ID

29425

Beschreibung

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Serious Adverse Event

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  1. 22.03.18 22.03.18 -
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GlaxoSmithKline

Hochgeladen am

22. März 2018

DOI

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GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587

Englisch

Serious Adverse Event

1 Formulare  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Serious Adverse Event
Beschreibung

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

integer

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

Randomisation Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Did the subject experience a serious adverse event during the study?
Beschreibung

serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Start Date
Beschreibung

Serious Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697888
Start Time Serious Adverse Event
Beschreibung

Start Time Serious Adverse Event

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697889
Serious Adverse Event End Date
Beschreibung

Serious Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697886
Serious Adverse Event End Time
Beschreibung

Serious Adverse Event End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826658
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1519255
Date of Death
Beschreibung

Date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
If fatal, was a post-mortem/autopsy performed
Beschreibung

autopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Maximum Toxicity
Beschreibung

Maximum Toxicity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Respect to Investigational Drug
Beschreibung

Action Taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Did the subject withdraw from study as a result of this AE?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Seriousness, Specify the reason for considering this an SAE
Beschreibung

Seriousness

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
Possible Cause of SAE Other Than Investigational Product(s):
Beschreibung

SAE Causation

Datentyp

integer

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
If other ossible Cause of SAE, specify
Beschreibung

SAE Causation

Datentyp

text

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Beschreibung

adverse event recur

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0034897
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

Serious Adverse Event Recurrence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
Beschreibung

Details of relevant Assessments

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1519255
General narrative comments
Beschreibung

General narrative comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Investigator’s signature
Beschreibung

Investigator’s signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Demography Data
Beschreibung

Demography Data

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kG
Alias
UMLS CUI [1]
C0005910
kG
Relevant medical conditions/Risk factors
Beschreibung

Relevant medical conditions/Risk factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
Specific Condition name
Beschreibung

Specific Condition name

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Date of onset
Beschreibung

Date of onset

Datentyp

date

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

Condition Present at Time of the SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
No, specify date of last occurrence
Beschreibung

date of last occurrence

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
Other RELEVANT Risk Factors
Beschreibung

Risk Factors

Datentyp

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Relevant concomitant medication/treatment
Beschreibung

Relevant concomitant medication/treatment

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0087111
UMLS CUI-3
C1519255
Drug name
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

float

Alias
UMLS CUI [1]
C2348070
Unit
Beschreibung

Unit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519795
Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Beschreibung

Taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beschreibung

start date of medication

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Beschreibung

End Date of medication

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Ongoing?
Beschreibung

Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Details of Investigational Product(s)
Beschreibung

Details of Investigational Product(s)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1519255
Investigational Product
Beschreibung

Investigational Product

Datentyp

integer

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beschreibung

Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Time of Dose
Beschreibung

Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

float

Maßeinheiten
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
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Ähnliche Modelle

