ID

38958

Description

Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Keywords

Versions (1)
  1. 11/15/19 11/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

English

Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

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

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Description

If Yes, record each medication on a separate line using Trade Names where possible.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Concomitant Medication - Unit Dose
Description

Concomitant Medication - Unit Dose

Data type

float

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0869039
Concomitant Medications - Units
Description

Concomitant Medications - Units

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Concomitant Medication - Frequency
Description

Concomitant Medication - Frequency

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3476109
Concomitant Medication - Route
Description

Concomitant Medication - Route

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Concomitant Medication - Reason for Medication
Description

Concomitant Medication - Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0013227
Conocmitant Medication - Start Date
Description

Conocmitant Medication - Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Conocmitant Medication - Start Time
Description

Conocmitant Medication - Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2347852
Concomitant Medication - Taken prior to Study?
Description

Concomitant Medication - Taken prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Conocmitant Medication - Stop Date
Description

Conocmitant Medication - Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Concomitant Medication - Stop Time
Description

Concomitant Medication - Stop Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522314
Concomitant Medication - Ongoing Medication?
Description

Concomitant Medication - Ongoing Medication?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Non-Serious adverse Events
Description

Non-Serious adverse Events

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

If Yes, record details below.

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious adverse Events
Description

Non-Serious adverse Events

Alias
UMLS CUI-1
C1518404
Non-serious Adverse Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C1518404
Non-serious Adverse Event Start Date
Description

Non-serious Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C1518404
Non-serious Adverse Event Start Time
Description

Non-serious Adverse Event Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Non-serious Adverse Event Outcome
Description

Non-serious Adverse Event Outcome

Data type

integer

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

Non-serious Adverse Event End Date

Data type

date

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C1518404
Non-serious Adverse Event End Time
Description

Non-serious Adverse Event End Time

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Non-serious Adverse Event Frequency
Description

Non-serious Adverse Event Frequency

Data type

integer

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

Non-serious Adverse Event Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Description

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

Data type

text

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

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Serious Adverse Event
Description

Serious Adverse Event

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

If Yes, record details below.

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Section 1
Description

Serious Adverse Event - Section 1

Alias
UMLS CUI-1
C1519255
Serious Adverse Event
Description

Diagnosis Only (if known ) Otherwise Sign/Symptom

Data type

text

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

Serious Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C1519255
Serious Adverse Event Start Time
Description

Serious Adverse Event Start Time

Data type

time

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

Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event End Date
Description

Serious Adverse Event End Date

Data type

date

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C1519255
Serious Adverse Event End Time
Description

Serious Adverse Event End Time

Data type

time

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

Serious Adverse Event Maximum Intensity

Data type

text

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

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

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

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
If fatal, was a post-mortem/autopsy performed
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Serious Adverse Event - Section 2 Seriousness
Description

Serious Adverse Event - Section 2 Seriousness

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

Check all that apply:

Data type

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
If other reason for considering this a SAE, specify
Description

If other reason for considering this a SAE, specify

Data type

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Serious Adverse Event - Section 3 Demography Data
Description

Serious Adverse Event - Section 3 Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Serious Adverse Event - Section 4
Description

Serious Adverse Event - Section 4

Alias
UMLS CUI-1
C1519255
If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
Description

If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0457454
Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s)
Description

Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
UMLS CUI-3
C0304229
UMLS CUI-4
C0205394
Possible Causes of SAE Other Than Investigational Product(s)
Description

Check all that apply:

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0205394
Specify medical conditions
Description

Specify medical conditions

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Specify concomitant medication(s)
Description

Specify concomitant medication(s)

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348235
If other cause of SAE, specify
Description

If other cause of SAE, specify

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Serious Adverse Event - Section 6 Relevant medical Conditions
Description

Serious Adverse Event - Section 6 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 that can help explain the SAE.
Description

Ensure each medical condition recorded in this section is also recorded in the appropriate Medical Conditions form

Data type

text

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

Medical condition - Date of Onset

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Medical condition - Condition Present at Time of the SAE?
Description

Medical condition - Condition Present at Time of the SAE?

