ID

25026

Beschrijving

Visit 4 Dose 2 General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Trefwoorden

Versies (1)
  1. 24-08-17 24-08-17 -
Houder van rechten

GlaxoSmithKline

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24 augustus 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Visit 4 Dose 2 General Symptoms Biologicals HepA/HepB vaccine 208127/125

Engels

Visit 4 Dose 2 General Symptoms Biologicals HepA/HepB vaccine 208127/125

1 Formulieren  
Header
Beschrijving

Header

Alias
UMLS CUI-1
C1320722
Protocol
Beschrijving

Protocol

Datatype

text

Alias
UMLS CUI [1]
C1507394
Activity
Beschrijving

Activity

Datatype

text

Alias
UMLS CUI [1]
C1512346
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS
Beschrijving

SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
IV. Has the subject experienced any general solicited signs or symptoms since vaccine administration ?
Beschrijving

if No: Please, go to paragraph V. if Yes: Please tick a No/Yes box for each symptom. If any experience was observed, please fill in the complete line.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C2368628
Temperature
Beschrijving

Temperature

Alias
UMLS CUI-1
C0005903
GENERAL SYMPTOMS
Beschrijving

General Symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C0159028
Axillary ≥ 37,5°C
Beschrijving

Axillary temperature

Datatype

boolean

Alias
UMLS CUI [1]
C1531924
Oral ≥ 37,5°C
Beschrijving

Oral temperature

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
Rectal ≥ 38°C
Beschrijving

Rectal temperature

Datatype

boolean

Alias
UMLS CUI [1]
C0489749
Temperature Day 0
Beschrijving

Temperature Day 0

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2826301
°C
Not taken
Beschrijving

Temperature Day 0 not taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826301
UMLS CUI [1,2]
C0437722
Temperature Day 1
Beschrijving

Temperature Day 1

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1442449
°C
Not taken
Beschrijving

Temperature Day 1 not taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C1442449
UMLS CUI [1,2]
C0437722
Temperature Day 2
Beschrijving

Temperature Day 2

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842676
°C
Not taken
Beschrijving

Temperature Day 2 not taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C3842676
UMLS CUI [1,2]
C0437722
Temperature Day 3
Beschrijving

Temperature Day 3

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842675
°C
Not taken
Beschrijving

Temperature Day 3 not taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C3842675
UMLS CUI [1,2]
C0437722
Corrective therapy ?
Beschrijving

