ID

33115

Beskrivning

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma 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: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form of SAE. It has to be filled in if the subject has experienced an SAE.

Nyckelord

Versioner (1)
  1. 2018-11-28 2018-11-28 -
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GlaxoSmithKline

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28 november 2018

DOI

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Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

Engelsk

Serious Adverse Event (SAE)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Investigator Number
Beskrivning

Investigator Number

Datatyp

text

Alias
UMLS CUI [1]
C2826689
Treatment number
Beskrivning

Treatment number

Datatyp

text

Alias
UMLS CUI [1]
C1522541
Session Number
Beskrivning

Session Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Serious Adverse Event (SAE)
Beskrivning

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse events during the study?
Beskrivning

If YES, indicate following sections. A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening c) requires hospitalization or prolongation of existing hospitalization d) results in disability/incapacity e) a congenital anomaly/birth defect f) other 1) Complete the Serious Adverse Event pages: A separate set of SAE pages should be used for each SAE. However, if at the time of initial reporting, multiple SAEs are apparent that are temporally and/or clinically related, then they can be reported on the same page. 2) Inform GlaxoSmithKline: The investigator must inform GSK of serious adverse events by fax or telephone (fax preferred) within 24 hours of becoming aware of the event.

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
SECTION 1 Demography
Beskrivning

SECTION 1 Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beskrivning

Race

Datatyp

integer

Alias
UMLS CUI [1]
C0034510
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Serious Adverse Events
Beskrivning

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Serious adverse events, Diagnosis
Beskrivning

Diagnosis only (if known) OR Serious signs / symptoms (list one per line). Enter only the diagnosis (if known); otherwise each serious sign and symptom should be entered on a separate line. If a diagnosis subsequently becomes available, then this should be entered and the signs and symptoms crossed out.

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Date of onset
Beskrivning

day month year. Record the date of onset of the first occurrence of the SAE.

Datatyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
Time of onset
Beskrivning

00:00-23:59. Record the exact time of onset of the SAE.

Datatyp

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
Maximum intensity
Beskrivning

Record the maximum intensity that occurred over the duration of the SAE. Amend the intensity if it increases.

Datatyp

text

Alias
UMLS CUI [1]
C1710066
Outcome of SAE
Beskrivning

All SAEs must be followed until the events are resolved, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Resolved", "Resolved with sequelae", or was "Fatal". 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 resolved" Also enter "Not resolved" if the SAE was ongoing at the time of death, but was not the cause of death.

Datatyp

text

Alias
UMLS CUI [1]
C1705586
Date of resolution or death
Beskrivning

day month year. Record the date of resolution or the date of death. If the event resolved with sequelae, enter the date the subject's medical condition stabilized. Leave blank if the event is "Not resolved".

Datatyp

date

Alias
UMLS CUI [1,1]
C2985918
UMLS CUI [1,2]
C1148348
Time of resolution or death
Beskrivning

00:00-23:59. Record the exact time of resolution of the SAE or the time of death.

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C1519255
UMLS CUI [2]
C1301931
Action taken with investigational product(s) as a result of the SAE
Beskrivning

Indicate only for the specific event(s) that were directly responsible for the action taken with investigational product(s)· None: lnvestigational product(s) continue(s) even though an adverse event has occurred. Dose adjusted: Dose is increased or decreased for one or more investigational product(s). Temporarily interrupted: Administration of one or more investigational product(s) was stopped temporarily but then restarted. Permanently discontinued: Administration of one or more investigational product(s) was stopped permanently and not restarted. Not applicable: Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or postdosing) or the subject died and there was no prior decision to discontinue investigational product(s).

Datatyp

text

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

Indicate only the event(s) directly responsible for the subject's withdrawal as indicated on the End of Study Record page.

Datatyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
Beskrivning

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 easonable possibility" is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence/arguments that may support "A reasonable possibility'' include, for example, a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concomitant illness, or relevant medical history, should also be considered.