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
If Condition is Present at Time of the SAE, Date of Last Occurence
Description

If Condition is Present at Time of the SAE, Date of Last Occurence

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
UMLS CUI [2,1]
C1517741
UMLS CUI [2,2]
C2745955
UMLS CUI [2,3]
C0011008
Serious Adverse Event - Section 7 Other relevant Risk Factors
Description

Serious Adverse Event - Section 7 Other relevant Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
UMLS CUI-3
C0205394
Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
Description

Ensure each concomitant medication recorded in this section is also recorded in the Concomitant Medication form.

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522508
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0681841
UMLS CUI [3,1]
C0085978
UMLS CUI [3,2]
C1519255
UMLS CUI [4,1]
C2981656
UMLS CUI [4,2]
C1519255
Serious Adverse Event - Section 8 Relevant Concomitant Medications
Description

Serious Adverse Event - Section 8 Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
SAE Concomitant Medication - Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
SAE Concomitant Medication - Dose
Description

SAE Concomitant Medication - Dose

Data type

float

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
SAE Concomitant Medication - Unit
Description

SAE Concomitant Medication - Unit

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439148
SAE Concomitant Medication - Frequency
Description

SAE Concomitant Medication - Frequency

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3476109
SAE Concomitant Medication - Route
Description

SAE Concomitant Medication - Route

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
SAE Concomitant Medication - Taken Prior to Study?
Description

SAE Concomitant Medication - Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826667
SAE Concomitant Medication - Start Date
Description

SAE Concomitant Medication - Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826734
SAE Concomitant Medication - Stop Date
Description

SAE Concomitant Medication - Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826744
SAE Concomitant Medication - Ongoing Medication?
Description

SAE Concomitant Medication - Ongoing Medication?

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
SAE Concomitant Medication - Reason for Medication
Description

SAE Concomitant Medication - Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826696
Serious Adverse Event - Section 9 Details of Investigational Product(s)
Description

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

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
UMLS CUI-3
C1522508
Details of Investigational Product(s)
Description

Details of Investigational Product(s)

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1522508
Was treatment blind broken at investigational site?
Description

Was treatment blind broken at investigational site?

Data type

text

Alias
UMLS CUI [1]
C3897431
Serious Adverse Event - Section 10 Details of relevant Assessments
Description

Serious Adverse Event - Section 10 Details of relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
UMLS CUI-3
C1522508
Details of relevant Assessments
Description

Provide details of any tests or procedures carried out to diagnose or confirm the SAE (e.g., laboratory data with units and normal range) if data for this SAE have not been previously entered, and the CRF includes a page for the test, ensure the data is also entered on the page.

Data type

text

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

Serious Adverse Event - Section 11 Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Serious Adverse Event - Narrative Remarks
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator's signature
Description

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

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

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name (print)
Description

Investigator’s name (print)

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator's signature - Date
Description

