ID

35864

Beschreibung

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Diary card form. It has to be filled in by subject.

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Stichworte

Versionen (3)
  1. 26.03.19 26.03.19 -
  2. 26.03.19 26.03.19 -
  3. 29.03.19 29.03.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

29. März 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

Englisch

Diary card

1 Formulare  
  1. StudyEvent: ODM
    1. Diary card
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Dose type
Beschreibung

Dose type

Datentyp

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0332307
Please do not forget to bring back the diary card on:
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0011008
In case of hospitalization, please inform
Beschreibung

Contact person, Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0337611
UMLS CUI [1,2]
C1547383
Contact person, Telephone number
Beschreibung

Contact person, Telephone number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0337611
UMLS CUI [1,2]
C1515258
Local symptoms (at injection site)
Beschreibung

Local symptoms (at injection site)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C2700396
Day 0 = date of vaccination
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Local symptoms
Beschreibung

Local symptoms

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Day after Vaccination
Beschreibung

Day after Vaccination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Size of symptom
Beschreibung

Fill in for each symptom (redness and swelling/induration) for every day.

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0518690
mm
Intensity of Pain
Beschreibung

Fill in for every day. Pain at injection site: 0: Absent 1: Pain on touching the site, not otherwise. 2: Pain on moving the limb which interferes with normal activities or requires repeated use of pain relievers 3: Significant pain at rest; prevents normal activities as as assessed by inability to attend/do work or school.

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Ongoing after Day 6?
Beschreibung

Symptom ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
If symptom is ongoing after Day 6, please specify the date of the last day of symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Other local symptoms (From Visit "Day 0" to Visit "Day 7")
Beschreibung

Other local symptoms (From Visit "Day 0" to Visit "Day 7")

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Other local symptoms, Description - please specify side(s) and site(s)
Beschreibung

Other local symptoms, description

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0441987
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1457887
UMLS CUI [2,4]
C0205276
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C1457887
UMLS CUI [3,4]
C0205276
Other local symptoms, Intensity
Beschreibung

Definition: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an AE would, for example, prevent attendance at work or school and would necessitate the administration of prescription (symptomatic or specific) therapy.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0518690
Start date of other local symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
End date of other local symptom
Beschreibung

day month year. or check box below, if continuing

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Check if other symptom continuing
Beschreibung

Other symptom ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0549178
Medically attended Visit
Beschreibung

Medically attended Visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medication (From Visit "Day 0" to Visit "Day 7")
Beschreibung

Medication (From Visit "Day 0" to Visit "Day 7")

Alias
UMLS CUI-1
C0013227
Trade / Generic Name of medication
Beschreibung

Trade / Generic Name of medication

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013227
Reason for medication
Beschreibung

Indication of medication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1]
C2826638
Start date of medication
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date of medication
Beschreibung

day month year. or check box below, if continuing.

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Check if medication continuing
Beschreibung

Medication ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
General Symptoms
Beschreibung

General Symptoms

Alias
UMLS CUI-1
C0159028
Day 0 = date of vaccination
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
General symptom
Beschreibung

Please give information for each symptom and day mentioned.

Datentyp

integer

Alias
UMLS CUI [1]
C0159028
Day after Vaccination
Beschreibung

Please give information for each symptom and day mentioned.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
For Temperature, please note the route of measurement.
Beschreibung

Body temperature, route of measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Body temperature
Beschreibung

Please record the temperature every day in the evening. If temperature has been taken more than once a day, please report the highest value for the day.

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of symptom
Beschreibung

Definition of intensity: 0: None 1: No effect on normal activities 2: Some interference with normal everyday activities or (for headache, joint or muscle pain) requires repeated use of pain relievers 3: Prevents normal everyday activities as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Ongoing after Day 6?
Beschreibung

Symptom ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
If symptom is ongoing after Day 6, please specify the date of the last day of symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Other general symptoms (From Visit "Day 0" to Visit "Day 7")
Beschreibung

Other general symptoms (From Visit "Day 0" to Visit "Day 7")

Alias
UMLS CUI-1
C0029625
Other general symptoms, Description - please specify side(s) and site(s)
Beschreibung

Other general symptoms, description

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0159028
Other general symptoms, Intensity
Beschreibung

Definition: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an AE would, for example, prevent attendance at work or school and would necessitate the administration of prescription (symptomatic or specific) therapy.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0159028
UMLS CUI [2]
C0518690
Start date of other general symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0159028
End date of other general symptom
Beschreibung

day month year. or check box below, if continuing.

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0159028
Check if other general symptom continuing
Beschreibung

Other general symptom ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Medically attended Visit
Beschreibung

Medically attended Visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Adverse event form - symptoms
Beschreibung

Adverse event form - symptoms

Alias
UMLS CUI-1
C0877248
Adverse event symptoms, Description - please give details below End date or check box if continuing and specify side(s) and site(s) for local symptoms
Beschreibung

Adverse event symptoms, description

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
UMLS CUI [2,1]
C0441987
UMLS CUI [2,2]
C1457887
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C1457887
Other general symptoms, Intensity
Beschreibung

Definition: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an AE would, for example, prevent attendance at work or school and would necessitate the administration of prescription (symptomatic or specific) therapy.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0518690
Start date of adverse event symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
End date of adverse event symptom
Beschreibung

day month year. or check box below, if continuing.

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
Check if symptom continuing
Beschreibung

Symptom ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
Medically attended Visit
Beschreibung

Medically attended Visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Adverse event - Medication
Beschreibung

Adverse event - Medication

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0013227
Trade / Generic Name of medication
Beschreibung

Trade / Generic Name of medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2360065
UMLS CUI [1,3]
C0013227
Reason for medication
Beschreibung

Indication of medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1]
C2826638
Start date of medication
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date of medication
Beschreibung

day month year. or check box below, if continuing.

