ID

42301

Beschreibung

Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

Stichworte

Versionen (2)
  1. 17.05.21 17.05.21 -
  2. 18.05.21 18.05.21 -
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GlaxoSmithKline

Hochgeladen am

18. Mai 2021

DOI

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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812

Englisch

Non-Serious Adverse Events; Serious Adverse Events; SAE Follow-up

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Non-Serious Adverse Event
Beschreibung

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Beschreibung

Did the subject experience any non-serious adverse events during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event
Beschreibung

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Non-Serious Adverse Event Start Date
Beschreibung

Non-Serious Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Event Start Time
Beschreibung

Non-Serious Adverse Event Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Non-Serious Adverse Event Outcome
Beschreibung

Non-Serious Adverse Event Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-Serious Adverse Event End Date
Beschreibung

Non-Serious Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Event End Time
Beschreibung

Non-Serious Adverse Event End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Non-Serious Adverse Event Frequency
Beschreibung

Non-Serious Adverse Event Frequency

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non-Serious Adverse Event Maximum Intensity
Beschreibung

Non-Serious Adverse Event Maximum Intensity

Datentyp

text

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0806909
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschreibung

Action Taken with Investigational Product(s) as a Result of the Non-Serious AE

Datentyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0439849
Serious Adverse Event (Section 1)
Beschreibung

Serious Adverse Event (Section 1)

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Beschreibung

Did the subject experience a serious adverse event during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
If fatal, was a post-mortem/autopsy performed
Beschreibung

If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

Datentyp

boolean

Alias
UMLS CUI [1]
C0004398
UMLS CUI [2]
C1519255
Serious Adverse Event (Section 1)
Beschreibung

Serious Adverse Event (Section 1)

Alias
UMLS CUI-1
C1519255
Serious Adverse Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Start Date
Beschreibung

Serious Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Serious Adverse Event Start Time
Beschreibung

Serious Adverse Event Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Serious Adverse Event Outcome
Beschreibung

Serious Adverse Event Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event End date
Beschreibung

Serious Adverse Event End date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Serious Adverse Event End Time
Beschreibung

Serious Adverse Event End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Serious Adverse Event Maximum Intensity
Beschreibung

Serious Adverse Event Maximum Intensity

Datentyp

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0806909
Action Taken with Investigational Product(s) as a Result of the SAE
Beschreibung

Action Taken with Investigational Product(s) as a Result of the SAE

Datentyp

text

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0439849
Serious Adverse Event - Seriousness (Section 2)
Beschreibung

Serious Adverse Event - Seriousness (Section 2)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Specify reason(s) for considering this a SAE
Beschreibung

Check all that apply.

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
Specify other reason considering this an SAE
Beschreibung

Specify other reason considering this an SAE

Datentyp

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C2348235
Serious Adverse Event - Demography Data (Section 3)
Beschreibung

Serious Adverse Event - Demography Data (Section 3)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Serious Adverse Event - Investigational Product
Beschreibung

Serious Adverse Event - Investigational Product

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0304229
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Beschreibung

If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?

Datentyp

text

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0034897
Serious Adverse Event - Causes (Section 5)
Beschreibung

Serious Adverse Event - Causes (Section 5)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible Causes of SAE Other Than Investigational Product(s)
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [2]
C0205394
Specify other cause of SAE
Beschreibung

Specify other cause of SAE

Datentyp

text

Alias
UMLS CUI [1]
C0085978
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
Serious Adverse Event - RELEVANT Medical Conditions (Section 6)
Beschreibung

Serious Adverse Event - RELEVANT Medical Conditions (Section 6)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0262926
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschreibung

Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE

Datentyp

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
UMLS CUI [4]
C1519255
Medical condition - Date of Onset
Beschreibung

Medical condition - Date of Onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition Present at Time of the SAE?
Beschreibung

Condition Present at Time of the SAE?

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1519255
If condition not present at time of SAE, enter Date of Last Occurrence
Beschreibung

If condition not present at time of SAE, enter Date of Last Occurrence

Datentyp

date

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1519255
UMLS CUI [3,1]
C2745955
UMLS CUI [3,2]
C1517741
UMLS CUI [3,3]
C0011008
Serious Adverse Event - Other RELEVANT Risk Factors (Section 7)
Beschreibung

Serious Adverse Event - Other RELEVANT Risk Factors (Section 7)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0035648
UMLS CUI-4
C0205394
Other RELEVANT Risk Factors
Beschreibung

(provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)

Datentyp

text

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2]
C1519255
Serious Adverse Event - Concomitant Medications (Section 8)
Beschreibung

Serious Adverse Event - Concomitant Medications (Section 8)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C2347852
Drug Name
Beschreibung

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Drug Dose
Beschreibung

Drug Dose

Datentyp

float

Alias
UMLS CUI [1]
C0678766
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Medication Frequency
Beschreibung

Medication Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschreibung

Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Medication taken prior to study?
Beschreibung

Medication taken prior to study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication Stop Date
Beschreibung

Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Serious Adverse Event - Details of Investigational Product(s) (Section 9)
Beschreibung

Serious Adverse Event - Details of Investigational Product(s) (Section 9)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0304229
UMLS CUI-5
C1522508
Details of Investigational Product(s)
Beschreibung

Details of Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Was treatment blind broken at investigational Site?
Beschreibung

Was treatment blind broken at investigational Site?

