ID

32361

Descripción

Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Palabras clave

Versiones (1)
  1. 27/10/18 27/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

27 de octubre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125

Inglés

Logs/ Repeats, Non- Serious Adverse Event, Serious Adverse Event, Concomitant Medication, Electronically Transferred Lab Data, Vital Signs, ECG, Repeat Pharmacodynamics - Cortisol, Glucose, Potassium, FF/GWG642444M, Defective Inhaler, X Ray Pneumonia Confirmation

1 formularios  
Logs and Repeats - Date of Visit/ Assessment
Descripción

Logs and Repeats - Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Descripción

Date of Visit/ Assessment

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions
Descripción

Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C1516048
Were any concomitant medications taken by the study subject during the study?
Descripción

Concomitant Medications

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non- serious adverse events during the study?
Descripción

Non- serious Adverse Events

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Descripción

Serious Adverse Events

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Were any repeat hematology, urinalysis or clinical chemistry samples taken?
Descripción

Hematology, Urinalysis or Clinical Chemistry Samples taken

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018943
UMLS CUI [1,2]
C1277698
UMLS CUI [2,1]
C0042014
UMLS CUI [2,2]
C1277698
UMLS CUI [3,1]
C0008000
UMLS CUI [3,2]
C1277698
Were any repeat vital signs recorded?
Descripción

Vital Signs recorded

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518766
Were any repeat Cortisol pharmacodynamic samples taken?
Descripción

Cortisol pharmacodynamic samples taken

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201968
UMLS CUI [1,2]
C0851347
UMLS CUI [1,3]
C1277698
Were any repeat Glucose pharmacodynamic samples taken?
Descripción

Glucose pharmacodynamic samples

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017725
UMLS CUI [1,2]
C0851347
UMLS CUI [1,3]
C1277698
Were any repeat Potassium pharmacodynamic samples taken?
Descripción

Potassium pharmacodynamic samples

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032821
UMLS CUI [1,2]
C0851347
UMLS CUI [1,3]
C1277698
Were any repeat pharmacokinetic samples taken?
Descripción

Pharmacokinetic samples

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1277698
Did the subject experience any Investigational Product Device Malfunctions?
Descripción

undefined item

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0086138
Were any chest x- rays taken for suspected Pneumonia?
Descripción

X- rays taken for suspected Pneumonia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0277540
UMLS CUI [1,3]
C0032285
Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
Descripción

Liver chemistry results reached or exceeded stopping criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1254595
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C2746065
Non- serious Adverse Event
Descripción

Non- serious Adverse Event

Alias
UMLS CUI-1
C1518404
Sequence Number
Descripción

Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Event (Diagnosis only (if known), otherwise Sign/ Symptom
Descripción

Event (Diagnosis only (if known), otherwise Sign/ Symptom

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
UMLS CUI [2]
C0037088
Non Serious Adverse Event Start Date and Time
Descripción

Non Serious Adverse Event Start Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826806
Non- Serious Adverse Event End Date and Time
Descripción

Non- Serious Adverse Event End Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826793
Non- Serious Adverse Event Outcome
Descripción

Non- Serious Adverse Event Outcome

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non- Serious Adverse Event Frequency
Descripción

Non- Serious Adverse Event Frequency

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non- Serious Adverse Event Maximum Intensity
Descripción

Non- Serious Adverse Event Maximum Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Non- serious Adverse Event Maximum Grade
Descripción

Maximum Grade of Non- serious Adverse Event

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2985911
UMLS CUI [1,2]
C0806909
Non- serious Adverse Event Maximum Grade or Intensity
Descripción

Non- serious Adverse Event Maximum Grade or Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
Action taken with Investigational Product(s) as a Result of the AE
Descripción

Action taken with Investigational Product(s) as a Result of the AE

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

AE may have been caused by the investigational product?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Duration of AE if < 24 hours
Descripción

Duration of AE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Descripción

Time to Onset Since Last Dose

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
Serious Adverse Event
Descripción

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Serious Adverse Event Initial Report
Descripción

Serious Adverse Event Initial Report

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0205265
Serious Adverse Event Follow- up Report
Descripción

Follow- up Report

Tipo de datos

integer

Alias
UMLS CUI [1]
C1704685
Did SAE occur after initiation of study medication?
Descripción

Did SAE occur after initiation of study medication?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1704686
SAE Sequence Number
Descripción

SAE Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event
Descripción

Diagnosis only (if known), otherwise Sign/ Symptom.

