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Informations:
Erreur:
ID
33701
Description
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Serious Adverse Events (SAE). It has to be filled in if a SAE occurs during study.
Lien
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Mots-clés
Versions (3)
- 20/12/2018 20/12/2018 -
- 20/12/2018 20/12/2018 -
- 21/12/2018 21/12/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
20 décembre 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate combination on electrocardiographic parameters in healthy subjects, NCT01209026
Serious Adverse Events (SAE)
- StudyEvent: ODM
Similar models
Serious Adverse Events (SAE)
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Initial Report
Item
Initial Report
boolean
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,2])
Follow-Up Report
Item
Follow-Up Report
boolean
C1704685 (UMLS CUI [1])
Item
Did SAE occur after initiation of study medication?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
SAE Sequence Number
Item
SAE Sequence Number [hidden]
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
SAE Diagnosis
Item
SAE Diagnosis
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Modified term
Item
Modified term [hidden]
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym [hidden]
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
MedDRA lower level term code
Item
MedDRA lower level term code [hidden]
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding [hidden]
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
Start date of SAE
Item
Start date of SAE
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Start time of SAE
Item
Start time of SAE
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End date of SAE, Date of death
Item
End date of SAE, Date of death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
End time of SAE, Time of death
Item
End time of SAE, Time of death
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1301931 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C1301931 (UMLS CUI [2])
Item
Maximum Intensity of SAE
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not aplicable (X)
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 (X)
Item
Maximum Grade or Intensity [hidden]
text
C0441800 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C1710056 (UMLS CUI [2])
C1710066 (UMLS CUI [1,2])
C1710056 (UMLS CUI [2])
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 (X)
Item
Action Taken with investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with investigational Product(s) as a Result of the SAE
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this SAE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0678227 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Duration of SAE
Item
Duration of SAE if < 24 hours (hidden)
time
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose [hidden]
time
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
text
C1997894 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Was SAE caused by activities related to study participation (e.g. procedures)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the event serious? [hidden]
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
Hospitalization/ prolongation of existing hospitalization
Item
Requires hospitalization or prolongation of existing hospitalization
boolean
C0019993 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1])
Liver injury and impaired liver function, ALT, total bilirubin
Item
Is associated with liver injury and impaired liver function defined as: ALT >= 3xULN, and either total bilirubin >=2xULN or INR > 1.5
boolean
C0160390 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0086565 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
Item Group
Relevant concomitant/treatment medications Entry
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
CM Sequenz number
Item
CM Sequenz number [hidden]
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Drug Dose
Item
Drug Dose
integer
C0869039 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (AP)
CL Item
Bottle (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Drops (031)
CL Item
Gram (002)
CL Item
International units (025)
CL Item
International units per kilogram (028)
CL Item
International units per millilitre (IUML)
CL Item
Litre (011)
CL Item
Litre per minute (LM)
CL Item
Lozenge (LOZ)
CL Item
Megaunits (million units) (MEGU)
CL Item
Microgram (UG) (004)
CL Item
Microgram (UG) (004)
CL Item
Microgram/kilogram (008)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Microlitre (013)
CL Item
Milliequivalent (029)
CL Item
Milliequivalent per 24 hours (MEQ24)
CL Item
Milligram (003)
CL Item
Milligrams percent (MGPER)
CL Item
Milligram per hour (MGH)
CL Item
Milligram/kilogram (007)
CL Item
Milligram/kilogram per hour (MGKH)
CL Item