Corrective therapy : if Yes, record in the Medication Section

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Beschrijving

Relation

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschrijving

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Headache
Beschrijving

Headache

Alias
UMLS CUI-1
C0018681
GENERAL SYMPTOMS
Beschrijving

General symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Beschrijving

Intensity Day 0

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beschrijving

Intensity Day 1

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beschrijving

Intensity Day 2

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beschrijving

Intensity Day 3

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Beschrijving

Corrective therapy : if Yes, record in the Medication Section

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Beschrijving

Relation

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschrijving

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Malaise
Beschrijving

Malaise

Alias
UMLS CUI-1
C0231218
GENERAL SYMPTOMS
Beschrijving

General symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Beschrijving

Intensity Day 0

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beschrijving

Intensity Day 1

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beschrijving

Intensity Day 2

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beschrijving

Intensity Day 3

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Beschrijving

Corrective therapy : if Yes, record in the Medication Section

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Beschrijving

Relation

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschrijving

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Fatigue
Beschrijving

Fatigue

Alias
UMLS CUI-1
C0015672
GENERAL SYMPTOMS
Beschrijving

General symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Beschrijving

Intensity Day 0

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beschrijving

Intensity Day 1

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beschrijving

Intensity Day 2

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beschrijving

Intensity Day 3

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Beschrijving

Corrective therapy : if Yes, record in the Medication Section

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Beschrijving

Relation

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschrijving

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Nausea
Beschrijving

Nausea

Alias
UMLS CUI-1
C0027497
GENERAL SYMPTOMS
Beschrijving

General symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Beschrijving

Intensity Day 0

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beschrijving

Intensity Day 1

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beschrijving

Intensity Day 2

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beschrijving

Intensity Day 3

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Beschrijving

Corrective therapy : if Yes, record in the Medication Section

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Beschrijving

Relation

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschrijving

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Vomiting
Beschrijving

Vomiting

Alias
UMLS CUI-1
C0042963
GENERAL SYMPTOMS
Beschrijving

General symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Beschrijving

Intensity Day 0

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Beschrijving

Intensity Day 1

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Beschrijving

Intensity Day 2

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Beschrijving

Intensity Day 3

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Beschrijving

Corrective therapy : if Yes, record in the Medication Section

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Relation
Beschrijving

Relation

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschrijving

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Seriousness of symptoms
Beschrijving

Seriousness of symptoms

Alias
UMLS CUI-1
C0871902
UMLS CUI-2
C1457887
Do you consider any of these adverse experiences to be serious ?
Beschrijving

if Yes: Please report experience to SmithKline Beecham monitor by telephone, telex or telefax withitl 24 hours (see protocol) and complete the SAEF form.

Datatype

boolean

Alias
UMLS CUI [1]
C1710056
V. OTHER GENERAL SYMPTOMS
Beschrijving

V. OTHER GENERAL SYMPTOMS

Alias
UMLS CUI-1
C0029625
If any general symptom other than those listed above occurred, please complete the Adverse Experience Section.
Beschrijving

Complete Adverse Experience Section

Datatype

text

Alias
UMLS CUI [1,1]
C0029625
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1521800
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Beschrijving

day/month/year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 4 Dose 2 General Symptoms Biologicals HepA/HepB vaccine 208127/125

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
SOLICITED ADVERSE EXPERIENCES - GENERAL SYMPTOMS
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Signs or symptoms since vaccine administration
Item
IV. Has the subject experienced any general solicited signs or symptoms since vaccine administration ?
boolean
C0159028 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item Group
Temperature
C0005903 (UMLS CUI-1)
General Symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
Axillary temperature
Item
Axillary ≥ 37,5°C
boolean
C1531924 (UMLS CUI [1])
Oral temperature
Item
Oral ≥ 37,5°C
boolean
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
Rectal temperature
Item
Rectal ≥ 38°C
boolean
C0489749 (UMLS CUI [1])
Temperature Day 0
Item
Temperature Day 0
float
C0005903 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Temperature Day 0 not taken
Item
Not taken
boolean
C2826301 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Temperature Day 1
Item
Temperature Day 1
float
C0005903 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Temperature Day 1 not taken
Item
Not taken
boolean
C1442449 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Temperature Day 2
Item
Temperature Day 2
float
C0005903 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Temperature Day 2 not taken
Item
Not taken
boolean
C3842676 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Temperature Day 3
Item
Temperature Day 3
float
C0005903 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Temperature Day 3 not taken
Item
Not taken
boolean
C3842675 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relation
Code List
Relation
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Headache
C0018681 (UMLS CUI-1)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relation
Code List
Relation
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Malaise
C0231218 (UMLS CUI-1)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relation
Code List
Relation
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Fatigue
C0015672 (UMLS CUI-1)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relation
Code List
Relation
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Nausea
C0027497 (UMLS CUI-1)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relation
Code List
Relation
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Vomiting
C0042963 (UMLS CUI-1)
General symptoms
Item
GENERAL SYMPTOMS
boolean
C0159028 (UMLS CUI [1])
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Relation
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relation
Code List
Relation
CL Item
Related (R)
CL Item
Possibly related (PR)
CL Item
Probably unrelated (PU)
CL Item
Unrelated (U)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Seriousness of symptoms
C0871902 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
Seriousness of symptoms
Item
Do you consider any of these adverse experiences to be serious ?
boolean
C1710056 (UMLS CUI [1])
Item Group
V. OTHER GENERAL SYMPTOMS
C0029625 (UMLS CUI-1)
Complete Adverse Experience Section
Item
If any general symptom other than those listed above occurred, please complete the Adverse Experience Section.
text
C0029625 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1521800 (UMLS CUI [1,3])
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date
Item
Date :
date
C0011008 (UMLS CUI [1])
Signature
Item
Investigator Signature :
text
C2346576 (UMLS CUI [1])
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