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Modified term
Descripción

Serious Adverse Event Modified term

Tipo de datos

text

Alias
UMLS CUI [1]
C2826798
Serious Adverse Event MedDRA synoym
Descripción

MedDRA synoym

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1552878
Serious Adverse Event MedDRA lower level code
Descripción

Serious Adverse Event MedDRA lower level code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
Serious Adverse Event Start Date and Time
Descripción

Serious Adverse Event Start Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826806
Serious Adverse Event Outcome
Descripción

Serious Adverse Event Outcome

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event End Date and Time / Date and Time of Death
Descripción

Serious Adverse Event End Date and Time / Date and Time of Death

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826793
UMLS CUI [2]
C3899439
Serious Adverse Event Maximum Intensity
Descripción

Serious Adverse Event Maximum Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Action taken with Investigational Product(s) as a Result of the AE integer
Descripción

Action taken with Investigational Product(s) as a Result of the AE

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

AE may have been caused by the investigational product?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Was SAE caused by activities related to study participation (e.g. procedure)?
Descripción

Was SAE caused by activities related to study participation?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439849
Was the event serious?
Descripción

Was the event serious?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Seriousness of Adverse Event
Descripción

Seriousness of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C1710056
Relevant medical conditions/ risk factors
Descripción

Relevant medical conditions/ risk factors

Alias
UMLS CUI-1
C0012634
UMLS CUI-3
C0035648
MHx Sequence Number
Descripción

MHx Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Specific Condition Name
Descripción

Specific Condition Name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Medical Conditions Date of onset
Descripción

Medical Conditions Date of onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0574845
Is medical condition continuing?
Descripción

Is medical condition continuing?

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
If medical condition is not continuing, specify date of last occurence.
Descripción

Medical condition date of last occurence

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C1517741
Relevant Medical History / Risk Factors not noted above
Descripción

Relevant Medical History / Risk Factors not noted above

Tipo de datos

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0035648
Relevant Concomitant/ Treatment Medications
Descripción

Relevant Concomitant/ Treatment Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
CM Sequence Number
Descripción

CM Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Drug Name (Trade Name preferred)
Descripción

Drug Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Medication Dose
Descripción

Medication Dose

Tipo de datos

float

Alias
UMLS CUI [1]
C3174092
Medication Dose Unit
Descripción

Medication Dose Unit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0439148
Medication Frequency
Descripción

Medication Frequency

Tipo de datos

integer

Alias
UMLS CUI [1]
C3476109
Medication route
Descripción

Medication route

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013153
Medication Start Date
Descripción

Medication Start Date

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826734
Is Concomitant Medication ongoing?
Descripción

Is Concomitant Medication ongoing?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
If Concomitant Medication is not ongoing, sepcify End Date
Descripción

If Concomitant Medication is not ongoing, sepcify End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0806020
Primary Indication for concomitant/ treatment medications
Descripción

Primary Indication for concomitant/ treatment medications

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C2347852
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0013227
Drug type
Descripción

Drug type

Tipo de datos

integer

Alias
UMLS CUI [1]
C0457591
Relevant Diagnostic Results
Descripción

Relevant Diagnostic Results

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
Lab Sequence Number
Descripción

Lab Sequence Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0022877
Test Name
Descripción

Test Name

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826273
Test Date
Descripción

Test Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826247
Test Result
Descripción

Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C0456984
Test Units
Descripción

Test Units

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
Normal Low Range
Descripción

Normal Low Range

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal High Range
Descripción

Normal High Range

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Descripción

Relevant diagnostic results not noted above

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
Investigational Product
Descripción

Investigational Product

Alias
UMLS CUI-1
C0304229
If investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Descripción

Did the reported event(s) recur after further investigational product(s) were administered?

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0034897
General Narrative Comments
Descripción

General Narrative Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1135957
General Narrative Comments
Descripción

General Narrative Comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1135957
Repeat Concomitant Medication
Descripción

Repeat Concomitant Medication

Alias
UMLS CUI-1
C2347852
Sequence Number
Descripción

Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Drug Name (Trade Name preferred)
Descripción

Drug Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Modified reported term
Descripción

Modified reported term

Tipo de datos

text

Alias
UMLS CUI [1]
C2826819
Concomitant Medication Unit dose
Descripción

Unit dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2826646
Concomitant medication Units
Descripción

Concomitant medication Units

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Concomitant Medication Frequency
Descripción

Concomitant Medication Frequency

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826654
Concomitant Medication Route
Descripción

Concomitant Medication Route

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826730
Reason for Medication
Descripción

Reason for Medication

Tipo de datos

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication Start Date and Time
Descripción

Concomitant Medication Start Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826825
Concomitant Medication taken prior to study?
Descripción

Concomitant Medication taken prior to study?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C1883727
UMLS CUI [1,4]
C0332152
Is Concomitant Medication ongoing?
Descripción

Concomitant Medication ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
If Concomitant Medication is not ongoing, specify End Date and Time.
Descripción

Concomitant Medication End Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826666
UMLS CUI [2]
C2826815
Repeat Electronically transferred lab data
Descripción

Repeat Electronically transferred lab data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Laboratory Test Type
Descripción

Laboratory Test Type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Date and time sample taken
Descripción

Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Repeat Vital signs
Descripción

