ID

28273

Description

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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Versions (4)
  1. 04/10/2017 04/10/2017 -
  2. 16/10/2017 16/10/2017 -
  3. 23/10/2017 23/10/2017 -
  4. 01/01/2018 01/01/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

1 janvier 2018

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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

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Anaphylaxis diagnosis Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires  
Anaphylaxis diagnosis
Description

Anaphylaxis diagnosis

1. Event number
Description

[read-only]

Type de données

text

Alias
UMLS CUI [1]
C2826275
2. Event
Description

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

Type de données

text

Alias
UMLS CUI [1]
C0877248
3. Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1]
C0808070
3. Start Time
Description

Start Time

Type de données

time

Alias
UMLS CUI [1]
C1301880
4. Event type
Description

Event type

Type de données

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)
Description

(if yes, subject meets diagnostic criteria for anaphylaxis)

Type de données

boolean

Alias
UMLS CUI [1]
C1271104
If Type A, did the subject meet the following criteria: Exposure-to-reaction time
Description

(if yes, subject meets diagnostic criteria for anaphylaxis)

Type de données

integer

Alias
UMLS CUI [1]
C0332157
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)
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0037267
If Type B, did the subject meet the following criteria: Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C4228652
If Type B, did the subject meet the following criteria: Reduced BP or associated symptoms (e.g., hypotonia [collapse], syncope, incontinence)
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0232107
If Type B, did the subject meet the following criteria: Persistent gastrointestinal symptoms (e.g., crampy abdominal pain, vomiting)
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0426576
If Type B, did the subject meet the following criteria: Exposure-to-reaction time
Description

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

Type de données

integer

Alias
UMLS CUI [1]
C0332157
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)
Description

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

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0277793
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)
Description

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

Type de données

boolean

Alias
UMLS CUI [1,1]
C0342953
UMLS CUI [1,2]
C0232107
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)
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C4228652
5. Did this event meet diagnostic criteria for anaphylaxis?
Description

If yes, complete the Hypersensitivity Reaction Record

Type de données

boolean

Alias
UMLS CUI [1]
C0002792
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Similar models

Anaphylaxis diagnosis Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Anaphylaxis diagnosis
Event number
Item
1. Event number
text
C2826275 (UMLS CUI [1])
Event
Item
2. Event
text
C0877248 (UMLS CUI [1])
Start Date
Item
3. Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
3. Start Time
time
C1301880 (UMLS CUI [1])
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
C1271104 (UMLS CUI [1])
Item
If Type A, did the subject meet the following criteria: Exposure-to-reaction time
integer
C0332157 (UMLS CUI [1])
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
C0037267 (UMLS CUI [1])
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
C4228652 (UMLS CUI [1])
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
C0232107 (UMLS CUI [1])
Persistent gastrointestinal symptoms
Item
If Type B, did the subject meet the following criteria: Persistent gastrointestinal symptoms (e.g., crampy abdominal pain, vomiting)
boolean
C0426576 (UMLS CUI [1])
Item
If Type B, did the subject meet the following criteria: Exposure-to-reaction time
integer
C0332157 (UMLS CUI [1])
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
C0011008 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
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
C0342953 (UMLS CUI [1,1])
C0232107 (UMLS CUI [1,2])
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
C4228652 (UMLS CUI [1])
diagnostic criteria for anaphylaxis met
Item
5. Did this event meet diagnostic criteria for anaphylaxis?
boolean
C0002792 (UMLS CUI [1])
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