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Does the AE meet the definition of serious?
Beskrivning

If you tick No, please fill in the non-serious AE form and not the SAE form! A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening c) requires hospitalization or prolongation of existing hospitalization d) results in disability/incapacity e) a congenital anomaly/birth defect f) other

Datatyp

text

Alias
UMLS CUI [1]
C1710056
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
Beskrivning

SECTION 3 Possible Causes of SAE other than Investigational Product(s)

Alias
UMLS CUI-1
C0015127
UMLS CUI-2
C1519255
Disease under study
Beskrivning

Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
Treatment failure
Beskrivning

Treatment failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162643
UMLS CUI [1,2]
C1519255
Withdrawal of investigational product(s)
Beskrivning

Withdrawal of investigational product(s)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1519255
Concomitant disorder
Beskrivning

Concomitant disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1519255
If Concomitant disorder, please specify
Beskrivning

Concomitant disorder, specify

Datatyp

text

Alias
UMLS CUI [1]
C0009488
Concomitant medication
Beskrivning

Concomitant medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519255
If Concomitant medication, please specify
Beskrivning

Concomitant medication, specify

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Activity related to study participation
Beskrivning

(e.g., procedures)

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
If Activity related to study participation, please specify
Beskrivning

Activity related to study participation, specify

Datatyp

text

Alias
UMLS CUI [1]
C2348568
Other causation
Beskrivning

Other causation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1519255
If Other, please specify
Beskrivning

Other, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0015127
SECTION 4 Seriousness of SAE
Beskrivning

SECTION 4 Seriousness of SAE

Alias
UMLS CUI-1
C1710056
Death
Beskrivning

Death

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
If fatal, was an autopsy done/to be performed?
Beskrivning

Send autopsy report when available.

Datatyp

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1518965
Life threatening
Beskrivning

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.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1517874
UMLS CUI [1,2]
C1519255
Hospitalization required or prolonged
Beskrivning

NOTE: In general, hospitalization 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 outpatient setting. Complications that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfills any other serious criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE should be considered serious. Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348993
UMLS CUI [1,2]
C1519255
Disabling or incapacitating
Beskrivning

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, diarrhea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3830477
UMLS CUI [1,2]
C1519255
Congenital anomaly
Beskrivning

Congenital anomaly

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2826727
UMLS CUI [1,2]
C1519255
Other seriousness
Beskrivning

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 hospitalization but may jeopardize 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 hospitalization, or development of drug dependency or drug abuse.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0205394
If Other, please specify
Beskrivning

Other, specify

Datatyp

text

Alias
UMLS CUI [1]
C0205394
SECTION 5 Relevant Medical Conditions
Beskrivning

SECTION 5 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.
Beskrivning

Past/Current disease, allergies, surgeries

Datatyp

text

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0012634
UMLS CUI [3]
C0020517
UMLS CUI [4]
C0543467
Date of onset
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0574845
Condition present at time of the SAE
Beskrivning

Condition present at time of the SAE

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If you tick NO in "Condition present at time of the SAE", date of last occurrence
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1519255
SECTION 6 Other Relevant Risk Factors
Beskrivning

SECTION 6 Other Relevant Risk Factors

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
Specify any family history or any social history relevant to the SAE.
Beskrivning

(e.g., smoking, alcohol, diet, drug abuse, occupational hazard)

Datatyp

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C3714536
SECTION 7 Details of Investigational Product(s)
Beskrivning

SECTION 7 Details of Investigational Product(s)

Alias
UMLS CUI-1
C0013230
UMLS CUI-2
C1522508
lnvestigational product
Beskrivning

lnvestigational product

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Treatment period
Beskrivning

Treatment period

Datatyp

integer

Alias
UMLS CUI [1]
C2347804
Date of dose
Beskrivning

Date of dose

Datatyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
SECTION 8 Relevant Concomitant Medications
Beskrivning