Repeat Vital signs

Alias
UMLS CUI-1
C0518766
Actual Date and Time
Descripción

Actual Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C1264639
Blood pressure (systolic/ diastolic)
Descripción

Blood Pressure

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Descripción

heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Repeat 12- Lead ECG
Descripción

Repeat 12- Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Descripción

Date and Time of ECG

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1264639
Heart rate
Descripción

heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Descripción

Electrocardiogram: P-R interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Descripción

QRS complex duration (observable entity)

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Descripción

QT interval - finding

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1287082
msec
Method of QTc Calculation
Descripción

Electrocardiogram QT corrected interval; Evaluation Method

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
If QTc interval was calculated mechanically, check method of caluclation
Descripción

Electrocardiogram QT corrected interval; Evaluation Method; Mechanical Methods

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0443254
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
Descripción

QTcB - Bazett's Correction Formula; Mechanical Methods

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0443254
msec
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
Descripción

QTcF - Fridericia's Correction Formula; Mechanical Methods; Finding

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0443254
UMLS CUI [1,3]
C0243095
msec
If QTc interval was calcualted manually, check method of caluclation.
Descripción

Electrocardiogram QT corrected interval; Evaluation Method; Manual

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0175674
If QTc interval was calculated manually with RR interval, enter finding.
Descripción

Electrocardiogram QT corrected interval; Manual; Finding

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C0175674
UMLS CUI [1,3]
C0243095
msec
Result of ECG
Descripción

EKG finding

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
Repeat ECG Abnormalities
Descripción

Repeat ECG Abnormalities

Alias
UMLS CUI-1
C0522055
Date and Time of ECG
Descripción

Date and Time of ECG

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1264639
Record clinically significant abnormalities. Check all that apply. - Rhythm
Descripción

Record clinically significant abnormalities - Rhythm

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0871269
If other abnormal rhythm, enter comment.
Descripción

Other abnormal rhythm

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0947611
Record clinically significant abnormalities. Check all that apply. - P- Wave Morphology
Descripción

Record clinically significant abnormalities - P- Wave Morphology

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0429084
If other morphology, enter comment.
Descripción

Other morphology

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0947611
Record clinically significant abnormalities. Check all that apply. - Conduction
Descripción

Record clinically significant abnormalities - Conduction

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0232217
If other conduction, enter comment.
Descripción

Other conduction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0205394
Record clinically significant abnormalities. Check all that apply. - Myocardial infarction
Descripción

Record clinically significant abnormalities - Myocardial infarction

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0027051
If other myocardial infarction, enter comment.
Descripción

Other myocardial infarction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
Record clinically significant abnormalities. Check all that apply. - Depolarisation/ Repolarisation
Descripción

Record clinically significant abnormalities - Depolarisation/ Repolarisation

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0948857
UMLS CUI [3]
C1395184
If other depolarisation/ repolarisation, enter comment.
Descripción

Other depolarisation/ repolarisation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1395184
UMLS CUI [2,2]
C0205394
If other ECG abnormalities, enter comment.
Descripción

Other ECG abnormalities

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
Repeat Pharmacodynamics - Cortisol
Descripción

Repeat Pharmacodynamics - Cortisol

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0020268
Date/ time of sample
Descripción

Date/ time of sample

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Repeat Pharmacodynamics Results - Glucose
Descripción

Repeat Pharmacodynamics Results - Glucose

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0017725
UMLS CUI-3
C1254595
Date and Time of sample
Descripción

Date and Time of sample

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
Analyte result
Descripción

Analyte result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0443354
UMLS CUI [1,2]
C1274040
Analyte numeric result
Descripción

Analyte numeric result

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0443354
UMLS CUI [1,2]
C2347373
Analyte Text result
Descripción

Analyte Text result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0443354
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1527021
Repeat Pharmacodynamics Results - Potassium
Descripción

Repeat Pharmacodynamics Results - Potassium

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0032821
UMLS CUI-3
C1254595
Date and Time of sample
Descripción

Date and Time of sample

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
Analyte result
Descripción

Analyte result

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0443354
UMLS CUI [1,2]
C1274040
Analyte numeric result
Descripción

Analyte numeric result

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0443354
UMLS CUI [1,2]
C2347373
Analyte Text result
Descripción

Analyte Text result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0443354
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1527021
Repeat Pharmacokinetics Blood - FF/GW642444M
Descripción

Repeat Pharmacokinetics Blood - FF/GW642444M

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Actual Date/ Time
Descripción

Actual Date/ Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C1264639
Repeat Defective Inhaler
Descripción

Repeat Defective Inhaler

Alias
UMLS CUI-1
C0021461
UMLS CUI-2
C0332452
Investigational product container number
Descripción

Investigational product container number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Mark all applicable reasons for inhaler malfunction.
Descripción