Serious Adverse Event

1 Formulare
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0019994 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
serious adverse event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Start Time Serious Adverse Event
Item
Start Time Serious Adverse Event
time
C1519255 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Outcome
integer
C1624730 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving  (2)
CL Item
Not recovered/Not resolved  (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal, record Date of Death  (5)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
autopsy
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Toxicity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Maximum Toxicity
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
Action Taken with Respect to Investigational Drug
integer
C1547656 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken
Code List
Action Taken with Respect to Investigational Drug
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 (6)
Relationship 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])
C1519255 (UMLS CUI [1,3])
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
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Seriousness, Specify the reason for considering this an SAE
integer
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness, Specify the reason for considering this an SAE
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
Item
Possible Cause of SAE Other Than Investigational Product(s):
integer
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE Causation
Code List
Possible Cause of SAE Other Than Investigational Product(s):
CL Item
Disease under study  (1)
CL Item
Medical condition(s)  (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication  (5)
CL Item
Activity related to study participation  (6)
CL Item
Other, specify (7)
SAE Causation
Item
If other ossible Cause of SAE, specify
text
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
adverse event recur
Item
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
boolean
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
Serious Adverse Event Recurrence
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Details of relevant Assessments
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C0430022 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
General narrative comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Item Group
Demography Data
C0011298 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Relevant medical conditions/Risk factors
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Specific Condition name
Item
Specific Condition name
text
C0012634 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Condition Present at Time of the SAE
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
date of last occurrence
Item
No, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Relevant concomitant medication/treatment
C2347852 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
Item
Unit
integer
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Unit
Code List
Unit
CL Item
Actuation ACTU (1)
CL Item
Ampoule AMP (2)
CL Item
Application AP (3)
CL Item
Bottle BT (4)
CL Item
Capsule CAP (5)
CL Item
Cubic centimeter cc (6)
CL Item
Drops 031 (7)
CL Item
Gram 002 (8)
CL Item
International units  (9)
CL Item
International units per kilogram  (10)
CL Item
Internatcional units per millilitre IUML (11)
CL Item
Litre  (12)
CL Item
Litre per minute LM (13)
CL Item
Lozenge LOZ (14)
CL Item
Megaunits (million units) MEGU (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG)  (17)
CL Item
Microgram /kilogram (18)
CL Item
Microgram/kilogram per minute MCG/KG/MIN (19)
CL Item
Micrograms per minute MCG/MIN (20)
CL Item
Micro litre  (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours MEQ24 (23)
CL Item
Milligram  (24)
CL Item
Milligrams percent MGPER (25)
CL Item
Milligram per hour MGH (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour MGKH (28)
CL Item
Milligram/kilogram per minute MGKM (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre MGML (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour MLH (33)
CL Item
Millilitre per minute MLM (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration MAC (37)
CL Item
Nebule NEB (38)
CL Item
Patch PAT (39)
CL Item
Percent (40)
CL Item
Puff PUFF (41)
CL Item
Sachet SAC (42)
CL Item
Spray SPR (43)
CL Item
Suppository SUP (44)
CL Item
Tablespoon TBS (45)
CL Item
Tablet TAB (46)
CL Item
Teaspoon TSP (47)
CL Item
Units UNT (48)
CL Item
Unknown u (49)
CL Item
Vial VIA (50)
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
2 times per week 2W (1)
CL Item
3 times per week 3W (2)
CL Item
4times per week 4W (3)
CL Item
5 times per day 50 (4)
CL Item
5 times per week SW (5)
CL Item
AC AC (6)
CL Item
BID 2D (7)
CL Item
Continuous Infusion co (8)
CL Item
Every 2 weeks FO (9)
CL Item
Every 3 weeks Q3WK (10)
CL Item
Every 3 months Q3M (11)
CL Item
Every other day AD (12)
CL Item
At Bedtime IN (13)
CL Item
Once a month MO (14)
CL Item
Once a week WE (15)
CL Item
Once daily 1D (16)
CL Item
Once only 15 (17)
CL Item
PC PC  (18)
CL Item
PRN PRN (19)
CL Item
Q2H 12D (20)
CL Item
Q3D Q3D (21)
CL Item
Q4D Q4D (22)
CL Item
Q4H 6D (23)
CL Item
Q6H 4D (24)
CL Item
Q8H 3D (25)
CL Item
Q12H 2D (26)
CL Item
QAM lM (27)
CL Item
QH 24D (28)
CL Item
QID 4D (29)
CL Item
QPM lN (30)
CL Item
TIO 3D (31)
CL Item
Unknown u (32)
Item
Route
integer
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Both eyes 047 (1)
CL Item
Epidural 008 (2)
CL Item
Gastrostomy tube GT (3)
CL Item
Inhalation 055 (4)
CL Item
Injection INJ (5)
CL Item
Intra-arterial 013 (6)
CL Item
Intra-buru IBU (7)
CL Item
Intralesional 026 (8)
CL Item
IM Intramuscular 030 (9)
CL Item
Intranasal 045 (10)
CL Item
Intraocular 031 (11)
CL Item
Intraosteal 10S (12)
CL Item
Intraperitoneal 033 (13)
CL Item
lntrathecal 037 (14)
CL Item
Intrauterine 015 (15)
CL Item
IV Intravenous 042 (16)
CL Item
Nasal 045 (17)
CL Item
Oral 048 (18)
CL Item
Rectal 054 (19)
CL Item
Subcutaneous 058 (20)
CL Item
Sublingua1 060 (21)
CL Item
Topical 061 (22)
CL Item
Transdermal 062 (23)
CL Item
Unknown 065 (24)
CL Item
Vaginal 067 (25)
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Item Group
Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Investigational Product
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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