ID

26029

Beschrijving

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Anaphylaxis diagnosis - Repeating form (Scheduled visits)

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Versies (4)
  1. 04-10-17 04-10-17 -
  2. 16-10-17 16-10-17 -
  3. 23-10-17 23-10-17 -
  4. 01-01-18 01-01-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Anaphylaxis diagnosis Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

Engels

Anaphylaxis diagnosis Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren  
Anaphylaxis diagnosis
Beschrijving

Anaphylaxis diagnosis

1. Event number
Beschrijving

[read-only]

Datatype

text

2. Event
Beschrijving

Record the same event diagnosis, start date and time as the corresponding Non-serious Adverse Event or Serious Adverse Event form. If reaction is to a known or likely allergen, specify the allergen in the diagnosis

Datatype

text

3. Start Date
Beschrijving

Start Date

Datatype

date

3. Start Time
Beschrijving

Start Time

Datatype

time

4. Event type
Beschrijving

Event type

Datatype

text

If Type A, did the subject meet the following criteria: Reduced BP (systolic BP of less than 90 mmHg or greater than 30% decrease from that person's baseline)
Beschrijving

(if yes, subject meets diagnostic criteria for anaphylaxis)

Datatype

boolean

If Type A, did the subject meet the following criteria: Exposure-to-reaction time
Beschrijving

(if yes, subject meets diagnostic criteria for anaphylaxis)

Datatype

integer

If Type B, did the subject meet the following criteria: Involvement of the skin-mucosal tissue (e.g., generalised hives, itch-flush, swollen lips-tongue-uvula)
Beschrijving

(if yes to 2 or more, subject meets diagnostic criteria for anaphylaxis)

Datatype

boolean

If Type B, did the subject meet the following criteria: Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)
Beschrijving

(if yes to 2 or more, subject meets diagnostic criteria for anaphylaxis)

Datatype

boolean

If Type B, did the subject meet the following criteria: Reduced BP or associated symptoms (e.g., hypotonia [collapse], syncope, incontinence)
Beschrijving

(if yes to 2 or more, subject meets diagnostic criteria for anaphylaxis)

Datatype

boolean

If Type B, did the subject meet the following criteria: Persistent gastrointestinal symptoms (e.g., crampy abdominal pain, vomiting)
Beschrijving

(if yes to 2 or more, subject meets diagnostic criteria for anaphylaxis)

Datatype

boolean

If Type B, did the subject meet the following criteria: Exposure-to-reaction time
Beschrijving

(if yes to 2 or more, subject meets diagnostic criteria for anaphylaxis)

Datatype

integer

If reaction was not related to an allergen, did the subject meet the following criteria: Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalised hives, pruritis or flushing, swollen lips-tongueuvula)
Beschrijving

(if yes to acute onset of illness, AND 1 or more questions below, subject meets diagnostic criteria for anaphylaxis)

Datatype

boolean

If reaction was not related to an allergen, did the subject meet the following criteria: Reduced blood pressure (BP) or associated symptoms of end-organ dysfunction (e.g., hypotonia [collapse], syncope, incontinence)
Beschrijving

(if yes to acute onset of illness, AND 1 or more questions below, subject meets diagnostic criteria for anaphylaxis)

Datatype

boolean

If reaction was not related to an allergen, did the subject meet the following criteria: Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow (PEF), hypoxemia)
Beschrijving

(if yes to acute onset of illness, AND 1 or more questions below, subject meets diagnostic criteria for anaphylaxis)

Datatype

boolean

5. Did this event meet diagnostic criteria for anaphylaxis?
Beschrijving

If yes, complete the Hypersensitivity Reaction Record

Datatype

boolean

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Similar models

Anaphylaxis diagnosis Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Anaphylaxis diagnosis
Event number
Item
1. Event number
text
Event
Item
2. Event
text
Start Date
Item
3. Start Date
date
Start Time
Item
3. Start Time
time
Item
4. Event type
text
Event type
Code List
4. Event type
CL Item
Type A: Reaction occurred rapidly after exposure to known allergen for this subject (minutes to several hours) (G)
CL Item
Type B: Reaction occurred rapidly after exposure to likely allergen for this subject (minutes to several hours) (H)
CL Item
Reaction was not related to an allergen for this subject (I)
Reduced blood pressure
Item
If Type A, did the subject meet the following criteria: Reduced BP (systolic BP of less than 90 mmHg or greater than 30% decrease from that person's baseline)
boolean
Item
If Type A, did the subject meet the following criteria: Exposure-to-reaction time
integer
Exposure-to-reaction time
Code List
If Type A, did the subject meet the following criteria: Exposure-to-reaction time
CL Item
<30 minutes (1)
CL Item
30-60 minutes (2)
CL Item
1-3 hours (3)
CL Item
>3 hours (4)
Involvement of the skin-mucosal tissue
Item
If Type B, did the subject meet the following criteria: Involvement of the skin-mucosal tissue (e.g., generalised hives, itch-flush, swollen lips-tongue-uvula)
boolean
Respiratory compromise Type B
Item
If Type B, did the subject meet the following criteria: Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)
boolean
Reduced BP or associated symptoms
Item
If Type B, did the subject meet the following criteria: Reduced BP or associated symptoms (e.g., hypotonia [collapse], syncope, incontinence)
boolean
Persistent gastrointestinal symptoms
Item
If Type B, did the subject meet the following criteria: Persistent gastrointestinal symptoms (e.g., crampy abdominal pain, vomiting)
boolean
Item
If Type B, did the subject meet the following criteria: Exposure-to-reaction time
integer
Exposure-to-reaction time
Code List
If Type B, did the subject meet the following criteria: Exposure-to-reaction time
CL Item
<30 minutes (1)
CL Item
30-60 minutes (2)
CL Item
1-3 hours (3)
CL Item
>3 hours (4)
Acute onset of an illness
Item
If reaction was not related to an allergen, did the subject meet the following criteria: Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalised hives, pruritis or flushing, swollen lips-tongueuvula)
boolean
Reduced BP or associated symptoms of end-organ dysfunction
Item
If reaction was not related to an allergen, did the subject meet the following criteria: Reduced blood pressure (BP) or associated symptoms of end-organ dysfunction (e.g., hypotonia [collapse], syncope, incontinence)
boolean
Respiratory compromise
Item
If reaction was not related to an allergen, did the subject meet the following criteria: Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow (PEF), hypoxemia)
boolean
diagnostic criteria for anaphylaxis met
Item
5. Did this event meet diagnostic criteria for anaphylaxis?
boolean
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