ID

41098

Beschreibung

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

Stichworte

Versionen (2)
  1. 22.06.20 22.06.20 -
  2. 23.06.20 23.06.20 -
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GlaxoSmithKline

Hochgeladen am

23. Juni 2020

DOI

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

Englisch

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

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

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

Randomisation Number

Datentyp

text

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

Serious Adverse Event

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

If Yes, record details below.

Datentyp

boolean

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

Serious Adverse Event (SAE) - Section 1

Alias
UMLS CUI-1
C1519255
Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1519255
SAE Start Date
Beschreibung

SAE Start Date

Datentyp

date

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

SAE Start Time

Datentyp

time

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

SAE Outcome

Datentyp

integer

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

SAE Maximum Intensity

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

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?
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

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

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

(, check all that apply:

Datentyp

text

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

If other reason for considering this a SAE, specify

Datentyp

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)
Beschreibung

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

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • 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?)
Beschreibung

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?
Beschreibung

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

Datentyp

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))
Beschreibung

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)
Beschreibung

Check all that apply

Datentyp

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
Beschreibung

If other cause of SAE, specify

Datentyp

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)
Beschreibung

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
Beschreibung

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

Datentyp

text

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

Medical Condition - Date of Onset

Datentyp

date

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

Condition Present at Time of the SAE?

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

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
Beschreibung

Other Relevant Risk Factors

Datentyp

text

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

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

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

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Medication Dose
Beschreibung

Medication Dose

Datentyp

float

Alias
UMLS CUI [1]
C3174092
Medication Frequency
Beschreibung

Medication Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Beschreibung

Medication Route

Datentyp

text

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

Medication taken prior to study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication Stop Date
Beschreibung

Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

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

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
Beschreibung

Investigational Product

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beschreibung

Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Dose
Beschreibung

Dose

Datentyp

text

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

Was treatment blind broken at investigational site?

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

Was treatment blind broken at investigational site?

Datentyp

text

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

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
Beschreibung

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

Datentyp

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)
Beschreibung

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

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

Narrative Remarks

Datentyp

text

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

Investigator’s signature

Alias
UMLS CUI-1
C2346576
Investigator’s signature
Beschreibung

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

Datentyp

text

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

Investigator’s name

Datentyp

text

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

Investigator’s signature Date

Datentyp

date

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

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

text

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

Investigator’s name

Datentyp

text

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

Investigator's Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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