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ID
32361
Beschreibung
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
Stichworte
Versionen (1)
- 27/10/18 27/10/18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
27 ottobre 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125
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
Ähnliche Modelle
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
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Logs and Repeats - Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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)
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])
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])
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])
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])
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])
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])
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])
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])
C0008000 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2746065 (UMLS CUI [2,2])
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])
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])
C1705586 (UMLS CUI [1,2])
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])
C0439603 (UMLS CUI [1,2])
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])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
C0806909 (UMLS CUI [1,2])
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])
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])
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])
C1518404 (UMLS CUI [1,2])
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])
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])
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])
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])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Serious Adverse Event Initial Report
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
CL Item
Initial (1)
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])
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])
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])
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])
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])
C2826806 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
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])
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])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
C1518404 (UMLS CUI [1,2])
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])
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])
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])
C2348568 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
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)
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])
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])
C0574845 (UMLS CUI [1,2])
Item
Is medical condition continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
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])
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])
C0035648 (UMLS CUI [2])
Item Group
Relevant Concomitant/ Treatment Medications
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
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])
C0439148 (UMLS CUI [1,2])
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)
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)
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])
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])
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])
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)
C0456984 (UMLS CUI-2)
Lab Sequence Number
Item
Lab Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
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])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
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])
C0456984 (UMLS CUI [1,2])
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])
C0877248 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
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)
C1135957 (UMLS CUI-2)
General Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1,1])
C1135957 (UMLS CUI [1,2])
C1135957 (UMLS CUI [1,2])
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])
C0439148 (UMLS CUI [1,2])
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])
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)
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])
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])
C2826815 (UMLS CUI [2])
Item Group
Repeat Electronically transferred lab data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Laboratory Test Type
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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])
Date and Time of ECG
Item
Date and Time of ECG
datetime
C1623258 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
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])
C2911685 (UMLS CUI [1,2])
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])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
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])
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])
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])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
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])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
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)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C1623258 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
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])
C2826293 (UMLS CUI [1,2])
C0871269 (UMLS CUI [2])
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])
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])
C2826293 (UMLS CUI [1,2])
C0429084 (UMLS CUI [2])
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])
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])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
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])
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])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
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])
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])
C2826293 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C1395184 (UMLS CUI [3])
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])
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])
C0205394 (UMLS CUI [1,2])
Item Group
Repeat Pharmacodynamics - Cortisol
C0851347 (UMLS CUI-1)
C0020268 (UMLS CUI-2)
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])
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)
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])
C1264639 (UMLS CUI [1,2])
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])
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])
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)
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])
C1264639 (UMLS CUI [1,2])
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])
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])
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)
C0005767 (UMLS CUI-2)
Actual Date/ Time
Item
Actual Date/ Time
datetime
C1264639 (UMLS CUI [1])
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])
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])
C0086138 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
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])
C0086138 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Date of x-ray
Item
Date of x-ray
date
C1306645 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
C0243095 (UMLS CUI [1,2])