ID

32401

Descrição

This ODM file contains the form to document all serious events that are temporally associated with the use of the study medication. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

Palavras-chave

Versões (2)
  1. 28/10/2018 28/10/2018 -
  2. 30/10/2018 30/10/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

30 de outubro de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880

Inglês

Serious Adverse Event

1 Formulários  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrição

Centre Number

Tipo de dados

text

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

Randomisation Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Serious Adverse Event
Descrição

Serious Adverse Event

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

DEFINITION OF A SERIOUS ADVERSE EVENT (SAE) (Page 1 of 5) A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. Note: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c) requires hospitalisation or prolongation of existing hospitalisation. Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or Note: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) is a congenital anomaly/birth defect. f) other. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.

Tipo de dados

text

Alias
UMLS CUI [1]
C1519255
If fatal, was a post-mortem/autopsy performed If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
SECTION 1
Descrição

SECTION 1

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1519255
Diagnosis Only (if known) Otherwise Sign/Symptom
Descrição

Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.

Tipo de dados

text

Alias
UMLS CUI [1]
C0011900
Start Date
Descrição

Record the start date of the first occurrence of the SAE.

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Start Time
Descrição

Record the start date of the first occurrence of the SAE.

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1519255
Outcome
Descrição

All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.

Tipo de dados

integer

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

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

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
End Time
Descrição

Record the end time of the SAE.

Tipo de dados

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Maximum Intensity
Descrição

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Actions taken with Investigational Product(s) as a Result of the SAE
Descrição

Investigational product(s) withdrawn = Dose reduced = Dose increased = Dose not changed = Dose interrupted = Not applicable = Administration of investigational product(s) was permanently discontinued. Dose is reduced for one or more investigational product(s). Dose increased for one or more investigational product(s). Investigational product(s) continues even though an adverse event has occurred. Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
Descrição

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If yes: Complete Study Conclusion page and check Adverse event as reason for withdrawal.

Tipo de dados

text

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

It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
SECTION 2: Seriousness
Descrição

SECTION 2: Seriousness

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1710056
[A] Results in death
Descrição

SAE results in death

Tipo de dados

boolean

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

SAE is life-threatening

Tipo de dados

boolean

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

SAE requires hospitalisation

Tipo de dados

boolean

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

SAE results in disability/incapacity

Tipo de dados

boolean

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

SAE: Congenital anomaly/birth defect

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
[F] Other
Descrição

SAE, other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
Other, specify
Descrição

(see definition of SAE)

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3845569
UMLS CUI [1,2]
C1519255
SECTION 3 Demography Data
Descrição

SECTION 3 Demography Data

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011298
Date of birth
Descrição

Date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrição

Sex

Tipo de dados

text

Alias
UMLS CUI [1]
C0079399
Weight
Descrição

Weight

Tipo de dados

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Descrição

SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0034897
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Descrição

Recurrence of the reported SAE in case of discontinuation of the investigational product

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0457454
SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
Descrição

SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0085978
UMLS CUI-3
C1710056
Disease under study
Descrição

Disease under study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Medical condition(s) (record in Section 6)
Descrição

Medical condition(s)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012634
Lack of efficacy
Descrição

Lack of efficacy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235828
Withdrawal of investigational product(s)
Descrição

Withdrawal of investigational product(s)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant medication(s) (record in Section 8)
Descrição

Concomitant medication(s)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
Activity related to study participation (e.g., procedures)
Descrição

Activity related to study participation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify
Descrição

Other, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
SECTION 6 RELEVANT Medical Conditions
Descrição

SECTION 6 RELEVANT Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C1828479
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Descrição

Relevant Medical Conditions

Tipo de dados

text

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

Date of onset

Tipo de dados

date

Alias
UMLS CUI [1]
C0574845
Condition Present at Time of the SAE?
Descrição

Condition Present at Time of the SAE?

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0521116
If No, Date of Last Occurrence
Descrição

Date of Last Occurrence

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2745955
SECTION 7 Other RELEVANT Risk Factors
Descrição

SECTION 7 Other RELEVANT Risk Factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C1519255
UMLS CUI-3
C0205394
Other RELEVANT Risk Factors
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C0035648
SECTION 8 RELEVANT Concomitant Medications
Descrição

SECTION 8 RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C2347852
Drug Name
Descrição

(Trade Name preferred)

Tipo de dados

text

Alias
UMLS CUI [1]
C0013227
Dose
Descrição

Dose

Tipo de dados

float

Alias
UMLS CUI [1]
C3174092
Unit
Descrição

Unit

Tipo de dados

text

Alias
UMLS CUI [1]
C1519795
Frequency
Descrição

Frequency

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Route
Descrição

Route

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Descrição

Taken Prior to Study?

