ID

41098

Beskrivning

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Nyckelord

Versioner (2)
  1. 2020-06-22 2020-06-22 -
  2. 2020-06-23 2020-06-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 juni 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

Engelsk

Serious Adverse Event; Serious Adverse Event (SAE) - Additional/ Follow-Up Information

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

text

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

Randomisation Number

Datatyp

text

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

Serious Adverse Event

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

If Yes, record details below.

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event (SAE) - Section 1
Beskrivning

Serious Adverse Event (SAE) - Section 1

Alias
UMLS CUI-1
C1519255
Event
Beskrivning

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatyp

text

Alias
UMLS CUI [1]
C1519255
SAE Start Date
Beskrivning

SAE Start Date

Datatyp

date

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

SAE Start Time

Datatyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
SAE Outcome
Beskrivning

SAE Outcome

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
SAE Maximum Intensity
Beskrivning

SAE Maximum Intensity

Datatyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the SAE
Beskrivning

Action Taken with Investigational Product(s) as a Result of the SAE

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

Did the subject withdraw from study as a result of this SAE?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Beskrivning

Is there a reasonable possibility the SAE may have been caused by the investigational product?

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Serious Adverse Event (SAE) - Section 2 (Seriousness)
Beskrivning

Serious Adverse Event (SAE) - Section 2 (Seriousness)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Specify reason(s) for considering this a SAE
Beskrivning

(, check all that apply:

Datatyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
If other reason for considering this a SAE, specify
Beskrivning

If other reason for considering this a SAE, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Serious Adverse Event (SAE) - Section 3 (Demography Data)
Beskrivning

Serious Adverse Event (SAE) - Section 3 (Demography Data)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0011298
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Serious Adverse Event (SAE) - Section 4 (If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?)
Beskrivning

Serious Adverse Event (SAE) - 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
C1519255
UMLS CUI-2
C0034897
UMLS CUI-3
C0304229
UMLS CUI-4
C0457454
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0457454
Serious Adverse Event (SAE) - Section 5 (Possible Causes of SAE Other Than Investigational Product(s))
Beskrivning

Serious Adverse Event (SAE) - Section 5 (Possible Causes of SAE Other Than Investigational Product(s))

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
UMLS CUI-3
C0304229
UMLS CUI-4
C0205394
Possible Causes of SAE Other Than Investigational Product(s)
Beskrivning

Check all that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0205394
If other cause of SAE, specify
Beskrivning

If other cause of SAE, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Serious Adverse Event (SAE) - Section 6 (Relevant Medical Conditions)
Beskrivning

Serious Adverse Event (SAE) - Section 6 (Relevant Medical Conditions)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
UMLS CUI-3
C0262926
Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE
Beskrivning

Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Medical Condition - Date of Onset
Beskrivning

Medical Condition - Date of Onset

Datatyp

date

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

Condition Present at Time of the SAE?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If Condition was not present at Time of the SEA, enter Date of Last Occurence
Beskrivning

If Condition was not present at Time of the SEA, enter Date of Last Occurence

Datatyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1519255
Serious Adverse Event (SAE) - Section 7 (Other relevant Risk Factors)
Beskrivning

Serious Adverse Event (SAE) - Section 7 (Other relevant Risk Factors)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0035648
UMLS CUI-3
C0205394
Other Relevant Risk Factors
Beskrivning

Other Relevant Risk Factors

Datatyp

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0205394
Serious Adverse Event (SAE) - Section 8 (Relevant Concomitant Medications)
Beskrivning

Serious Adverse Event (SAE) - Section 8 (Relevant Concomitant Medications)

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

(Trade Name preferred)

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Medication Dose
Beskrivning

Medication Dose

Datatyp

float

Alias
UMLS CUI [1]
C3174092
Medication Frequency
Beskrivning

Medication Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beskrivning

Medication Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Medication taken prior to study?
Beskrivning

Medication taken prior to study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
Medication Start Date
Beskrivning

Medication Start Date

Datatyp

date

Alias
UMLS CUI [1]
C2826734
Medication Stop Date
Beskrivning

Medication Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Beskrivning

Ongoing Medication?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

Alias
UMLS CUI [1]
C2826696
Serious Adverse Event (SAE) - Section 9 (Details of Investigational Product(s))
Beskrivning

Serious Adverse Event (SAE) - Section 9 (Details of Investigational Product(s))

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
UMLS CUI-3
C1522508
Investigational Product
Beskrivning

Investigational Product

Datatyp

text

Alias
UMLS CUI [1]
C0304229
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
Dose
Beskrivning

Dose

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3174092
Was treatment blind broken at investigational site?
Beskrivning

Was treatment blind broken at investigational site?

