ID

30826

Description

Study part: Adverse Event. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Keywords

Versions (1)
  1. 6/24/18 6/24/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 24, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Adverse Event (AE) Pazopanib Macular Degeneration MD1103367

English

Adverse Event

1 forms  
  1. StudyEvent: ODM
    1. Adverse Event
ADVERSE EVENTS (AE)
Description

ADVERSE EVENTS (AE)

Alias
UMLS CUI-1
C0877248
Sequence Number
Description

Sequence Number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C1457887
Modified term
Description

MedDRA synonym; MedDRA lower level term code; Coding failed

Data type

text

Alias
UMLS CUI [1]
C2826302
Start Date and Time
Description

Start Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
When resolved/ recovered, provide end date and time
Description

end date and time

Data type

datetime

Alias
UMLS CUI [1]
C2826793
When resolved/ recovered with sequelae, provide end date and time
Description

end date and time

Data type

datetime

Alias
UMLS CUI [1]
C2826793
If Fatal, record date and time of death
Description

date and time of death

Data type

datetime

Alias
UMLS CUI [1]
C3899439
Frequency
Description

Adverse event Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439603
Maximum Intensity
Description

Adverse event Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Action taken with lnvestigational Product(s) as a result of the AE
Description

Action taken with lnvestigational Product

Data type

text

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

Withdrawal by Subject; Non-serious Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Adverse event study drug

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
Does this Adverse Event meet the definition of serious?
Description

serious adverse event

Data type

text

Alias
UMLS CUI [1]
C1519255
Yes, check all that apply
Description

serious adverse event

Data type

text

Alias
UMLS CUI [1]
C1519255
Other, specify
Description

specify

Data type

text

Alias
UMLS CUI [1]
C1521902
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Similar models

Adverse Event

1 forms
  1. StudyEvent: ODM
    1. Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ADVERSE EVENTS (AE)
C0877248 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Diagnosis; Symptoms
Item
Event
text
C0011900 (UMLS CUI [1])
C1457887 (UMLS CUI [2])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1])
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
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 (5)
end date and time
Item
When resolved/ recovered, provide end date and time
datetime
C2826793 (UMLS CUI [1])
end date and time
Item
When resolved/ recovered with sequelae, provide end date and time
datetime
C2826793 (UMLS CUI [1])
date and time of death
Item
If Fatal, record date and time of death
datetime
C3899439 (UMLS CUI [1])
Item
Frequency
integer
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
Single  (1)
CL Item
lntermillent (2)
Item
Maximum Intensity
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity
Code List
Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not applicable (X)
Item
Action taken with lnvestigational Product(s) as a result of the AE
text
C1704758 (UMLS CUI [1])
Action taken with lnvestigational Product
Code List
Action taken with lnvestigational 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 (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal by Subject; Non-serious Adverse Event
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Withdrawal by Subject; Non-serious Adverse Event
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does this Adverse Event meet the definition of serious?
text
C1519255 (UMLS CUI [1])
Withdrawal by Subject; Non-serious Adverse Event
Code List
Does this Adverse Event meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
Item
Yes, check all that apply
text
C1519255 (UMLS CUI [1])
serious adverse event
Code List
Yes, check all that apply
CL Item
Results in death (A)
C0011065 (UMLS CUI-1)
(Comment:en)
CL Item
Is life-threatening  (B)
C1517874 (UMLS CUI-1)
(Comment:en)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
C0019993 (UMLS CUI-1)
(Comment:en)
CL Item
Results in disability/incapacity  (D)
C0231170 (UMLS CUI-1)
(Comment:en)
CL Item
Congenital anomaly/birth defect  (E)
C0000768 (UMLS CUI-1)
(Comment:en)
CL Item
Other (F)
C0205394 (UMLS CUI-1)
(Comment:en)
specify
Item
Other, specify
text
C1521902 (UMLS CUI [1])
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