ID

32856

Beschreibung

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Stichworte

Versionen (4)
  1. 19.10.18 19.10.18 -
  2. 16.11.18 16.11.18 -
  3. 19.01.19 19.01.19 -
  4. 04.03.19 04.03.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. November 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Englisch

Serious Adverse Event Form

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Identifier, Hospitals

Datentyp

integer

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

Randomization, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Serious Adverse Event (SAE)
Beschreibung

Serious Adverse Event (SAE)

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

Serious Adverse Event, During, Clinical Trials

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Event
Beschreibung

Serious Adverse Event, Diagnosis, Signs and Symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0037088
Start Date
Beschreibung

Serious Adverse Event, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Outcome
Beschreibung

Serious Adverse Event, Adverse Event Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date
Beschreibung

Serious Adverse Event, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Maximum Intensity
Beschreibung

Serious Adverse Event, Seriousness of Adverse Event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Action Taken with Investigational Product(s) as a Result of the SAE
Beschreibung

Serious Adverse Event, Action Taken with Study Treatment

Datentyp

integer

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

Serious Adverse Event, Withdrawal by Subject

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710677
Relationship to Investigational Product(s)) - Is there a reasonable possibility the SAE may have been caused by the investigational product?
Beschreibung

Serious Adverse Event, Relationships, Investigational New Drugs

Datentyp

boolean

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

Serious Adverse Event, Fatal, Autopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
Beschreibung

Serious Adverse vent, Seriousness of Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Demography Data
Beschreibung

Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1704791
Date of birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

Serious Adverse Event, Experimental Drug

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Possible Causes
Beschreibung

Possible Causes

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
Beschreibung

Serious Adverse Event, Causations

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Relevant Medical Conditions
Beschreibung

Relevant Medical Conditions

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

Medical History; Hypersensitivity; Operative Surgical Procedures

Datentyp

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
Date of Onset
Beschreibung

Disease, Date of Onset

Datentyp

date

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

Disease, During, Serious Adverse Event

Datentyp

boolean

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

Disease, Occurrence, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
CC2745955
Other Relevant Risk Factors
Beschreibung

Other Relevant Risk Factors

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

Serious Adverse Event, Risk Factors, Medical History, Family History

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0262926
UMLS CUI [1,4]
C0241889
Relevant Concomitant Medications
Beschreibung

Relevant Concomitant Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
Drug Name
Beschreibung

Serious Adverse Event, Concomitant Agent, Medication Name

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Medication Dose

Datentyp

integer

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

Serious Adverse Event, Concomitant Agent, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519795
Frequency
Beschreibung

Serious Adverse Event, Concomitant Agent,, Frequencies

Datentyp

text

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

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Taken Prior to Study?
Beschreibung

Serious Adverse Event, Concomitant Agent, Prior Medication Usage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826257
Start Date
Beschreibung

Serious Adverse Event, Concomitant Agent, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
Stop Date
Beschreibung

Serious Adverse Event, Concomitant Agent, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Ongoing Medication?
Beschreibung

Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826666
Reason for Medication
Beschreibung

Serious Adverse Event, Concomitant Agent, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Details of Investigational Product(s)
Beschreibung

Details of Investigational Product(s)

Alias
UMLS CUI-1
C0013230
Part 1 - Investigational Product
Beschreibung

Experimental Drug

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Treatment Period
Beschreibung

Therapeutic Procedure, Period

Datentyp

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1948053
Treatment Group (A, B or C)
Beschreibung

Therapeutic Procedure, Groups

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0441833
Start Date of Dose
Beschreibung

Experimental Drug, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Part 2 - Investigational Product
Beschreibung

Experimental Drug

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Treatment Period
Beschreibung

Therapeutic Procedure, Period

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1948053
Start Date
Beschreibung

Experimental Drug, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Beschreibung

Experimental Drug, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Details of Relevant Assessments
Beschreibung

Details of Relevant Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
Provide details of any other tests/procedures which were carried out to diagnose or onfirm the SAE e.g., laboratory data with units and normal range
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
Narrative Remarks
Beschreibung

Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Narrative Remarks
Beschreibung

Serious Adverse Event, Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator's confirmation
Beschreibung

Investigator's confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0008961
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Investigator Signature, Date in time

Datentyp

date

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

Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Serious Adverse Event Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Identifier, Hospitals
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomization, Numbers
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
Serious Adverse Event, During, Clinical Trials
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event, Diagnosis, Signs and Symptoms
Item
Event
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome
Code List
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
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[X] Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
integer
C1519255 (UMLS CUI [1,1])
C1704758 (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
[1] Investigational product(s) withdrawn (1)
CL Item
[2] Dose reduced (2)
CL Item
[3] Dose increased (3)
CL Item
[4] Dose not changed (4)
CL Item
[5] Dose interrupted (5)
CL Item
[X] Not applicable (6)
Serious Adverse Event, Withdrawal by Subject
Item
Withdrawal - Did the subject withdraw from study as a result of this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Investigational New Drugs
Item
Relationship to Investigational Product(s)) - Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Serious Adverse Event, Fatal, Autopsy
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
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
Code List
Seriousness (specify reason(s) for considering this a SAE, mark all that apply)
CL Item
[A] result in death (1)
CL Item
[B] Is life-threatening (2)
CL Item
[C] Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
[D] Results in disability/incapacity (4)
CL Item
[E] Congenital anomaly/birth defect (5)
CL Item
[F] other, specify___________________________________ (6)
Item Group
Demography Data
C1519255 (UMLS CUI-1)
C1704791 (UMLS CUI-2)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Item
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Code List
If investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Possible Causes
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
Item
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
Code List
Possible causes of SAE Other Than Investigational Product(s), mark all that apply:
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify_____________________(record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify_________________(record in section 8) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify_________________________________________________ (7)
Item Group
Relevant Medical Conditions
C0012634 (UMLS CUI-1)
Medical History; Hypersensitivity; Operative Surgical Procedures
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Disease, Date of Onset
Item
Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Disease, During, Serious Adverse Event
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Disease, Occurrence, Date in time
Item
If NO, Date of Last Occurrence
date
C0012634 (UMLS CUI [1,1])
CC2745955 (UMLS CUI [1,2])
Item Group
Other Relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Serious Adverse Event, Risk Factors, Medical History, Family History
Item
Provide any family or 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])
C0262926 (UMLS CUI [1,3])
C0241889 (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 Name
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 of Measure
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (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, Prior Medication Usage
Item
Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826257 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Indication
Item
Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Details of Investigational Product(s)
C0013230 (UMLS CUI-1)
Item
Part 1 - Investigational Product
text
C0304229 (UMLS CUI [1])
Experimental Drug
Code List
Part 1 - Investigational Product
CL Item
Dutasteride (Dutasteride)
Item
Treatment Period
integer
C0087111 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Therapeutic Procedure, Period
Code List
Treatment Period
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Therapeutic Procedure, Groups
Item
Treatment Group (A, B or C)
text
C0087111 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Experimental Drug, Start Date
Item
Start Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Part 2 - Investigational Product
text
C0304229 (UMLS CUI [1])
Experimental Drug
Code List
Part 2 - Investigational Product
CL Item
Lupron (Lupron)
CL Item
Testosterone (Testosterone)
CL Item
Dutasteride (loading) (Dutasteride (loading))
CL Item
Dutasteride (Dutasteride)
CL Item
Testosterone (Testosterone)
CL Item
Dutasteride (repeat dose) (Dutasteride (repeat dose))
Therapeutic Procedure, Period
Item
Treatment Period
text
C0087111 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Experimental Drug, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Experimental Drug, End Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Details of Relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Serious Adverse Event, Evaluation
Item
Provide details of any other tests/procedures which were carried out to diagnose or onfirm the SAE e.g., laboratory data with units and normal range
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Narrative Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator's confirmation
C0750484 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
Investigator signature
Item
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
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