ID

32856

Descripción

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

Palabras clave

Versiones (4)
  1. 19/10/18 19/10/18 -
  2. 16/11/18 16/11/18 -
  3. 19/1/19 19/1/19 -
  4. 4/3/19 4/3/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Inglés

Serious Adverse Event Form

1 formularios  
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Descripción

Identifier, Hospitals

Tipo de datos

integer

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

Randomization, Numbers

Tipo de datos

integer

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

Serious Adverse Event (SAE)

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

Serious Adverse Event, During, Clinical Trials

Tipo de datos

boolean

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

Serious Adverse Event, Diagnosis, Signs and Symptoms

Tipo de datos

text

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

Serious Adverse Event, Start Date

Tipo de datos

date

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

Serious Adverse Event, Adverse Event Outcome

Tipo de datos

integer

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

Serious Adverse Event, End Date

Tipo de datos

date

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

Serious Adverse Event, Seriousness of Adverse Event

Tipo de datos

integer

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

Serious Adverse Event, Action Taken with Study Treatment

Tipo de datos

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?
Descripción

Serious Adverse Event, Withdrawal by Subject

Tipo de datos

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?
Descripción

Serious Adverse Event, Relationships, Investigational New Drugs

Tipo de datos

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?
Descripción

Serious Adverse Event, Fatal, Autopsy

Tipo de datos

boolean

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

Seriousness

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

Serious Adverse vent, Seriousness of Adverse Event

Tipo de datos

text

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

Demography Data

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

Patient date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Gender

Tipo de datos

integer

Alias
UMLS CUI [1]
C0079399
Weight
Descripción

Body Weight

Tipo de datos

float

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

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?
Descripción

Serious Adverse Event, Experimental Drug

Tipo de datos

text

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

Possible Causes

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

Serious Adverse Event, Causations

Tipo de datos

text

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

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
Descripción

Medical History; Hypersensitivity; Operative Surgical Procedures

Tipo de datos

text

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

Disease, Date of Onset

Tipo de datos

date

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

Disease, During, Serious Adverse Event

Tipo de datos

boolean

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

Disease, Occurrence, Date in time

Tipo de datos

date

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

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
Descripción

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

Tipo de datos

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
Descripción

Relevant Concomitant Medications

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

Serious Adverse Event, Concomitant Agent, Medication Name

Tipo de datos

text

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

Serious Adverse Event, Concomitant Agent, Medication Dose

Tipo de datos

integer

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

Serious Adverse Event, Concomitant Agent, Unit of Measure

Tipo de datos

text

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

Serious Adverse Event, Concomitant Agent,, Frequencies

Tipo de datos

text

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

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Tipo de datos

text

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

Serious Adverse Event, Concomitant Agent, Prior Medication Usage

Tipo de datos

boolean

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

Serious Adverse Event, Concomitant Agent, Start Date

Tipo de datos

date

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

Serious Adverse Event, Concomitant Agent, End Date

Tipo de datos

date

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

Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing

Tipo de datos

boolean

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

Serious Adverse Event, Concomitant Agent, Indication

Tipo de datos

text

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

Details of Investigational Product(s)

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

Experimental Drug

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Treatment Period
Descripción

Therapeutic Procedure, Period

Tipo de datos

integer

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

Therapeutic Procedure, Groups

Tipo de datos

text

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

Experimental Drug, Start Date

Tipo de datos

date

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

Experimental Drug

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Treatment Period
Descripción

Therapeutic Procedure, Period

Tipo de datos

text

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

Experimental Drug, Start Date

Tipo de datos

date

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

Experimental Drug, End Date

Tipo de datos

date

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

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
Descripción

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

Tipo de datos

text

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

Narrative Remarks

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

Serious Adverse Event, Comment

Tipo de datos

text

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

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)
Descripción

Investigator signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

Investigator Signature, Date in time

Tipo de datos

date

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

Investigator Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Volver a la parte superior de la página

Similar models

Serious Adverse Event Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial