ID

28747

Beschreibung

A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Stichworte

Versionen (3)
  1. 31.01.18 31.01.18 -
  2. 22.02.18 22.02.18 -
  3. 11.03.18 11.03.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

31. Januar 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder [ID 101497]

Englisch

Visit 1 (Screening)

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 1 (Screening)
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

White: Origins in the original peoples of Europe, the Middle East, Western Russia, Afghanistan, or the white racial groups of Africa Black: Origins in any of the black racial groups of Africa Asian: Origins in the original peoples of the Indian subcontinent, the Far East, Southeast Asia, or the Pacific Islands American Hispanic: Hispanics of North, Central or South American origin American Hispanic Other: People whose racial group is not represented above, or whose predominant origin cannot be determined

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Childbearing potential
Beschreibung

Childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
Contraceptive Methods
Beschreibung

Contraceptive Methods

Alias
UMLS CUI-1
C0700589
Contraceptive method
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C0700589
Other
Beschreibung

Specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205394
Psychiatric History
Beschreibung

Psychiatric History

Alias
UMLS CUI-1
C0748059
Psychiatric Condition
Beschreibung

Psychiatric Condition

Datentyp

text

Alias
UMLS CUI [1]
C0004936
Yes/No
Beschreibung

Condition in patient medical history

Datentyp

boolean

Alias
UMLS CUI [1]
C1552663
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Continuing?
Beschreibung

Continuing psychiatric condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439598
UMLS CUI [1,2]
C0004936
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Psychiatric History (cont.)
Beschreibung

Psychiatric History (cont.)

Alias
UMLS CUI-1
C0748061
UMLS CUI-2
C0205394
Are there any relevant additional psychiatric conditions not identified by the MINI but by the full Psychiatric Interview?
Beschreibung

If 'Yes' please record the full condition below

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0748061
UMLS CUI [1,2]
C0205394
Psychiatric History_Other_List
Beschreibung

Psychiatric History_Other_List

Alias
UMLS CUI-1
C0748061
UMLS CUI-2
C0205394
Specify Condition
Beschreibung

Psychiatric Condition

Datentyp

text

Alias
UMLS CUI [1]
C0004936
Specify DSM-IV code:
Beschreibung

DSM-IV code

Datentyp

text

Alias
UMLS CUI [1]
C0220952
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Continuing?
Beschreibung

Continuing psychiatric condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439598
UMLS CUI [1,2]
C0004936
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
History of Major Depression
Beschreibung

History of Major Depression

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C1269683
1. Has the subject had any prior episodes of Major Depression?
Beschreibung

If yes, continue with questions 2-4.

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
2. Month and year of first previous episode of Major Depression.
Beschreibung

Date of first previous episode of Major Depression

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0205435
3. Number of previous episodes of depressive illness in the past (do not include present episode).
Beschreibung

Number of previous episodes of depressive illness

Datentyp

integer

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C4086638
4. Has the subject received any medication for past episodes of Major Depression which was stopped more than one month prior to the screening visit?
Beschreibung

If 'Yes' please record details in the Depression Medication History panel.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1269683
Depresison medication history
Beschreibung

Depresison medication history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0013227
UMLS CUI-3
C1269683
Drug Name (trade name preferred)
Beschreibung

Record the details of any medication that the subject has received for past episodes of Major Depression. Only record medication that was stopped more than one month prior to the screening visit. Note: Medication received for Major Depression within one month prior to the screening visit should be recorded on the Prior and Concomitant Medications panel.

Datentyp

text

Alias
UMLS CUI [1]
C0013227
HAM-D 17 IVRS prompt
Beschreibung

HAM-D 17 IVRS prompt

Alias
UMLS CUI-1
C3639712
Did the subject complete the HAM-D assessment at this visit via the Interactive Voice Response System (IVRS)?
Beschreibung

----> If 'Yes', continue below ----> If 'No', the subject is not eligible to continue in this study.

Datentyp

boolean

Alias
UMLS CUI [1]
C3639712
If 'Yes', was the subject's HAM-D total score >=18 at this visit?
Beschreibung

If 'No', the subject is not eligible to continue in this study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3639712
UMLS CUI [1,2]
C0449820
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Heart Rate
Beschreibung

Vital signs should be measured after the subject has been seated for at least 5 minutes. Heart Rate will be measured for 30 seconds.

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Blood Pressure Systolic
Beschreibung

Vital signs should be measured after the subject has been seated for at least 5 minutes. Average Blood Pressure from 2 readings is recorded.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure Diastolic
Beschreibung

Vital signs should be measured after the subject has been seated for at least 5 minutes. Average Blood Pressure from 2 readings is recorded.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Physical Examination Prompt
Beschreibung

Physical Examination Prompt

Alias
UMLS CUI-1
C0031809
Was a physical examination completed for this visit?
Beschreibung

Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0031809
Were any abnormalities detected?
Beschreibung

If 'Yes', please record the appropriate details in the Current Medical Conditions panel which is the next panel.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1704258
Current Medical Conditions
Beschreibung

Current Medical Conditions

Alias
UMLS CUI-1
C3899485
Body System
Beschreibung

Record any current medical condition. Enter a separate record for each condition, selecting the appropriate body system. Psychiatric history should NOT be recorded here, but in the Psychiatric History panel. Allergic conditions should be recorded on the Allergic History panel.

Datentyp

text

Alias
UMLS CUI [1]
C0460002
Condition
Beschreibung

Record any current medical condition. Enter a separate record for each condition, selecting the appropriate body system. Psychiatric history should NOT be recorded here, but in the Psychiatric History panel. Allergic conditions should be recorded on the Allergic History panel.

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Allergic History
Beschreibung

Allergic History

Alias
UMLS CUI-1
C0020517
Medical History (past or current)
Beschreibung

Medical History

Datentyp

text

Alias
UMLS CUI [1]
C0262926
Asthma
Beschreibung

Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
Environmental Allergy
Beschreibung

ie.hayfever, seasonal rhinitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0282504
Food Allergy
Beschreibung

Food Allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0016470
Specify Food
Beschreibung

Food Allergy - Specify Food

Datentyp

text

Alias
UMLS CUI [1]
C0016452
Drug Hypersensitivity / Allergy
Beschreibung

Drug Hypersensitivity / Allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
Specify Drug
Beschreibung

Drug Hypersensitivity / Allergy - Specify Drug

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Bronchospasm
Beschreibung

Bronchospasm

Datentyp

boolean

Alias
UMLS CUI [1]
C0006266
Rash
Beschreibung

Rash

Datentyp

boolean

Alias
UMLS CUI [1]
C0015230
Urticaria
Beschreibung

Urticaria

Datentyp

boolean

Alias
UMLS CUI [1]
C0042109
Pruritis
Beschreibung

Pruritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0033774
Angioedema
Beschreibung

Angioedema

Datentyp

text

Alias
UMLS CUI [1]
C0002994
Serum Sickness
Beschreibung

ie. myalgia, fatigue

Datentyp

boolean

Alias
UMLS CUI [1]
C0036830
Stevens-Johnson Syndrome
Beschreibung

(severe rash with fever, fatigue, lymphedema)

Datentyp

boolean

Alias
UMLS CUI [1]
C0038325
Anaphylaxis
Beschreibung

Anaphylaxis

Datentyp

boolean

Alias
UMLS CUI [1]
C0002792
OTHER
Beschreibung

OTHER allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205394
Specify other:
Beschreibung

OTHER allergy - specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205394
Prior and Concomitant Medication Prompt
Beschreibung

Prior and Concomitant Medication Prompt

Alias
UMLS CUI-1
C2826257
UMLS CUI-3
C2347852
Has the subject taken any medication (including prescribed, non-prescribed and herbal) within one month of the screening visit, including those that are still ongoing?
Beschreibung

If 'Yes', please record on the Prior and Concomitant Medications panel.

Datentyp

boolean

Alias
UMLS CUI [1]
C2826257
UMLS CUI [2]
C2347852
12-lead Electrocardiogram
Beschreibung

12-lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Was the ECG trace completed at this visit?
Beschreibung

If 'Yes': Ensure the trace is sent to the Central ECG Reader. Refer to the Investigator Guidelines. Please enter the ECG result below AFTER the Central ECG Reader provides the result.

Datentyp

boolean

Alias
UMLS CUI [1]
C1623258
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Result of ECG
Beschreibung

If 'Abnormal - clinically significant', please record on the Current Medical Conditions panel.

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Laboratory tests
Beschreibung

Laboratory tests

Alias
UMLS CUI-1
C0022885
Date of blood sample
Beschreibung

Date of blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Date of urine samples
Beschreibung

Date of urine samples

Datentyp

date

Alias
UMLS CUI [1,1]
C2371162
UMLS CUI [1,2]
C0011008
After reviewing the laboratory results, are there any clinically significant abnormalities?
Beschreibung

Please answer the questions AFTER the laboratory results are back. If 'Yes' please record the appropriate details in the Current Medical Conditions panel. Saving this panel after selecting 'Yes' will take you to the Current Medical Conditions panel.

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
Did the subject have a blood alcohol level of >=15 mg/dl (0.015%) at Screening?
Beschreibung

Please answer the question AFTER the laboratory results are back. If "Yes", the subject is not eligible for the study. A positive blood alcohol level test may not be repeated

Datentyp

boolean

Alias
UMLS CUI [1]
C0202304
Result of urine drug screen?
Beschreibung

Please answer the question AFTER the laboratory results are back. If "Positive", the subject is not eligible for the study. A positive urine drug screen test may not be repeated.

Datentyp

boolean

Alias
UMLS CUI [1]
C0202274
Serum hCG
Beschreibung

Serum hCG

Alias
UMLS CUI-1
C2348195
Was a serum HCG performed?
Beschreibung

If "Yes", please record result below.

Datentyp

boolean

Alias
UMLS CUI [1]
C2348195
Sample Date
Beschreibung

Sample Date hCG

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C2348195
Result
Beschreibung

If "Positive", withdraw the subject and complete the paper Pregnancy Notification form. Also complete the End of Study Record panels

Datentyp

boolean

Alias
UMLS CUI [1]
C2348195
Eligibility Criteria and Comments
Beschreibung

Eligibility Criteria and Comments

Alias
UMLS CUI-1
C1516637
UMLS CUI-3
C0947611
Did the subject meet all of the inclusion criteria?
Beschreibung

see seperate form If 'No', check all boxes corresponding to violations of any of the Screening Visit inclusion criteria. Note that the numbering of the criteria is as in the protocol but those criteria that can only be assessed at the Screening Visit are listed. If the subject passed all of the Screening Visit inclusion and exclusion criteria, schedule the Baseline Visit for when the laboratory and ECG results are due back but no more than 14 days time.

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
Did the subject meet any of the exclusion criteria?
Beschreibung

If 'Yes', check all boxes corresponding to the Screening Visit exclusion criteria that disqualified the subject from entry. Note that the numbering of the criteria is as in the protocol but those criteria that can only be assessed at the Screening Visit are listed. If the subject passed all of the Screening Visit inclusion and exclusion criteria, schedule the Baseline Visit for when the laboratory and ECG results are due back but no more than 14 days time.

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Record any additional comments related to this visit
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Visit 1 (Screening)

1 Formulare
  1. StudyEvent: ODM
    1. Visit 1 (Screening)
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (FEMALE)
CL Item
Male (MALE)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (WHITE)
CL Item
Black (BLACK)
CL Item
Asian (ASIAN)
CL Item
American Hispanic (AMERICAN HISPANIC)
CL Item
Other (OTHER)
Childbearing potential
Item
Childbearing potential
boolean
C3831118 (UMLS CUI [1])
Item Group
Contraceptive Methods
C0700589 (UMLS CUI-1)
Item
Contraceptive method
integer
C0700589 (UMLS CUI [1])
Contraceptive method
Code List
Contraceptive method
CL Item
Oral contraceptive (1)
C0009905 (UMLS CUI-1)
(Comment:en)
CL Item
Intrauterine contraceptive device (2)
C0021900 (UMLS CUI-1)
(Comment:en)
CL Item
Depot contraceptive (implants, injectables) (3)
C0700589 (UMLS CUI-1)
C2585377 (UMLS CUI-2)
(Comment:en)
CL Item
Double barrier (condom, diaphragm) (4)
C0042241 (UMLS CUI-1)
C3873750 (UMLS CUI-3)
(Comment:en)
CL Item
Sterilisation of male partner (5)
C0024559 (UMLS CUI-1)
(Comment:en)
CL Item
Abstinence (6)
C3843422 (UMLS CUI-1)
(Comment:en)
Other contraceptive method
Item
Other
text
C0700589 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Psychiatric History
C0748059 (UMLS CUI-1)
Item
Psychiatric Condition
text
C0004936 (UMLS CUI [1])
Psychiatric Condition
Code List
Psychiatric Condition
CL Item
Major Depressive Episode (A)
C0024517 (UMLS CUI-1)
(Comment:en)
CL Item
Dysthymia (B)
C0013415 (UMLS CUI-1)
(Comment:en)
CL Item
Suicidality (C)
C0438696 (UMLS CUI-1)
(Comment:en)
CL Item
(Hypo) Manic Episode (D)
C0349208 (UMLS CUI-1)
C1396834 (UMLS CUI-3)
(Comment:en)
CL Item
Panic Disorder (E)
C0030319 (UMLS CUI-1)
(Comment:en)
CL Item
Agoraphobia (F)
C0001818 (UMLS CUI-1)
(Comment:en)
CL Item
Social Phobia (G)
C0031572 (UMLS CUI-1)
(Comment:en)
CL Item
Obsessive Compulsive Disorder (H)
C0028768 (UMLS CUI-1)
(Comment:en)
CL Item
Alcohol (Dependence/Abuse) (J)
C0085762 (UMLS CUI-1)
(Comment:en)
CL Item
Drug (Dependence/Abuse) (Non-alcohol) (K)
C1510472 (UMLS CUI-1)
(Comment:en)
CL Item
Psychotic Disorders (L)
CL Item
Anorexia Nervosa (M)
CL Item
Bulimia Nervosa (N)
CL Item
Generalised Anxiety Disorder (O)
Yes/No
Item
Yes/No
boolean
C1552663 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Continuing psychiatric condition
Item
Continuing?
boolean
C0439598 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
Psychiatric History (cont.)
C0748061 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Psychiatric History_Other
Item
Are there any relevant additional psychiatric conditions not identified by the MINI but by the full Psychiatric Interview?
boolean
C0748061 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Psychiatric History_Other_List
C0748061 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Psychiatric Condition
Item
Specify Condition
text
C0004936 (UMLS CUI [1])
DSM-IV code
Item
Specify DSM-IV code:
text
C0220952 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Continuing psychiatric condition
Item
Continuing?
boolean
C0439598 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
History of Major Depression
C0262926 (UMLS CUI-1)
C1269683 (UMLS CUI-2)
Previous episodes of Major Depression
Item
1. Has the subject had any prior episodes of Major Depression?
boolean
C1269683 (UMLS CUI [1])
Date of first previous episode of Major Depression
Item
2. Month and year of first previous episode of Major Depression.
partialDate
C0024517 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
Number of previous episodes of depressive illness
Item
3. Number of previous episodes of depressive illness in the past (do not include present episode).
integer
C0349217 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Previous medication for Major Depression
Item
4. Has the subject received any medication for past episodes of Major Depression which was stopped more than one month prior to the screening visit?
boolean
C0013227 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
Item Group
C0262926 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C1269683 (UMLS CUI-3)
Drug name
Item
Drug Name (trade name preferred)