Reasons for inhaler malfunction

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0021461
UMLS CUI [1,2]
C0086138
UMLS CUI [1,3]
C0566251
If other reason for inhaler malfunction, specify.
Descripción

Other reason for inhaler malfunction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0021461
UMLS CUI [1,2]
C0086138
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Repeat X Ray Pneumonia Confirmation
Descripción

Repeat X Ray Pneumonia Confirmation

Alias
UMLS CUI-1
C3843750
Date of x-ray
Descripción

Date of x-ray

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1306645
UMLS CUI [1,2]
C0011008
Findings consistent with diagnosis of pneumonia
Descripción

Findings consistent with diagnosis of pneumonia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032285
UMLS CUI [1,2]
C0243095
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Similar models

Logs/ Repeats, Non- Serious Adverse Event, Serious Adverse Event, Concomitant Medication, Electronically Transferred Lab Data, Vital Signs, ECG, Repeat Pharmacodynamics - Cortisol, Glucose, Potassium, FF/GWG642444M, Defective Inhaler, X Ray Pneumonia Confirmation

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Logs and Repeats - Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C1516048 (UMLS CUI-3)
Concomitant Medications
Item
Were any concomitant medications taken by the study subject during the study?
boolean
C2347852 (UMLS CUI [1])
Non- serious Adverse Events
Item
Did the subject experience any non- serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Serious Adverse Events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Hematology, Urinalysis or Clinical Chemistry Samples taken
Item
Were any repeat hematology, urinalysis or clinical chemistry samples taken?
boolean
C0018943 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2,1])
C1277698 (UMLS CUI [2,2])
C0008000 (UMLS CUI [3,1])
C1277698 (UMLS CUI [3,2])
Vital Signs recorded
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1])
Cortisol pharmacodynamic samples taken
Item
Were any repeat Cortisol pharmacodynamic samples taken?
boolean
C0201968 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,3])
Glucose pharmacodynamic samples
Item
Were any repeat Glucose pharmacodynamic samples taken?
boolean
C0017725 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,3])
Potassium pharmacodynamic samples
Item
Were any repeat Potassium pharmacodynamic samples taken?
boolean
C0032821 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,3])
Pharmacokinetic samples
Item
Were any repeat pharmacokinetic samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
undefined item
Item
Did the subject experience any Investigational Product Device Malfunctions?
boolean
C0304229 (UMLS CUI [1,1])
C0086138 (UMLS CUI [1,2])
X- rays taken for suspected Pneumonia
Item
Were any chest x- rays taken for suspected Pneumonia?
boolean
C0039985 (UMLS CUI [1,1])
C0277540 (UMLS CUI [1,2])
C0032285 (UMLS CUI [1,3])
Liver chemistry results reached or exceeded stopping criteria
Item
Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
boolean
C0023884 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2746065 (UMLS CUI [2,2])
Item Group
Non- serious Adverse Event
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Event (Diagnosis only (if known), otherwise Sign/ Symptom
Item
Event (Diagnosis only (if known), otherwise Sign/ Symptom
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2])
Non Serious Adverse Event Start Date and Time
Item
Non Serious Adverse Event Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Non- Serious Adverse Event End Date and Time
Item
Non- Serious Adverse Event End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Non- Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non- Serious Adverse Event Outcome
Code List
Non- Serious Adverse Event Outcome
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered / Not resolved (3)
CL Item
Recovered/ Resolved with sequelae, provide End Date and Time (4)
Item
Non- Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non- Serious Adverse Event Frequency
Code List
Non- Serious Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Non- Serious Adverse Event Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non- Serious Adverse Event Maximum Intensity
Code List
Non- Serious Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Non- serious Adverse Event Maximum Grade
integer
C2985911 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Maximum Grade of Non- serious Adverse Event
Code List
Non- serious Adverse Event Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Non- serious Adverse Event Maximum Grade or Intensity
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
undefined item
Code List
Non- serious Adverse Event Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with Investigational Product(s) as a Result of the AE
Code List
Action taken with Investigational Product(s) as a Result of the AE
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 (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Duration of AE
Item
Duration of AE if < 24 hours
text
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
text
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Item
Serious Adverse Event Initial Report
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Serious Adverse Event Initial Report
Code List
Serious Adverse Event Initial Report
CL Item
Initial (1)
Item
Serious Adverse Event Follow- up Report
integer
C1704685 (UMLS CUI [1])
Follow- up Report
Code List
Serious Adverse Event Follow- up Report
