ID

41483

Beschreibung

Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Non-serious adverse event) is to be filled out during the study.

Stichworte

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  1. 25.10.20 25.10.20 -
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GlaxoSmithKline

Hochgeladen am

25. Oktober 2020

DOI

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Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

Englisch

Non-serious adverse event

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Sequence Number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Date of assessment
Beschreibung

Date of assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Subject identification number
Beschreibung

Subject identification number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Non-serious adverse event
Beschreibung

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
Event Diagnosis only (if known) otherwise Sign/Symptom
Beschreibung

Event Diagnosis or Sign/Symptom of Non-Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C3540840
Modified term
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C0871468
MeDRA lower level term code
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start Date
Beschreibung

Start time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Outcome
Beschreibung

Outcome Non-Serious Adverse Event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
If recovered/resolved, provide End Date
Beschreibung

Outcome: Non-Serious Adverse Event recovered/resolved, End Date

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C1518404
If recovered/resolved with sequelae, provide End Date
Beschreibung

Outcome: Non-Serious Adverse Event recovered/resolved with sequelae, end date

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C1709862
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0806020
Frequency
Beschreibung

[hidden]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Record maximum intensity throughout duration of event
Beschreibung

Optional item: This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Record intensity at the onset of the event.
Beschreibung

Conditional item: Conditional on the use of the Intensity Change section. If the section is not used then the item must be hidden. This item may be hidden if either the Grade/Grade or Intensity at onset of event item has been used. [hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0518690
Record maximum grade throughout duration of event.
Beschreibung

Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional. [hidden]

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Record grade at the onset of the event
Beschreibung

Conditional item: Conditional on using the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional. [hidden]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1518404
Record maximum grade or intensity throughout duration of event
Beschreibung

Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional. [hidden]

Datentyp

text

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
Record grade or intensity at the onset of the event
Beschreibung

Conditional item: Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional. [hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1518404
UMLS CUI [2,1]
C0441800
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C1518404
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action Taken with Investigational Product(s) as a Result of the NSAE

Datentyp

text

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

Subject withdrawal due to NSAE

Datentyp

text

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? Use best judgement at initial entry. May be amended when additional information becomes available.
Beschreibung

Relations investigational product - NSAE

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of AE if < 24 hours
Beschreibung

If AE start and end time are used this item must be hidden. Record as xx Hr(s)(0<=n<=23) xx Min(s) (0<=n<=59) [hidden]

Datentyp

durationDatetime

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to onset since last dose
Beschreibung

This item is optional. Record as xx Hr(s) xx Min(s) (0<=n<=59) [hidden]

Datentyp

durationDatetime

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1518404
UMLS CUI [1,4]
C3174092
UMLS CUI [1,5]
C1517741
Intensity Changes Entry
Beschreibung

Intensity Changes Entry

Alias
UMLS CUI-1
C0518690
UMLS CUI-2
C0392747
UMLS CUI-3
C1518404
NSAE-Sequence-Number
Beschreibung

This item was not in the original document

Datentyp

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1518404
Start Date and Time of event segment
Beschreibung

If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0808070
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C1301880
Intensity of event segment
Beschreibung

Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
Grade of event segment
Beschreibung

Optional item: This item may be hidden if either the Intensity of event segment or Grade or Intensity of event segment has been used and item not included in the section. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
Grade or Intensity of event segment
Beschreibung

Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment has been used and item not included in the section. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C0441800
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Ähnliche Modelle

Non-serious adverse event

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Subject identification number
Item
Subject identification number
text
C2348585 (UMLS CUI [1])
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Event Diagnosis or Sign/Symptom of Non-Serious Adverse Event
Item
Event Diagnosis only (if known) otherwise Sign/Symptom
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
MeDRA lower level term code
Item
MeDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start Date Non-Serious Adverse Event
Item
Start Date
partialDatetime
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome/End Date
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
Outcome: Non-Serious Adverse Event recovered/resolved, End Date
Item
If recovered/resolved, provide End Date
partialDatetime
C0806020 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Outcome: Non-Serious Adverse Event recovered/resolved with sequelae, end date
Item
If recovered/resolved with sequelae, provide End Date
partialDatetime
C1709862 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Frequency
integer
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Record maximum intensity throughout duration of event
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum intensity
Code List
Record maximum intensity throughout duration of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Record intensity at the onset of the event.
text
C0332162 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Intensity at onset of event
Code List
Record intensity at the onset of the event.
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Record maximum grade throughout duration of event.
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Grade
Code List
Record maximum grade throughout duration of event.
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)
Item
Record grade at the onset of the event
integer
C0441800 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Grade at onset of event
Code List
Record grade at the onset of the event
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)
Item
Record maximum grade or intensity throughout duration of event
text
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])
Maximum Grade or Intensity
Code List
Record maximum grade or intensity throughout duration of event
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
Record grade or intensity at the onset of the event
text
C0518690 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C1518404 (UMLS CUI [2,3])
Grade or Intensity at onset of event
Code List
Record grade or intensity at the onset of the event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Sever 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 AE
text
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 (X)
Item
Did the subject withdraw from study as a result of the AE
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Subject withdrawal due to AE
Code List
Did the subject withdraw from study as a result of the 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? Use best judgement at initial entry. May be amended when additional information becomes available.
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relations investigational product - AE
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product? Use best judgement at initial entry. May be amended when additional information becomes available.
CL Item
Yes (Y)
CL Item
No (N)
Duration of NSAE
Item
Duration of AE if < 24 hours
durationDatetime
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to onset of Non-Serious Adverse Event since last dose
Item
Time to onset since last dose
durationDatetime
C1272706 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
Item Group
Intensity Changes Entry
C0518690 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
C1518404 (UMLS CUI-3)
NSAE-Sequence-Number
Item
NSAE-Sequence-Number
text
C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date and Time of Non-Serious Adverse Event segment
Item
Start Date and Time of event segment
datetime
C1518404 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
Item
Intensity of event segment
integer
C1518404 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Intensity of event segment
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
integer
C1518404 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Grade of event segment
Code List
Grade of event segment
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)
Item
Grade or Intensity of event segment
integer
C1518404 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
Grade or Intensity of event segment
Code List
Grade or Intensity of event segment
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Sever or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
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