Tipo de dados

text

Alias
UMLS CUI [1]
C2826667
Start Date
Descrição

Start Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Descrição

Stop Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Descrição

Ongoing Medication?

Tipo de dados

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Descrição

Reason for Medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SECTION 9 Details of Investigational Product(s)
Descrição

SECTION 9 Details of Investigational Product(s)

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0013230
UMLS CUI-3
C1522508
Period
Descrição

Study Period

Tipo de dados

integer

Alias
UMLS CUI [1]
C2347804
Treatment Type
Descrição

Treatment A = Dutasteride 0.5mg Softgel capsule (Reference) Treatment B = Dutasteride 0.5mg Softgel capsule containing 300mg Capmul Treatment C = Dutasteride 0.5mg Softgel capsule containing 100mg Capmul

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0304229
Dose
Descrição

Study Medication Dose

Tipo de dados

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Date of Dose
Descrição

Date of Dose

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Time of Dose
Descrição

Time of Dose

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
SECTION 10 Details of relevant Assessments
Descrição

SECTION 10 Details of relevant Assessments

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011900
UMLS CUI-3
C1519255
Details of RELEVANT Assessments (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)
Descrição

Details of relevant assessments

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
SECTION 11 Narrative Remarks
Descrição

SECTION 11 Narrative Remarks

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0947611
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Descrição

Narrative Remarks

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator's name and signature
Descrição

Investigator's name and signature

Alias
UMLS CUI-1
C2826892
UMLS CUI-3
C2346576
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
Descrição

Investigator's signature

Tipo de dados

text

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

Investigator’s name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Date
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Event

1 Formulários
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
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
Serious Adverse Event
C1519255 (UMLS CUI-1)
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
Did the subject experience a serious adverse event during the study?
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If fatal, was a post-mortem/autopsy performed If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
text
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Autopsy after serious event
Code List
If fatal, was a post-mortem/autopsy performed If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 1
C1828479 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Event
Item
Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1])
Start Date of the Serious Adverse Event
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start Time of Serious Adverse Event
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (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)
End Date of Serious Adverse Event
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Time of Serious Adverse Event
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Actions taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Actions taken with Investigational Product(s) as a Result of the SAE
Code List
Actions taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Doce increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
text
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this SAE?
Code List
Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
CL Item
No (N)
CL Item
Yes (Y)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Code List
Is there a reasonable possibility the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 2: Seriousness
C1828479 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
SAE results in death
Item
[A] Results in death
boolean
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE is life-threatening
Item
[B] Is life-threatening
boolean
C1517874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C2826664 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE: Congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE, other
Item
[F] Other
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
SAE, other: specification
Item
Other, specify
text
C3845569 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 3 Demography Data
C1828479 (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
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
C0877248 (UMLS CUI-1)
C0034897 (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])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
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 (Yes)
CL Item
No (No)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
C1828479 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C1710056 (UMLS CUI-3)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Medical condition(s)
Item
Medical condition(s) (record in Section 6)
boolean
C0012634 (UMLS CUI [1])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant medication(s)
Item
Concomitant medication(s) (record in Section 8)
boolean
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation (e.g., procedures)
boolean
C2348568 (UMLS CUI [1])
Other, specify
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
SECTION 6 RELEVANT Medical Conditions
C0262926 (UMLS CUI-1)
C1828479 (UMLS CUI-2)
Relevant Medical Conditions
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
C1519255 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Condition Present at Time of the SAE
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C0011008 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Item Group
SECTION 7 Other RELEVANT Risk Factors
C0035648 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
Item Group
SECTION 8 RELEVANT Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
Taken Prior to Study?
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
Ongoing Medication?
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
SECTION 9 Details of Investigational Product(s)
C1828479 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Item
Period
integer
C2347804 (UMLS CUI [1])
Study Period
Code List
Period
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Treatment Type
text
C1276413 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Treatment Type
Code List
Treatment Type
CL Item
Treatment A (Treatment A)
CL Item
Treatment B (Treatment B)
CL Item
Treatment C (Treatment C)
Study Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
SECTION 10 Details of relevant Assessments
C1828479 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Details of relevant assessments
Item
Details of RELEVANT Assessments (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)
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 11 Narrative Remarks
C1828479 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Narrative Remarks
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Investigator's name and signature
C2826892 (UMLS CUI-1)
C2346576 (UMLS CUI-3)
Investigator's signature
Item
Investigator's signature (confirming that the data on the SAE pages are accurate and complete)
text
C2346576 (UMLS CUI [1])
Investigator’s name
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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