CL Item
Follow- Up (1)
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Modified term
Item
Serious Adverse Event Modified term
text
C2826798 (UMLS CUI [1])
MedDRA synoym
Item
Serious Adverse Event MedDRA synoym
text
C1519255 (UMLS CUI [1,1])
C1552878 (UMLS CUI [1,2])
Serious Adverse Event MedDRA lower level code
Item
Serious Adverse Event MedDRA lower level code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event Start Date and Time
Item
Serious Adverse Event Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C2826806 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event Outcome
Code List
Serious Adverse Event Outcome
CL Item
Recovered/ Resolved, provide End Date and Time (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with seguelae, provide End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
Serious Adverse Event End Date and Time / Date and Time of Death
Item
Serious Adverse Event End Date and Time / Date and Time of Death
datetime
C1519255 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
C3899439 (UMLS CUI [2])
Item
Serious Adverse Event Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event Maximum Intensity
Code List
Serious Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action taken with Investigational Product(s) as a Result of the AE integer
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with Investigational Product(s) as a Result of the AE
Code List
Action taken with Investigational Product(s) as a Result of the AE integer
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 (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Was SAE caused by activities related to study participation?
Item
Was SAE caused by activities related to study participation (e.g. procedure)?
boolean
C1519255 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Seriousness of Adverse Event
text
C1710056 (UMLS CUI [1])
Seriousness of Adverse Event
Code List
Seriousness of Adverse Event
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 anormaly/ birth defect (E)
CL Item
Other, specify within general narrative comment (F)
CL Item
Is associated with liver injury and impaired liver function defined as ALT 3x ULN and total bilirubin 2x ULN or INR >1.5 (G)
Item Group
Relevant medical conditions/ risk factors
C0012634 (UMLS CUI-1)
C0035648 (UMLS CUI-3)
MHx Sequence Number
Item
MHx Sequence Number
integer
C2348184 (UMLS CUI [1])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Medical Conditions Date of onset
Item
Medical Conditions Date of onset
date
C1513041 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Is medical condition continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Is medical condition continuing?
Code List
Is medical condition continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Medical condition date of last occurence
Item
If medical condition is not continuing, specify date of last occurence.
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Relevant Medical History / Risk Factors not noted above
Item
Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1])
C0035648 (UMLS CUI [2])
Item Group
Relevant Concomitant/ Treatment Medications
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
CM Sequence Number
Item
CM Sequence Number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name (Trade Name preferred)
text
C2360065 (UMLS CUI [1])
Medication Dose
Item
Medication Dose
float
C3174092 (UMLS CUI [1])
Item
Medication Dose Unit
integer
C3174092 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Medication Dose Unit
Code List
Medication Dose Unit
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
International units per mililitre (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
Lozenge (14)
CL Item
Megaunits (milion units) (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG) (17)
CL Item
Microgram/ kilogram (18)
CL Item
Microgram/ kilogram per minute (19)
CL Item
Micrograms per minute (20)
CL Item
Microlitre (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent (25)
CL Item
Milligram per hour (26)
CL Item
Mliligram/ kilogram (27)
CL Item
Milligram/ kilogram per hour (28)
CL Item
Milligram/ kilogram per minute (29)
CL Item
Milligram/ metre squared (30)
CL Item
Milligram/ millilitre (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour (33)
CL Item
Millilitre per minute (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration (37)
CL Item
Nebule (38)
CL Item
Patch (39)
CL Item
Percent (40)
CL Item
Puff (41)
CL Item
Sachet (42)
CL Item
Spray (43)
CL Item
Suppository (44)
CL Item
Tablespoon (45)
CL Item
Tablet (46)
CL Item
Teaspoon (47)
CL Item
Units (48)
CL Item
Unknown (49)
CL Item
Vial (50)
Item
Medication Frequency
integer
C3476109 (UMLS CUI [1])
Medication Frequency
Code List
Medication Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per week (4)
CL Item
5 times per day (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continious infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TID (31)
CL Item
Unknown (32)
Item
Medication route
integer
C0013153 (UMLS CUI [1])
Medication route
Code List
Medication route
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra- arterial (6)
CL Item
Intra- bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intaosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutanesous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Medication Start Date
Item
Medication Start Date
datetime
C2826734 (UMLS CUI [1])
Is Concomitant Medication ongoing?
Item
Is Concomitant Medication ongoing?
boolean
C2826666 (UMLS CUI [1])