Milligram/kilogram per minute (MGKM)
CL Item
Milligram/metre squared (009)
CL Item
Milligram/millilitre (MGML)
CL Item
Millilitre (012)
CL Item
Millilitre per hour (MLH)
CL Item
Millilitre per minute (MLM)
CL Item
Millimole (023)
CL Item
Million International units (027)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nebule (NEB)
CL Item
Patch (PAT)
CL Item
Percent (030)
CL Item
Puff (PUFF)
CL Item
Sachet (SAC)
CL Item
Spray (SPR)
CL Item
Suppository (SUP)
CL Item
Tablespoon (TBS)
CL Item
Tablet (TAB)
CL Item
Teaspoon (TSP)
CL Item
Units (UNT)
CL Item
Unknown (U)
CL Item
Vial (VIA)
CL Item
2 times per week (2W)
CL Item
3 times per week (3W)
CL Item
4 times per week (4W)
CL Item
5 times per day (5D)
CL Item
5 times per week (5W)
CL Item
AC (AC)
CL Item
Q12H (2D)
CL Item
Continuous infusion (CO)
CL Item
Every 2 weeks (FO)
CL Item
Every 3 weeks (Q3WK)
CL Item
Every 3 months (Q3M)
CL Item
Every other day (AD)
CL Item
QPM (1N)
CL Item
Once a month (MO)
CL Item
Once aweek (WE)
CL Item
Once daily (1D)
CL Item
Once only (1S)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q2H (12D)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
Q4H (6D)
CL Item
QID (4D)
CL Item
TID (3D)
CL Item
Q12H (2D)
CL Item
QAM (1M)
CL Item
QH (24D)
CL Item
QID (4D)
CL Item
QPM (1N)
CL Item
TID (3D)
CL Item
Unknown (U)
CL Item
Both eyes (047)
CL Item
Epidural (008)
CL Item
Gastrostomy tube (GT)
CL Item
Inhalation (055)
CL Item
Injection (INJ)
CL Item
Intra-arterial (013)
CL Item
Intra-bursa (IBU)
CL Item
Intralesional (026)
CL Item
Intramuscular (030)
CL Item
Nasal (045)
CL Item
Intraocular (031)
CL Item
lntraosteal (IOS)
CL Item
Intraperitoneal (033)
CL Item
Intrathecal (037)
CL Item
Intrauterine (015)
CL Item
Intravenous (042)
CL Item
Nasal (045)
CL Item
Oral (048)
CL Item
Rectal (054)
CL Item
Subcutaneous (058)
CL Item
Subtingual (060)
CL Item
Topical (061)
CL Item
Transdermal (062)
CL Item
Unknown (065)
CL Item
Vaginal (067)
Date started
Item
Date started
date
C0808070 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
Primary indication
Item
Primary indication
text
C3146298 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Cause of SAE (1)
CL Item
Concomitant (2)
CL Item
Treatment (T)
Item Group
Relevant medical conditions/risk factors Entry
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
MHx sequence Number
Item
MHx sequence Number [hidden]
text
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Date of last occurence
Item
If no continuing, please specify date of last occurence
date
C2745955 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
Relevant medical history/ risk factors
Item
Relevant medical history/ risk factors not noted above
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Relevant diagnostic results Entry
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0456984 (UMLS CUI-2)
Lab Sequence Number
Item
Lab Sequence Number [hidden]
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (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
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Blllrubln 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
CDS lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C-reactlve 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
FEV1 (30)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic 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
pC02 (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
boolean
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (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])
C1518030 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,2])
C1518030 (UMLS CUI [1,3])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
Relevant diagnostic results
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 one reported event(s) recur fter further investigational product(s) were administered?
text
C0034897 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Code List
If investigational product(s) stopped, did one reported event(s) recur fter further investigational product(s) were administered?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
General narrative comment
Item
General narrative comment
text
C0947611 (UMLS CUI [1])
Incomplete SAE
Item
Incomplete SAE [hidden]
boolean
C1710056 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,2])
Receipt by GSK date
Item
Receipt by GSK date [hidden]
date
C2985846 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
SAE Sequence Number
Item
SAE Sequence Number [hidden]
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number [hidden]
integer
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID [hidden]
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number [hidden]
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code [hidden]
text
C0805701 (UMLS CUI [1])
Email flag
Item
Email flag [hidden]
text
C0013849 (UMLS CUI [1])