Investigator's signature - Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Concomitant Medications
C2347852 (UMLS CUI-1)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Concomitant Medication - Unit Dose
Item
Concomitant Medication - Unit Dose
float
C2347852 (UMLS CUI [1,1])
C0869039 (UMLS CUI [1,2])
Item
Concomitant Medications - Units
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Concomitant Medications - Units
Code List
Concomitant Medications - Units
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Concomitant Medication - Frequency
text
C2347852 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
Concomitant Medication - Frequency
Code List
Concomitant Medication - Frequency
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Concomitant Medication - Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Medication - Route
Code List
Concomitant Medication - Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Concomitant Medication - Reason for Medication
Item
Concomitant Medication - Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Conocmitant Medication - Start Date
Item
Conocmitant Medication - Start Date
date
C2826734 (UMLS CUI [1])
Conocmitant Medication - Start Time
Item
Conocmitant Medication - Start Time
time
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication - Taken prior to Study?
Item
Concomitant Medication - Taken prior to Study?
boolean
C2826667 (UMLS CUI [1])
Conocmitant Medication - Stop Date
Item
Conocmitant Medication - Stop Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication - Stop Time
Item
Concomitant Medication - Stop Time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Concomitant Medication - Ongoing Medication?
Item
Concomitant Medication - Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Item Group
Non-Serious adverse Events
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 Events
C1518404 (UMLS CUI-1)
Non-serious Adverse Event
Item
Non-serious Adverse Event
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event Start Date
Item
Non-serious Adverse Event Start Date
date
C2697888 (UMLS CUI [1,1])
C1518404 (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/ Resolvedmwith sequelae (4)
Non-serious Adverse Event End Date
Item
Non-serious Adverse Event End Date
date
C2697886 (UMLS CUI [1,1])
C1518404 (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 [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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 [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item Group
Serious Adverse Event
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])
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
C2697888 (UMLS CUI [1,1])
C1519255 (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/ Resolvedmwith sequelae  (4)
CL Item
Fatal (5)
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C2697886 (UMLS CUI [1,1])
C1519255 (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 [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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 that the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
If fatal, was a post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Section 2 Seriousness
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])
Serious Adverse Event - Section 2 Seriousness
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 ( see definition of SAE ) (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
CL Item
Is associated with liver injury and impaired liver function (G)
If other reason for considering this a SAE, specify
Item
If other reason for considering this a SAE, specify
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Event - Section 3 Demography Data
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
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
Female (F)
CL Item
Male (M)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious Adverse Event - Section 4
C1519255 (UMLS CUI-1)
Item
If Investigational Product was 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])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
Code List
If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
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 - Section 5 Possible Causes of SAE Other Than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
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) s pecify  (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Specify medical conditions
Item
Specify medical conditions
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specify concomitant medication(s)
Item
Specify concomitant medication(s)
text
C2347852 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If other cause of SAE, specify
Item
If other cause of SAE, specify
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Event - Section 6 Relevant medical Conditions
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
Specify any RELEVANT past or current medical disorders, allergies, surgeries that can help explain the SAE.
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries 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])
Medical condition - Condition Present at Time of the SAE?
Item
Medical condition - Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If Condition is Present at Time of the SAE, Date of Last Occurence
Item
If Condition is Present at Time of the SAE, Date of Last Occurence
date
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1517741 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Item Group
Serious Adverse Event - Section 7 Other relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
Item
Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
text
C2347852 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0681841 (UMLS CUI [2,2])
C0085978 (UMLS CUI [3,1])
C1519255 (UMLS CUI [3,2])
C2981656 (UMLS CUI [4,1])
C1519255 (UMLS CUI [4,2])
Item Group
Serious Adverse Event - Section 8 Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
SAE Concomitant Medication - Drug Name
Item
SAE Concomitant Medication - Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
SAE Concomitant Medication - Dose
Item
SAE Concomitant Medication - Dose
float
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
SAE Concomitant Medication - Unit
Item
SAE Concomitant Medication - Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
SAE Concomitant Medication - Frequency
Item
SAE Concomitant Medication - Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
SAE Concomitant Medication - Route
Item
SAE Concomitant Medication - Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
SAE Concomitant Medication - Taken Prior to Study?
Item
SAE Concomitant Medication - Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2826667 (UMLS CUI [1,2])
SAE Concomitant Medication - Start Date
Item
SAE Concomitant Medication - Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
SAE Concomitant Medication - Stop Date
Item
SAE Concomitant Medication - Stop Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
SAE Concomitant Medication - Ongoing Medication?
Item
SAE Concomitant Medication - Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
SAE Concomitant Medication - Reason for Medication
Item
SAE Concomitant Medication - Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2826696 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Section 9 Details of Investigational Product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
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 - Section 10 Details of relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
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 - Section 11 Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event - Narrative Remarks
Item
Serious Adverse Event - Narrative Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator’s name (print)
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
Investigator's signature - Date
Item
Investigator's signature - Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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