If Concomitant Medication is not ongoing, sepcify End Date
Item
If Concomitant Medication is not ongoing, sepcify End Date
date
C2826666 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Primary Indication for concomitant/ treatment medications
Item
Primary Indication for concomitant/ treatment medications
text
C3146298 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Item
Drug type
integer
C0457591 (UMLS CUI [1])
Drug type
Code List
Drug type
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Relevant Diagnostic Results
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Lab Sequence Number
Item
Lab Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item
Test Name
integer
C2826273 (UMLS CUI [1])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline Phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicabonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C- reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV 1 (30)
CL Item
Gamma- glutamyltransferase (31)
CL Item
Glutamic- oxalacetic transferase (32)
CL Item
Glutamic- pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV- DNA decreased (35)
CL Item
HBV- DNA increased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Monocytes (51)
CL Item
Neutrophils (52)
CL Item
Oxygen saturation (53)
CL Item
pCO2 (54)
CL Item
pH (55)
CL Item
Phosphate (56)
CL Item
Platelet count (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin I (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0456984 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1])
Normal Low Range
Item
Normal Low Range
text
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
If investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0304229 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
undefined item
Code List
If investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown (U)
CL Item
Not applicable (X)
Item Group
General Narrative Comments
C0947611 (UMLS CUI-1)
C1135957 (UMLS CUI-2)
General Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1,1])
C1135957 (UMLS CUI [1,2])
Item Group
Repeat Concomitant Medication
C2347852 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name (Trade Name preferred)
text
C2360065 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Unit dose
Item
Concomitant Medication Unit dose
text
C2826646 (UMLS CUI [1])
Item
Concomitant medication Units
integer
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant medication Units
Code List
Concomitant medication Units
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Area under curve (4)
CL Item
Bottle (5)
CL Item
Capsule (6)
CL Item
Cubic centimeter (7)
CL Item
Cup (8)
CL Item
Gamma per kilogram per minute (9)
CL Item
Gram (10)
CL Item
Drops (11)
CL Item
100 International units/ ml (12)
CL Item
Inhalation (13)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour (16)
CL Item
International units per millilitre (17)
CL Item
Litre (18)
CL Item
Lozenge (19)
CL Item
Litre per minute (20)
CL Item
Minimum alveolar concentration (21)
CL Item
Mega becquerels (MBq) (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour (24)
CL Item
Microgram/ kilogram (25)
CL Item
Microgram/ kilogram per minute (26)
CL Item
Micrograms per minute (27)
CL Item
Micrograms per millilitre (28)
CL Item
Microlitre (29)
CL Item
Milliequivalent (30)
CL Item
Milliequivalent per 24 hours (31)
CL Item
Milligram (32)
CL Item
Milligram per day (33)
CL Item
Milligram per hour (34)
CL Item
Milligram/ kilogram (35)
CL Item
Milligram/ kilogram per hour (36)
CL Item
Milligram/ kilogram per minute (37)
CL Item
Milligram/ metre squared (38)
CL Item
Milligram/ millilitre (39)
CL Item
Milligrams percent (40)
CL Item
Million international units (41)
CL Item
Millilitre (42)
CL Item
Millilitre per hour (43)
CL Item
Millilitre per minute (44)
CL Item
Millimole (45)
CL Item
Megaunits (million units) (46)
CL Item
Nebule (47)
CL Item
Ounce (48)
CL Item
Patch (49)
CL Item
Percent (50)
CL Item
Puff (51)
CL Item
Sachet (52)
CL Item
Spray  (53)
CL Item
Suppository (54)
CL Item
Tablet (55)
CL Item
Tablespoon (56)
CL Item
Teaspoon (57)
CL Item
Microgram (UG) (58)
CL Item
Units per hour (59)
CL Item
Units per kilogram per minute (60)
CL Item
Units per minute (61)
CL Item
Units (62)
CL Item
Unknown (63)
CL Item
Vial (64)
Item
Concomitant Medication Frequency
integer
C2826654 (UMLS CUI [1])
Concomitant Medication Frequency
Code List
Concomitant Medication Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
HS (9)
CL Item
Once daily (10)
CL Item
Once only (11)
CL Item
PC (12)
CL Item
PRN (13)
CL Item
Q12H (14)
CL Item
Q2H (15)
CL Item
Every 2 weeks (16)
CL Item
Q3D (17)
CL Item
Every 3 months (18)
CL Item
Every 3 weeks (19)
CL Item
Q4D (20)
CL Item
Q4H (21)
CL Item
Q6H (22)
CL Item
Q8H (23)
CL Item
QAM (24)
CL Item
QH (25)
CL Item
QID (26)
CL Item
Once a month (27)
CL Item
Every other day (28)
CL Item
QPM (29)
CL Item
Once a week (30)
CL Item
TID (31)
CL Item
Unknown (32)
Item
Concomitant Medication Route
integer
C2826730 (UMLS CUI [1])
Concomitant Medication Route
Code List
Concomitant Medication Route
CL Item
Epidural (1)
CL Item
Gastrostomy tube (2)
CL Item
Intra- arterial (3)
CL Item
Intra- articular (4)
CL Item
Intra- bursa (5)
CL Item
Intradermal (6)
CL Item
Inhalation (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intrathecal (15)
CL Item
Intrauterine (16)
CL Item
Intravenous (17)
CL Item
Nasogastric (18)
CL Item
Nasal (19)
CL Item
Right eye (20)
CL Item
Ophthalmic (21)
CL Item
Left eye (22)
CL Item
Otic (23)
CL Item
Other (24)
CL Item
Both eyes (25)
CL Item
Oral (26)
CL Item
Rectal (27)
CL Item
Subcutaneous (28)