SECTION 8 Relevant Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug
Beskrivning

(Trade name preferred)

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Drug Dose
Beskrivning

Drug Dose

Datatyp

integer

Alias
UMLS CUI [1]
C0678766
Dose unit
Beskrivning

Dose unit

Datatyp

text

Alias
UMLS CUI [1]
C0869039
Frequency
Beskrivning

Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Date started
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Started pre-study
Beskrivning

Started pre-study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Date stopped
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Tick if continued Post-SAE
Beskrivning

Post-SAE, continuing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0032756
UMLS CUI [1,3]
C1519255
Conditions treated / indication
Beskrivning

Conditions treated / indication

Datatyp

text

Alias
UMLS CUI [1]
C2826696
SECTION 9 Narrative / Comments
Beskrivning

SECTION 9 Narrative / Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
Description of SAE
Beskrivning

This should include but not be limited to the following: • Any previous occurrences of this type of event • Any relevant non-serious adverse events that occurred prior to the SAE • The full clinical presentation and sequelae/evolution of the SAE • Any associated signs and symptoms of the SAE • Explain any possible causes of the SAE • Treatment for the SAE (including any specific medications administered or non-drug treatment) • Any other action taken for the management of the SAE or the subject • Duration and outcome of the SAE • If the SAE is associated with an overdose of investigational product(s), details of the amount of overdose and whether it was intentional or accidental.

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
SECTION 10 Details of Relevant Assessments
Beskrivning

SECTION 10 Details of Relevant Assessments

Alias
UMLS CUI-1
C1261322
UMLS CUI-2
C1519255
Details of assessment
Beskrivning

Provide details of any other assessments or supplementary investigations/examinations that were conducted as part of the subject’s care and/or based on clinical judgment of the likely causative factors of the SAE. This may include, but not be limited to: • Laboratory data. Always provide the reference range and baseline values (fax or mail pages if extensive supporting data) • Findings of ECGs, X-rays, etc. • Results of other diagnostic tests or assays • Key findings from hospital discharge or pathology reports

Datatyp

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0220825
SECTION 11 Reporting Investigator
Beskrivning

SECTION 11 Reporting Investigator

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1533716
Reporting investigator - Name (print)
Beskrivning

The reporting investigator (not the study nurse or study monitor) must sign and date the SAE page.

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Address
Beskrivning

Address

Datatyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0008961
Invetigator Signature
Beskrivning

Invetigator Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Additional or follow-up information
Beskrivning

Additional or follow-up information

Alias
UMLS CUI-1
C1533716
UMLS CUI-2
C1519255
Additional details of SAE
Beskrivning

Use this page to provide any additional details on the serious adverse event not already captured on the previous pages. The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.

