ID

25026

Descripción

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

Palabras clave

Versiones (1)
  1. 24/8/17 24/8/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

24 de agosto de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

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

1 formularios  
Header
Descripción

Header

Alias
UMLS CUI-1
C1320722
Protocol
Descripción

Protocol

Tipo de datos

text

Alias
UMLS CUI [1]
C1507394
Activity
Descripción

Activity

Tipo de datos

text

Alias
UMLS CUI [1]
C1512346
Subject number
Descripción

Subject number

Tipo de datos

text

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

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 ?
Descripción

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.

Tipo de datos

boolean

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

Temperature

Alias
UMLS CUI-1
C0005903
GENERAL SYMPTOMS
Descripción

General Symptoms

Tipo de datos

boolean

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

Axillary temperature

Tipo de datos

boolean

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

Oral temperature

Tipo de datos

boolean

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

Rectal temperature

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0489749
Temperature Day 0
Descripción

Temperature Day 0

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2826301
°C
Not taken
Descripción

Temperature Day 0 not taken

Tipo de datos

boolean

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

Temperature Day 1

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1442449
°C
Not taken
Descripción

Temperature Day 1 not taken

Tipo de datos

boolean

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

Temperature Day 2

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842676
°C
Not taken
Descripción

Temperature Day 2 not taken

Tipo de datos

boolean

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

Temperature Day 3

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842675
°C
Not taken
Descripción

Temperature Day 3 not taken

Tipo de datos

boolean

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

Corrective therapy : if Yes, record in the Medication Section

Tipo de datos

boolean

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

Relation

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
Headache
Descripción

Headache

Alias
UMLS CUI-1
C0018681
GENERAL SYMPTOMS
Descripción

General symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Corrective therapy : if Yes, record in the Medication Section

Tipo de datos

boolean

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

Relation

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
Malaise
Descripción

Malaise

Alias
UMLS CUI-1
C0231218
GENERAL SYMPTOMS
Descripción

General symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Corrective therapy : if Yes, record in the Medication Section

Tipo de datos

boolean

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

Relation

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
Fatigue
Descripción

Fatigue

Alias
UMLS CUI-1
C0015672
GENERAL SYMPTOMS
Descripción

General symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Corrective therapy : if Yes, record in the Medication Section

Tipo de datos

boolean

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

Relation

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
Nausea
Descripción

Nausea

Alias
UMLS CUI-1
C0027497
GENERAL SYMPTOMS
Descripción

General symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Corrective therapy : if Yes, record in the Medication Section

Tipo de datos

boolean

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

Relation

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
Vomiting
Descripción

Vomiting

Alias
UMLS CUI-1
C0042963
GENERAL SYMPTOMS
Descripción

General symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0159028
Intensity Day 0
Descripción

Intensity Day 0

Tipo de datos

integer

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

Intensity Day 1

Tipo de datos

integer

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

Intensity Day 2

Tipo de datos

integer

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

Intensity Day 3

Tipo de datos

integer

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

Corrective therapy : if Yes, record in the Medication Section

Tipo de datos

boolean

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

Relation

Tipo de datos

text

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

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
Seriousness of symptoms
Descripción

Seriousness of symptoms

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

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

Tipo de datos

boolean

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

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.
Descripción

Complete Adverse Experience Section

Tipo de datos

text

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Descripción

day/month/year

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Descripción

Signature

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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