ID

40845

Description

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects 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: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Serious adverse event (SAE) Form has to be filled in whenever such events occur during the study.

Keywords

Versions (1)
  1. 5/24/20 5/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 24, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

English

Serious Adverse Event (SAE)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Randomisation Number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Description

Visit Type

Data type

text

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

Serious Adverse Event

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

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.

Data type

boolean

Alias
UMLS CUI [1]
C1519255
If fatal, was a post-mortem/autopsy performed?
Description

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

Data type

boolean

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

SECTION 1

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

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.

Data type

text

Alias
UMLS CUI [1]
C0011900
Start Date
Description

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

Data type

date

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

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

Data type

time

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

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.

Data type

integer

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

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’.

Data type

date

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

Record the end time of the SAE.

Data type

time

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

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).

Data type

text

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

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = 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).

Data type

text

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

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.

Data type

boolean

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?
Description

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.

Data type

boolean

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

SECTION 2: Seriousness

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

SAE results in death

Data type

boolean

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

SAE is life-threatening

Data type

boolean

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

SAE requires hospitalisation

Data type

boolean

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

SAE results in disability/incapacity

Data type

boolean

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

SAE: Congenital anomaly/birth defect

Data type

boolean

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

SAE, other

Data type

boolean

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

(see definition of SAE)

Data type

text

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

SECTION 3 Demography Data

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

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Data type

float

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

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?
Description

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

Data type

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)
Description

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
Description

Disease under study

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Medical condition(s)
Description

(record in Section 6)

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Lack of efficacy
Description

Lack of efficacy

Data type

boolean

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

Withdrawal of investigational product(s)

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
Concomitant medication(s)
Description

(record in Section 8)

Data type

boolean

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

Activity related to study participation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Other, specify
Description

Other, specify

Data type

text

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

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
Description

Relevant Medical Conditions

Data type

text

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

Date of onset

Data type

date

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

Condition Present at Time of the SAE?

Data type

boolean

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

Date of Last Occurrence

Data type

date

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

SECTION 7 Other RELEVANT Risk Factors

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

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

Data type

text

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

SECTION 8 RELEVANT Concomitant Medications

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

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Dose
Description

Dose

Data type

float

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

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

Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

Ongoing Medication?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SECTION 9 Details of Investigational Product(s) - Treatment Period 1
Description

SECTION 9 Details of Investigational Product(s) - Treatment Period 1

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0013230
UMLS CUI-3
C1522508
Infusion Start Date
Description

Infusion Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0439659
Infusion Start Time
Description

Infusion Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0040223
Infusion Stop Date
Description

Infusion Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
Infusion Stop Time
Description

Infusion Stop Time

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
IV Dose [14C]-GW679769 Administered
Description

IV Administration Casopitant Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1522726
UMLS CUI [1,2]
C2347566
UMLS CUI [1,3]
C3174092
mg
SECTION 9 Details of Investigational Product(s) - Treatment Period 2
Description

SECTION 9 Details of Investigational Product(s) - Treatment Period 2

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0013230
UMLS CUI-3
C1522508
Date of Dose
Description

Date of Dose

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Description

Time of Dose

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Oral Dose [14C]-GW679769 Administered
Description

Oral Administration Casopitant Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C1527415
UMLS CUI [1,2]
C2347566
UMLS CUI [1,3]
C3174092
mg
SECTION 10 Details of relevant Assessments
Description

SECTION 10 Details of relevant Assessments

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011900
UMLS CUI-3
C1519255
Details of RELEVANT Assessments
Description

(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)

Data type

text

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

SECTION 11 Narrative Remarks

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0947611
Narrative Remarks
Description

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

Data type

text

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

Investigator's name and signature

Alias
UMLS CUI-1
C2826892
UMLS CUI-3
C2346576
Investigator's signature
Description

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

Data type

text

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

(print)

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
SECTION 12: Additional/Follow-Up Information
Description

SECTION 12: Additional/Follow-Up Information

Alias
UMLS CUI-1
C1524062
UMLS CUI-2
C1533716
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
SAE Additional/Follow-up Information
Description

use this page to provide any additional details on the SAE not already captured on the previous pages

Data type

text

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1522577
Investigator's Signature
Description

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

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's name
Description

print

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Event (SAE)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit Type
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Autopsy after serious event
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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)
(Comment:en)
CL Item
Dose reduced (2)
(Comment:en)
CL Item
Dose increased (3)
(Comment:en)
CL Item
Dose not changed (4)
(Comment:en)
CL Item
Dose interrupted (5)
(Comment:en)
CL Item
Not applicable (X)
(Comment:en)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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)
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)
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])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
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])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
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) - Treatment Period 1
C1828479 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Infusion Start Date
Item
Infusion Start Date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start Time
Item
Infusion Start Time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop Date
Item
Infusion Stop Date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop Time
Item
Infusion Stop Time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
IV Administration Casopitant Dose
Item
IV Dose [14C]-GW679769 Administered
float
C1522726 (UMLS CUI [1,1])
C2347566 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Item Group
SECTION 9 Details of Investigational Product(s) - Treatment Period 2
C1828479 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Oral Administration Casopitant Dose
Item
Oral Dose [14C]-GW679769 Administered
float
C1527415 (UMLS CUI [1,1])
C2347566 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
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
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
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
text
C2346576 (UMLS CUI [1])
Investigator’s name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
SECTION 12: Additional/Follow-Up Information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
SAE Additional/Follow-up Information
Item
SAE Additional/Follow-up Information
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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