Datatyp

text

Alias
UMLS CUI [1,1]
C1546922
UMLS CUI [1,2]
C1519255
Tillbaka till toppen

Similar models

Serious Adverse Event (SAE)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Investigator Number
Item
Investigator Number
text
C2826689 (UMLS CUI [1])
Treatment number
Item
Treatment number
text
C1522541 (UMLS CUI [1])
Item
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
Session 1 (1)
CL Item
Session 2 (2)
CL Item
Session 3 (3)
CL Item
Session 4 (4)
CL Item
Session 5 (5)
CL Item
Session 6 (6)
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
SAE during study
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 1 Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
Other (4)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Serious adverse events, Diagnosis
Item
Serious adverse events, Diagnosis
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time of onset
Item
Time of onset
time
C0449244 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1710066 (UMLS CUI [1])
Maximum intensity
Code List
Maximum intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Outcome of SAE
text
C1705586 (UMLS CUI [1])
Outcome of SAE
Code List
Outcome of SAE
CL Item
Resolved (R)
CL Item
Resolved with Sequelae (S)
CL Item
Fatal (F)
CL Item
Not Resolved (N)
Date of resolution or death
Item
Date of resolution or death
date
C2985918 (UMLS CUI [1,1])
C1148348 (UMLS CUI [1,2])
Time of resolution or death
Item
Time of resolution or death
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
Item
Action taken with investigational product(s) as a result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this SAE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Relationship to investigational product(s)
Code List
Is there a reasonable possibility the SAE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1])
Seriousness
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SECTION 3 Possible Causes of SAE other than Investigational Product(s)
C0015127 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Disease
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Treatment failure
Item
Treatment failure
boolean
C0162643 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Concomitant disorder
Item
Concomitant disorder
boolean
C0009488 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Concomitant disorder, specify
Item
If Concomitant disorder, please specify
text
C0009488 (UMLS CUI [1])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Concomitant medication, specify
Item
If Concomitant medication, please specify
text
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation
boolean
C2348568 (UMLS CUI [1])
Activity related to study participation, specify
Item
If Activity related to study participation, please specify
text
C2348568 (UMLS CUI [1])
Other causation
Item
Other causation
boolean
C0205394 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Other, specify
Item
If Other, please specify
text
C0205394 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item Group
SECTION 4 Seriousness of SAE
C1710056 (UMLS CUI-1)
Death
Item
Death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
If fatal, was an autopsy done/to be performed?
text
C0004398 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
Autopsy performance
Code List
If fatal, was an autopsy done/to be performed?
CL Item
Yes (Y)
CL Item
No (N)
Life threatening
Item
Life threatening
boolean
C1517874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Hospitalization required/prolonged
Item
Hospitalization required or prolonged
boolean
C2348993 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Disabling/incapacitating
Item
Disabling or incapacitating
boolean
C3830477 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other seriousness
Item
Other seriousness
boolean
C1710056 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other, specify
Item
If Other, please specify
text
C0205394 (UMLS CUI [1])
Item Group
SECTION 5 Relevant Medical Conditions
C0012634 (UMLS CUI-1)
Past/Current disease, allergies, surgeries
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C1444637 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Condition present at time of the SAE
text
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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 you tick NO in "Condition present at time of the SAE", date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
SECTION 6 Other Relevant Risk Factors
C0205394 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Any family history/any social history relevant to the SAE.
Item
Specify any family history or any social history relevant to the SAE.
text
C0241889 (UMLS CUI [1,1])
C3714536 (UMLS CUI [1,2])
Item Group
SECTION 7 Details of Investigational Product(s)
C0013230 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
lnvestigational product
Item
lnvestigational product
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Treatment period
Item
Treatment period
integer
C2347804 (UMLS CUI [1])
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
SECTION 8 Relevant Concomitant Medications
C2347852 (UMLS CUI-1)
Drug
Item
Drug
text
C0013227 (UMLS CUI [1])
Drug Dose
Item
Drug Dose
integer
C0678766 (UMLS CUI [1])
Dose unit
Item
Dose unit
text
C0869039 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Date started
Item
Date started
date
C0808070 (UMLS CUI [1])
Started pre-study
Item
Started pre-study
boolean
C0808070 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Date stopped
Item
Date stopped
date
C0806020 (UMLS CUI [1])
Post-SAE, continuing
Item
Tick if continued Post-SAE
boolean
C0549178 (UMLS CUI [1,1])
C0032756 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Conditions treated / indication
Item
Conditions treated / indication
text
C2826696 (UMLS CUI [1])
Item Group
SECTION 9 Narrative / Comments
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Description of SAE
Item
Description of SAE
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
SECTION 10 Details of Relevant Assessments
C1261322 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Details of assessment
Item
Details of assessment
text
C1522508 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Item Group
SECTION 11 Reporting Investigator
C0008961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Reporting investigator - Name
Item
Reporting investigator - Name (print)
text
C2826892 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Invetigator Signature
Item
Invetigator Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Additional or follow-up information
C1533716 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Additional details SAE
Item
Additional details of SAE
text
C1546922 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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