Datentyp

text

Alias
UMLS CUI [1]
C3897431
Serious Adverse Event - Details of RELEVANT Assessments (Section 10)
Beschreibung

Serious Adverse Event - Details of RELEVANT Assessments (Section 10)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0220825
UMLS CUI-4
C1522508
Details of RELEVANT Assessments
Beschreibung

(provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)

Datentyp

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1522508
Serious Adverse Event - Narrative Remarks (Section 11)
Beschreibung

Serious Adverse Event - Narrative Remarks (Section 11)

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C0947611
Narrative Remarks
Beschreibung

(provide a brief narrative description of the SAE and details of treatment given)

Datentyp

text

Alias
UMLS CUI [1]
C0947611
SAE - Investigator's signature
Beschreibung

SAE - Investigator's signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
Investigator's signature
Beschreibung

(confirming that the data on the SAE pages are accurate and complete)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's signature Date
Beschreibung

Investigator's signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name
Beschreibung

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Serious Adverse Event (SAE) - Additional/ Follow-up Information
Beschreibung

Serious Adverse Event (SAE) - Additional/ Follow-up Information

Alias
UMLS CUI-1
C1519255
UMLS CUI-3
C1522577
UMLS CUI-5
C1524062
UMLS CUI-7
C1533716
Serious Adverse Event (SAE) - Additional/ Follow-up Information
Beschreibung

(use this page to provide any additional details on the SAE not already captured on the previous pages)

Datentyp

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C1522577
UMLS CUI [3]
C1524062
UMLS CUI [4]
C1533716
Investigator's Signature (SAE Follow-up)
Beschreibung

Investigator's Signature (SAE Follow-up)

Alias
UMLS CUI-1
C2346576
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
Investigator's Signature
Beschreibung

(confirming that the data on this page is accurate and complete)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Beschreibung

Investigator's Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name
Beschreibung

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Non-Serious Adverse Events; Serious Adverse Events; SAE Follow-up

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Non-Serious Adverse Event Start Date
Item
Non-Serious Adverse Event Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event Start Time
Item
Non-Serious Adverse Event Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event Outcome
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolvedwith sequelae (4)
Non-Serious Adverse Event End Date
Item
Non-Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event End Time
Item
Non-Serious Adverse Event End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-Serious Adverse Event Frequency
Code List
Non-Serious Adverse Event Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Non-Serious Adverse Event Maximum Intensity
text
C1518404 (UMLS CUI [1])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Non-Serious Adverse Event Maximum Intensity
Code List
Non-Serious Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1])
C2349954 (UMLS CUI [2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
Item Group
Serious Adverse Event (Section 1)
C1519255 (UMLS CUI-1)
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
If fatal, was a post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item Group
Serious Adverse Event (Section 1)
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event Start Time
Item
Serious Adverse Event Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event Outcome
Code List
Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
Serious Adverse Event End date
Item
Serious Adverse Event End date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Serious Adverse Event Maximum Intensity
text
C1519255 (UMLS CUI [1])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Serious Adverse Event Maximum Intensity
Code List
Serious Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the SAE
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
Item Group
Serious Adverse Event - Seriousness (Section 2)
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Specify reason(s) for considering this a SAE
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Specify reason(s) for considering this a SAE
Code List
Specify reason(s) for considering this a SAE
CL Item
Results in death  (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
Specify other reason considering this an SAE
Item
Specify other reason considering this an SAE
text
C1519255 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
Item Group
Serious Adverse Event - Demography Data (Section 3)
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-3)
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 (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious Adverse Event - Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-3)
Item
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
text
C0304229 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0034897 (UMLS CUI [3])
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Code List
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Causes (Section 5)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Possible Causes of SAE Other Than Investigational Product(s)
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Specify other cause of SAE
Item
Specify other cause of SAE
text
C0085978 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item Group
Serious Adverse Event - RELEVANT Medical Conditions (Section 6)
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1519255 (UMLS CUI [4])
Medical condition - Date of Onset
Item
Medical condition - Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
If condition not present at time of SAE, enter Date of Last Occurrence
Item
If condition not present at time of SAE, enter Date of Last Occurrence
date
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
Item Group
Serious Adverse Event - Other RELEVANT Risk Factors (Section 7)
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item Group
Serious Adverse Event - Concomitant Medications (Section 8)
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Drug Dose
Item
Drug Dose
float
C0678766 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication taken prior to study?
Item
Medication taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Item Group
Serious Adverse Event - Details of Investigational Product(s) (Section 9)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-3)
C1522508 (UMLS CUI-5)
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational Site?
text
C3897431 (UMLS CUI [1])
Was treatment blind broken at investigational Site?
Code List
Was treatment blind broken at investigational Site?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Details of RELEVANT Assessments (Section 10)
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Details of RELEVANT Assessments
Item
Details of RELEVANT Assessments
text
C0220825 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Narrative Remarks (Section 11)
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-3)
Narrative Remarks
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1])
Item Group
SAE - Investigator's signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's signature Date
Item
Investigator's signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE) - Additional/ Follow-up Information
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-3)
C1524062 (UMLS CUI-5)
C1533716 (UMLS CUI-7)
Serious Adverse Event (SAE) - Additional/ Follow-up Information
Item
Serious Adverse Event (SAE) - Additional/ Follow-up Information
text
C1519255 (UMLS CUI [1])
C1522577 (UMLS CUI [2])
C1524062 (UMLS CUI [3])
C1533716 (UMLS CUI [4])
Item Group
Investigator's Signature (SAE Follow-up)
C2346576 (UMLS CUI-1)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
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