CL Item
Sublingual (29)
CL Item
Transdermal (30)
CL Item
Topical (31)
CL Item
Unknown (32)
CL Item
Vaginal (33)
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Start Date and Time
Item
Concomitant Medication Start Date and Time
datetime
C2826825 (UMLS CUI [1])
Concomitant Medication taken prior to study?
Item
Concomitant Medication taken prior to study?
boolean
C2347852 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Concomitant Medication ongoing
Item
Is Concomitant Medication ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication End Date and Time
Item
If Concomitant Medication is not ongoing, specify End Date and Time.
datetime
C2826666 (UMLS CUI [1])
C2826815 (UMLS CUI [2])
Item Group
Repeat Electronically transferred lab data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Laboratory Test Type
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Laboratory Test Type
Code List
Laboratory Test Type
CL Item
Hematology (H)
CL Item
Clinical Chemistry (C)
CL Item
Urinalysis (U)
Date and time sample taken
Item
Date and time sample taken
datetime
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Repeat Vital signs
C0518766 (UMLS CUI-1)
Actual Date and Time
Item
Actual Date and Time
datetime
C1264639 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Repeat 12- Lead ECG
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C1623258 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Electrocardiogram QT corrected interval; Evaluation Method
Code List
Method of QTc Calculation
CL Item
Machine; record QTc value(s) generated by the machine  (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of caluclation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Electrocardiogram QT corrected interval; Evaluation Method; Mechanical Methods
Code List
If QTc interval was calculated mechanically, check method of caluclation
CL Item
QTcB (Bazett)  (B)
CL Item
QTcF (Fridericia) (F)
QTcB - Bazett's Correction Formula; Mechanical Methods
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
QTcF - Fridericia's Correction Formula; Mechanical Methods; Finding
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Electrocardiogram QT corrected interval; Evaluation Method; Manual
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval  (RR)
CL Item
RR interval not available (NA)
Electrocardiogram QT corrected interval; Manual; Finding
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
EKG finding
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Repeat ECG Abnormalities
C0522055 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C1623258 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities. Check all that apply. - Rhythm
integer
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0871269 (UMLS CUI [2])
Record clinically significant abnormalities
Code List
Record clinically significant abnormalities. Check all that apply. - Rhythm
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40 - 50 beats/ min) (2)
CL Item
Sinus bradycardia (heart rate <30 beats/ min) (3)
CL Item
Sinus pause (4)
CL Item
Sinus tachycardia (heart rate >100 beats/ min) (5)
CL Item
Ectopic supraventricular beats (6)
CL Item
Ectopic supraventricular rhythm (7)
CL Item
Wandering atrial pacemaker (8)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/ min) (9)
CL Item
Supraventricular tachycardia (heart rate >100 beats/ min) (10)
CL Item
Atrial flutter (11)
CL Item
Atrial fibrillation (12)
CL Item
Junctional rhythm (13)
CL Item
Junctional tachycardia (heart rate <= 100 beats/ min) (14)
CL Item
Ectopic ventricular beats (15)
CL Item
Ventricular couplets (16)
CL Item
Bigeminy (17)
CL Item
Trigeminy (18)
CL Item
Electrical alternans (19)
CL Item
R on T phenomenon (20)
CL Item
Ventricular fibrillation (21)
CL Item
Idioventricular rhythm (22)
CL Item
Sustained ventricular tachycardia (23)
CL Item
Non- sustained ventricular tachycardia (24)
CL Item
Wide QRS tachycardia (diagnosis unknown) (25)
CL Item
Ventricular tachycardia (26)
CL Item
Monomorphic ventricular tachycardia (27)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (28)
CL Item
Polymorphic (sustained and non- sustained) ventricular tachycardia (29)
CL Item
Artificial Pacemaker (30)
CL Item
Other abnormal rhythm, enter comment (31)
Other abnormal rhythm
Item
If other abnormal rhythm, enter comment.
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
Record clinically significant abnormalities. Check all that apply. - P- Wave Morphology
integer
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0429084 (UMLS CUI [2])
undefined item
Code List
Record clinically significant abnormalities. Check all that apply. - P- Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology, enter comment (6)
Other morphology
Item
If other morphology, enter comment.
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
Record clinically significant abnormalities. Check all that apply. - Conduction
integer
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
Record clinically significant abnormalities - Conduction
Code List
Record clinically significant abnormalities. Check all that apply. - Conduction
CL Item
First degree AV block (RR interval >200msec) (1)
CL Item
Short PR interval (2)
CL Item
Second degree AV block (Mobitz type 1) (3)
CL Item
Second degree AV block (Mobitz type 2) (4)
CL Item
AV block (5)
CL Item
Third degree AV block (6)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (7)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (8)
CL Item
Incomplete right bundle branch block (9)
CL Item
Incomplete left bundle branch block (10)