text
C0013227 (UMLS CUI [1])
Item Group
HAM-D 17 IVRS prompt
C3639712 (UMLS CUI-1)
HAM-D 17
Item
Did the subject complete the HAM-D assessment at this visit via the Interactive Voice Response System (IVRS)?
boolean
C3639712 (UMLS CUI [1])
HAM-D 17 total score
Item
If 'Yes', was the subject's HAM-D total score >=18 at this visit?
boolean
C3639712 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Item Group
Physical Examination Prompt
C0031809 (UMLS CUI-1)
Physical Examination
Item
Was a physical examination completed for this visit?
boolean
C0031809 (UMLS CUI [1])
Physical Examination, abnormalities detected
Item
Were any abnormalities detected?
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Current Medical Conditions
C3899485 (UMLS CUI-1)
Body System
Item
Body System
text
C0460002 (UMLS CUI [1])
Condition
Item
Condition
text
C0012634 (UMLS CUI [1])
Item Group
Allergic History
C0020517 (UMLS CUI-1)
Item
Medical History (past or current)
text
C0262926 (UMLS CUI [1])
Medical History
Code List
Medical History (past or current)
CL Item
past (PAST)
CL Item
current (CURRENT)
Asthma
Item
Asthma
boolean
C0004096 (UMLS CUI [1])
Environmental Illness
Item
Environmental Allergy
boolean
C0282504 (UMLS CUI [1])
Food Allergy
Item
Food Allergy
boolean
C0016470 (UMLS CUI [1])
Food Allergy - Specify Food
Item
Specify Food
text
C0016452 (UMLS CUI [1])
Drug Hypersensitivity / Allergy
Item
Drug Hypersensitivity / Allergy
boolean
C0013182 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
Drug Hypersensitivity / Allergy - Specify Drug
Item
Specify Drug
text
C0013227 (UMLS CUI [1])
Bronchospasm
Item
Bronchospasm
boolean
C0006266 (UMLS CUI [1])
Rash
Item
Rash
boolean
C0015230 (UMLS CUI [1])
Urticaria
Item
Urticaria
boolean
C0042109 (UMLS CUI [1])
Pruritis
Item
Pruritis
boolean
C0033774 (UMLS CUI [1])
Angioedema
Item
Angioedema
text
C0002994 (UMLS CUI [1])
Serum Sickness
Item
Serum Sickness
boolean
C0036830 (UMLS CUI [1])
Stevens-Johnson Syndrome
Item
Stevens-Johnson Syndrome
boolean
C0038325 (UMLS CUI [1])
Anaphylaxis
Item
Anaphylaxis
boolean
C0002792 (UMLS CUI [1])
OTHER allergy
Item
OTHER
boolean
C0020517 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
OTHER allergy - specify
Item
Specify other:
text
C0020517 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Prior and Concomitant Medication Prompt
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
Prior and concomitant medication
Item
Has the subject taken any medication (including prescribed, non-prescribed and herbal) within one month of the screening visit, including those that are still ongoing?
boolean
C2826257 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Item Group
12-lead Electrocardiogram
C0430456 (UMLS CUI-1)
ECG completed
Item
Was the ECG trace completed at this visit?
boolean
C1623258 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
ECG Finding
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of urine samples
Item
Date of urine samples
date
C2371162 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory abnormalities
Item
After reviewing the laboratory results, are there any clinically significant abnormalities?
boolean
C1853129 (UMLS CUI [1])
Blood alcohol
Item
Did the subject have a blood alcohol level of >=15 mg/dl (0.015%) at Screening?
boolean
C0202304 (UMLS CUI [1])
Urine drug screen
Item
Result of urine drug screen?
boolean
C0202274 (UMLS CUI [1])
Item Group
C2348195 (UMLS CUI-1)
Serum hCG
Item
Was a serum HCG performed?
boolean
C2348195 (UMLS CUI [1])
Sample Date hCG
Item
Sample Date
date
C1302413 (UMLS CUI [1,1])
C2348195 (UMLS CUI [1,2])
Serum hCG Result
Item
Result
boolean
C2348195 (UMLS CUI [1])
Item Group
C1516637 (UMLS CUI-1)
C0947611 (UMLS CUI-3)
Inclusion Criteria
Item
Did the subject meet all of the inclusion criteria?
boolean
C1512693 (UMLS CUI [1])
Exclusion Criteria
Item
Did the subject meet any of the exclusion criteria?
boolean
C0680251 (UMLS CUI [1])
Comments
Item
Record any additional comments related to this visit
text
C0947611 (UMLS CUI [1])
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