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Check if medication continuing
Beschreibung

Medication ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
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Ähnliche Modelle

Diary card

1 Formulare
  1. StudyEvent: ODM
    1. Diary card
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Dose type
integer
C3174092 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Dose type
Code List
Dose type
CL Item
Dose 1 (1)
CL Item
Dose 2 (2)
Date of diary card return
Item
Please do not forget to bring back the diary card on:
date
C3890583 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Contact person, Name
Item
In case of hospitalization, please inform
text
C0337611 (UMLS CUI [1,1])
C1547383 (UMLS CUI [1,2])
Contact person, Telephone number
Item
Contact person, Telephone number
integer
C0337611 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Item Group
Local symptoms (at injection site)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms
Code List
Local symptoms
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Item
Day after Vaccination
integer
C0439228 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Day of symptom duration
Code List
Day after Vaccination
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3  (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Size of symptom
Item
Size of symptom
integer
C0456389 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Item
Intensity of Pain
integer
C1320357 (UMLS CUI [1])
Intensity of Pain
Code List
Intensity of Pain
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Ongoing after Day 6?
text
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Symptom ongoing
Code List
Ongoing after Day 6?
CL Item
Yes (Y)
CL Item
No (N)
Date of last Day of Symptoms
Item
If symptom is ongoing after Day 6, please specify the date of the last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other local symptoms (From Visit "Day 0" to Visit "Day 7")
C0205394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Other local symptoms, description
Item
Other local symptoms, Description - please specify side(s) and site(s)
text
C0205394 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0441987 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0205276 (UMLS CUI [2,4])
C1515974 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C1457887 (UMLS CUI [3,3])
C0205276 (UMLS CUI [3,4])
Item
Other local symptoms, Intensity
integer
C0205394 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0518690 (UMLS CUI [2])
Other local symptoms, description
Code List
Other local symptoms, Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Start date of other local symptom
Item
Start date of other local symptom
date
C0808070 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
End date of other local symptom
Item
End date of other local symptom
date
C0806020 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Other symptom ongoing
Item
Check if other symptom continuing
boolean
C0205394 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item
Medically attended Visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended Visit
Code List
Medically attended Visit
CL Item
Yes  (Y)
CL Item
No (N)
Item Group
Medication (From Visit "Day 0" to Visit "Day 7")
C0013227 (UMLS CUI-1)
Trade / Generic Name of medication
Item
Trade / Generic Name of medication
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Indication of medication
Item
Reason for medication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2826638 (UMLS CUI [1])
Start date of medication
Item
Start date of medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date of medication
Item
End date of medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication ongoing
Item
Check if medication continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
General symptom
integer
C0159028 (UMLS CUI [1])
General symptom
Code List
General symptom
CL Item
Temperature (1)
CL Item
Fatigue (2)
CL Item
Headache (3)
CL Item
Joint pain (4)
CL Item
Muscle aches (5)
CL Item
Shivering (6)
CL Item
Sweating increase (7)
Item
Day after Vaccination
integer
C0439228 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Day of symptom duration
Code List
Day after Vaccination
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3  (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Item
For Temperature, please note the route of measurement.
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Body temperature, route of measurement
Code List
For Temperature, please note the route of measurement.
CL Item
Axillary (A)
CL Item
Oral (O)
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
Item
Intensity of symptom
integer
C0518690 (UMLS CUI [1])
Intensity of symptom
Code List
Intensity of symptom
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Ongoing after Day 6?
text
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Symptom ongoing
Code List
Ongoing after Day 6?
CL Item
Yes (Y)
CL Item
No (N)
Date of last Day of Symptoms
Item
If symptom is ongoing after Day 6, please specify the date of the last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Other general symptoms (From Visit "Day 0" to Visit "Day 7")
C0029625 (UMLS CUI-1)
Other general symptoms, description
Item
Other general symptoms, Description - please specify side(s) and site(s)
text
C0205394 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Item
Other general symptoms, Intensity
integer
C0205394 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2])
Other local symptoms, description
Code List
Other general symptoms, Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Start date of other general symptom
Item
Start date of other general symptom
date
C0808070 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
End date of other general symptom
Item
End date of other general symptom
date
C0806020 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Other general symptom ongoing
Item
Check if other general symptom continuing
boolean
C0205394 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item
Medically attended Visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended Visit
Code List
Medically attended Visit
CL Item
Yes  (Y)
CL Item
No (N)
Item Group
Adverse event form - symptoms
C0877248 (UMLS CUI-1)
Adverse event symptoms, description
Item
Adverse event symptoms, Description - please give details below End date or check box if continuing and specify side(s) and site(s) for local symptoms
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0441987 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
Item
Other general symptoms, Intensity
integer
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2])
Other local symptoms, description
Code List
Other general symptoms, Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Start date of adverse event symptom
Item
Start date of adverse event symptom
date
C0808070 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
End date of adverse event symptom
Item
End date of adverse event symptom
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Symptom ongoing
Item
Check if symptom continuing
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Medically attended Visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended Visit
Code List
Medically attended Visit
CL Item
Yes  (Y)
CL Item
No (N)
Item Group
Adverse event - Medication
C0877248 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Trade / Generic Name of medication
Item
Trade / Generic Name of medication
text
C0877248 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Indication of medication
Item
Reason for medication
text
C0877248 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Total daily dose
Item
Total daily dose
text
C2826638 (UMLS CUI [1])
Start date of medication
Item
Start date of medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date of medication
Item
End date of medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication ongoing
Item
Check if medication continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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