CL Item
Right bundle branch block (11)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
Left bundle branch block (14)
CL Item
Bifascicular block (15)
CL Item
Non- specific intraventricular conduction delay (QRS>= 120 msec) (16)
CL Item
Accessory pathway (Wolff- Parkinson White, Lown- Ganong- Levine) (17)
CL Item
Prolonged QT interval (18)
CL Item
QT/ QTc prolongation >= 500 msec) (19)
CL Item
AV dissociation (20)
CL Item
Other conduction, enter comment (21)
Other conduction
Item
If other conduction, enter comment.
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities. Check all that apply. - Myocardial infarction
integer
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Record clinically significant abnormalities - Myocardial infarction
Code List
Record clinically significant abnormalities. Check all that apply. - Myocardial infarction
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocaridal infarction, septal (6)
CL Item
Myocardial infarction, Non- Q- wave (7)
CL Item
Other myocardial infarction, enter comment (8)
Other myocardial infarction
Item
If other myocardial infarction, enter comment.
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities. Check all that apply. - Depolarisation/ Repolarisation
integer
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C1395184 (UMLS CUI [3])
Record clinically significant abnormalities - Depolarisation/ Repolarisation
Code List
Record clinically significant abnormalities. Check all that apply. - Depolarisation/ Repolarisation
CL Item
Non- specific ST- T changes (1)
CL Item
J point elevation (2)
CL Item
ST- elevation (3)
CL Item
ST- elevation- pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T- waves (11)
CL Item
Low QRS voltage (12)
CL Item
T- wave flattening/ inversion (13)
CL Item
Other depolarisation/ repolarisation, enter comment (14)
Other depolarisation/ repolarisation
Item
If other depolarisation/ repolarisation, enter comment.
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1395184 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Other ECG abnormalities
Item
If other ECG abnormalities, enter comment.
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Repeat Pharmacodynamics - Cortisol
C0851347 (UMLS CUI-1)
C0020268 (UMLS CUI-2)
Date/ time of sample
Item
Date/ time of sample
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item Group
Repeat Pharmacodynamics Results - Glucose
C0851347 (UMLS CUI-1)
C0017725 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Date and Time of sample
Item
Date and Time of sample
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Analyte result
integer
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Analyte result
Code List
Analyte result
CL Item
Numeric result  (1)
CL Item
Text result (2)
Analyte numeric result
Item
Analyte numeric result
float
C0443354 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Analyte Text result
Item
Analyte Text result
text
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
Item Group
Repeat Pharmacodynamics Results - Potassium
C0851347 (UMLS CUI-1)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Date and Time of sample
Item
Date and Time of sample
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Analyte result
integer
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Analyte result
Code List
Analyte result
CL Item
Numeric result  (1)
CL Item
Text result (2)
Analyte numeric result
Item
Analyte numeric result
float
C0443354 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Analyte Text result
Item
Analyte Text result
text
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
Item Group
Repeat Pharmacokinetics Blood - FF/GW642444M
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Actual Date/ Time
Item
Actual Date/ Time
datetime
C1264639 (UMLS CUI [1])
Item Group
Repeat Defective Inhaler
C0021461 (UMLS CUI-1)
C0332452 (UMLS CUI-2)
Investigational product container number
Item
Investigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
Mark all applicable reasons for inhaler malfunction.
integer
C0021461 (UMLS CUI [1,1])
C0086138 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Reasons for inhaler malfunction
Code List
Mark all applicable reasons for inhaler malfunction.
CL Item
Mouthpiece Cover does not stay at the fully actuated position (20)
CL Item
Mouthpiece cover came apart from the machanism (21)
CL Item
Inhaler is cracked or broken apart (22)
CL Item
Difficult to open mouthpiece cover/ force to acuate was too high (23)
CL Item
Difficult to close mouthpiece cover (24)
CL Item
Powder fell out prior to use (25)
CL Item
No powder came out (26)
CL Item
Device squeaks in operation (27)
CL Item
Device rattles in operation (28)
CL Item
Dose counter did not count (29)
CL Item
Dose counter is ambiguous (30)
CL Item
Dose counter overcounted (31)
CL Item
Dose counter undercounted (32)
CL Item
Difficult to pull air through the device as described in the leaflet (33)
CL Item
Device smelt/ bad odour when pack opened (34)
CL Item
Other, specify (35)
Other reason for inhaler malfunction
Item
If other reason for inhaler malfunction, specify.
text
C0021461 (UMLS CUI [1,1])
C0086138 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Repeat X Ray Pneumonia Confirmation
C3843750 (UMLS CUI-1)
Date of x-ray
Item
Date of x-ray
date
C1306645 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Findings consistent with diagnosis of pneumonia
Item
Findings consistent with diagnosis of pneumonia
boolean
C0032285 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
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