fatal, record Date and Time of Death)
SAE End Date Time
Item
End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
Actions taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Actions taken with Investigational Product(s) as a Result of the SAE
Code List
Actions taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
Patient withdrawn from trial because of SAE
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship of Experimental Drug to Investigational Product(s)
Item
Is there a reasonable possibility the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
SAE Caused by Activiteies related to Study participation
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Item Group
5. Seriousness?
C1710056 (UMLS CUI-1)
SAE results in death
Item
Results in death
boolean
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE is life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE requires hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C2826664 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE: Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE, other
Item
Other, specify within general narrative comment
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Item Group
6. RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
C2347852 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Name of concomitant medication or investigational agent
Item
Drug Name
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Dose of concomitant medication or investigational agent
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Unit of concomitant medication or investigational agent
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Frequency of concomitant medication or investigational agent
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Route of concomitant medication or investigational agent admission
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Start Date of concomitant medication or investigational agent
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
C0304229 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Ongoing Medication
Code List
Ongoing?
CL Item
Yes (Yes)
CL Item
No, specify End Date (No, specify End Date)
End Date of concomitant medication or investigational agent
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Indication of concomitant medication or investigational agent
Item
Primary Indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Drug Type of concomitant medication or investigational agent
Item
Drug Type
text
C0457591 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0457591 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Item Group
RELEVANT MEDICAL CONDITIONS/RISK FACTORS
C0262926 (UMLS CUI-1)
Relevant Medical Conditions
Item
7. Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
SAE, Status, Current
Code List
Continuing?
CL Item
Yes (Yes)
CL Item
No, specify date of last occurence (No, specify date of last occurence)
CL Item
Unknown (Unknown)
Date of Last Occurrence of Disease or Risk Factors
Item
Date of Last Occurrence
date
C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0035648 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,4])
Relevance of Other Medical History/Risk Factors
Item
8. Relevant Medical History / Risk Factors not noted above
text
C2347946 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
Item Group
9. RELEVANT DIAGNOSTIC RESULTS
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
Diagnostic Procedure Name
Item
Test Name
text
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
Test Date
Item
Test Date
text
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0456984 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C1272773 (UMLS CUI [1])
Normal High Range
Item
Normal High Range
text
C1299400 (UMLS CUI [1])
Other Diagnostic procedure Result
Item
10. Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
INVESTIGATIONAL PRODUCTS
C1828479 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
Item
11. If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
C0231290 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1512900 (UMLS CUI [2,3])
Recurrence of the reported SAE in case of discontinuation of the investigational product
Code List
11. If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
GENERAL NARRATIVE COMMENTS
C0947611 (UMLS CUI-1)
Comment on SAE
Item
12. General narrative comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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