Alias
UMLS CUI-1
C3897431
Was treatment blind broken at investigational site?
Beskrivning

Was treatment blind broken at investigational site?

Datatyp

text

Alias
UMLS CUI [1]
C3897431
Serious Adverse Event (SAE) - Section 10 (Details of relevant Assessments)
Beskrivning

Serious Adverse Event (SAE) - Section 10 (Details of relevant Assessments)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
UMLS CUI-3
C1522508
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
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0431080
UMLS CUI [2]
C0022885
UMLS CUI [3]
C1519795
UMLS CUI [4]
C0086715
Serious Adverse Event (SAE) - Section 11 (Narrative Remarks)
Beskrivning

Serious Adverse Event (SAE) - Section 11 (Narrative Remarks)

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

Narrative Remarks

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Investigator’s signature
Beskrivning

Investigator’s signature

Alias
UMLS CUI-1
C2346576
Investigator’s signature
Beskrivning

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

Datatyp

text

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

Investigator’s name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Investigator’s signature Date
Beskrivning

Investigator’s signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
Beskrivning

Serious Adverse Event (SAE) - Additional/ Follow-Up Information

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
UMLS CUI-3
C1524062
UMLS CUI-4
C1533716
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
Beskrivning

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

Datatyp

text

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

(confirming that the data on this page is accurate and complete)

Datatyp

text

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

Investigator’s name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Investigator's Signature Date
Beskrivning

Investigator's Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tillbaka till toppen

Similar models

Serious Adverse Event; Serious Adverse Event (SAE) - Additional/ Follow-Up Information

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
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)
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])
Item Group
Serious Adverse Event (SAE) - Section 1
C1519255 (UMLS CUI-1)
Event
Item
Event
text
C1519255 (UMLS CUI [1])
SAE Start Date
Item
SAE Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
SAE Start Time
Item
SAE Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
SAE Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
SAE Outcome
Code List
SAE 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)
Item
SAE Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE Maximum Intensity
Code List
SAE Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (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
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
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
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
If fatal, was a post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE) - Section 2 (Seriousness)
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Specify reason(s) for considering this a SAE
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
SAE Seriousness
Code List
Specify reason(s) for considering this a SAE
CL Item
Results in death  (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
If other reason for considering this a SAE, specify
Item
If other reason for considering this a SAE, specify
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Event (SAE) - Section 3 (Demography Data)
C1519255 (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 (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE) - Section 4 (If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?)
C1519255 (UMLS CUI-1)
C0034897 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0457454 (UMLS CUI-4)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
integer
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 (1)
CL Item
No (2)
CL Item
Unknown at this time  (3)
CL Item
Not applicable (4)
Item Group
Serious Adverse Event (SAE) - Section 5 (Possible Causes of SAE Other Than Investigational Product(s))
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Possible Causes of SAE Other Than Investigational Product(s)
Code List
Possible Causes of SAE Other Than Investigational Product(s)
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)
If other cause of SAE, specify
Item
If other cause of SAE, specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Event (SAE) - Section 6 (Relevant Medical Conditions)
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE
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])
Medical Condition - Date of Onset
Item
Medical Condition - Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
If Condition was not present at Time of the SEA, enter Date of Last Occurence
Item
If Condition was not present at Time of the SEA, enter Date of Last Occurence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
Serious Adverse Event (SAE) - Section 7 (Other relevant Risk Factors)
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Other Relevant Risk Factors
Item
Other Relevant Risk Factors
text
C0035648 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE) - Section 8 (Relevant Concomitant Medications)
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Medication Dose
Item
Medication Dose
float
C3174092 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication taken prior to study?
Item
Medication taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE) - Section 9 (Details of Investigational Product(s))
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Investigational Product
Item
Investigational Product
text
C0304229 (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])
Dose
Item
Dose
text
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item Group
Was treatment blind broken at investigational site?
C3897431 (UMLS CUI-1)
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1])
Was treatment blind broken at investigational site?
Code List
Was treatment blind broken at investigational site?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event (SAE) - Section 10 (Details of relevant Assessments)
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
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
Item
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
C1519255 (UMLS CUI [1,1])
C0431080 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
C0086715 (UMLS CUI [4])
Item Group
Serious Adverse Event (SAE) - Section 11 (Narrative Remarks)
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Narrative Remarks
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1])
Item Group
Investigator’s signature
C2346576 (UMLS CUI-1)
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator’s name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Investigator’s signature Date
Item
Investigator’s signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1524062 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
Item
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
text
C1519255 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1533716 (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])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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