Informações: Esta não é a versão mais recente do modelo de dados. Uma visão geral da versão pode ser encontrada à esquerda em Versões. Para a versão mais recente, clique aqui.
Informações:
Falhas:
ID
38144
Descrição
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder
Palavras-chave
Versões (2)
- 22/09/2019 22/09/2019 -
- 24/10/2019 24/10/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
22 de setembro de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363
Similar models
Screening
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Pharmacogenetic (PGx) Research Consent / Blood Sample Collection
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C0021430 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent
Item
Has informed consent been obtained for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Pharmacogenetic Test, Informed Consent, Date in time
Item
Yes, record Date informed consent obtained for PGx research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Item
Yes, record: Has Blood been collected for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Item
No (informed consent obtained), check reason
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
No (informed consent obtained), check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Pharmacogenetic Test, Informed Consent, Reason and justification
Item
Specify
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Pharmacogenetic (PGx) Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent, Withdraw
Item
Has subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Item
Yes, date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacogenetic Test, Blood specimen, Destruction, Request
Item
Has a request been made for blood sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Yes, check reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Code List
Yes, check reason
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Item
Specify
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Trial Screen Failure
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Item
Yes, check all that apply
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
CL Item
Did not meet inclusion/exclusion criteria (1)
CL Item
Adverse Event (unspecified) (2)
CL Item
Study closed/terminated (unspecified) (3)
CL Item
Lost to follow up (unspecified) (4)
CL Item
Investigator discretion, specify (5)
CL Item
Withdrew consent, specify (6)
Item
Specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
Trial Screen Failure, Clinical Study Case, Investigator Signature
Item
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re- sign the case book
boolean
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1706256 (UMLS CUI [1,3])
C2346576 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,2])
C1706256 (UMLS CUI [1,3])
C2346576 (UMLS CUI [1,4])
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Inclusion Criteria
text
C1512693 (UMLS CUI [1])
Code List
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Inclusion Criteria
CL Item
Male or female between the ages of 18 and 64 years inclusive. (1)
CL Item
Male subjects, if female partner not using an acceptable method of contraception, must agree to use one of the contraception methods listed in Section 8.1.2. This criterion must be followed from the time of the first dose of study medication until one month post-last dose. (3)
CL Item
BMI within the range 18.8 – 35.0 kg/m2 (inclusive). (4)
CL Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. (5)
CL Item
Subject currently meets the diagnosis for MDD (without psychotic features), single episode or recurrent, as defined in the DSM-IV-TR, diagnosed with SCID-CT (Structural Clinical Interview for DSM-IV Axis I disorders – Clinical Trials Version) as assessed* by a physician with adequate training in psychiatry. (6)
CL Item
Subject must, in the investigator’s opinion based on clinical history, have met DSM IV-TR criteria for their current major depressive episode for at least 4 weeks but for no greater than 24 months. (7)
CL Item
Subject has an independent rater HAMD17 total score ≥24, that is within 10% of the computerised HAMD17 total score, at the baseline assessment. If scores are not within 10% the independent rater or principal investigator, physician from CRS and GSK medical monitor must agree that subject is suitable for inclusion in the study. (8)
CL Item
Non-smoker or smokers (< 20 cigarettes per day). (9)
CL Item
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]; Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until one month post-last dose = 2. A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]; Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until one month post-last dose (2)
CL Item
Subject must read and write at a level sufficient to complete study-related assessments. (10)
Item
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Exclusion Criteria
text
C0680251 (UMLS CUI [1])
Code List
No, please select all boxes corresponding to violations of any inclusion/ exclusion criteria - Exclusion Criteria
CL Item
Subjects has: Symptoms of the presenting illness which are better accounted for by another diagnosis*; or A current DSM-IV-TR Axis I diagnosis of Dementia; or Antisocial or Borderline Personality Disorder or other current DSM-IV-TR Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non- compliance with the protocol; or A current (or within six months prior to the Screening visit) diagnosis of anorexia nervosa or bulimia; or A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder. (1)
CL Item
Subjects who, in the investigator’s judgement, pose a homicidal or serious suicidal risk, have made a suicide attempt within 6 months preceding screening or who have ever been homicidal. (2)
CL Item
Subject has initiated psychotherapy within one month prior to the Screening visit, or plans to initiate psychotherapy during the trial. Subjects who present with their current MDD diagnosis despite longer term psychotherapy (i.e., greater than three months prior to the Screening visit) and who agree to maintain the same therapy schedule during the trial may be included. (3)
CL Item
Subject has received vagus nerve stimulation, electroconvulsive therapy, or transcranial magnetic stimulation within the six months prior to the Screening visit. (4)
CL Item
Subject has previously failed an adequate therapeutic course of pharmacotherapy for MDD (e.g., for ≥ 4 weeks) from two different classes of antidepressants. (5)
CL Item
Subject has an unstable medical disorder or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GSK163090 or may pose a safety concern, or interfere with the accurate assessment of safety or efficacy. (6)
CL Item
The subject has a past history of drug abuse or dependence according to DSM-IV TR criteria within the past 12 months or has tested positive for urine drugs of abuse at pre-study screening except as detailed in Section 9.1.1. (7)
CL Item
Abuse of alcohol. To determine if a subject is abusing alcohol investigator will consider: average weekly intake of alcohol, score achieved on Alcohol Use Disorders Identification Test (AUDIT –C, Appendix 8 ) and results from laboratory assessments (in particular any abnormalities to AST: ALT ratio, GGT and MCV). (8)
CL Item
The subject has a past history of serotonin syndrome or in the investigator’s judgement, a history of clinical significant intolerance of SSRIs. (9)
CL Item
Subjects with a history of migraine headaches that respond to treatment with triptan medication. (10)
CL Item
The subject has a history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure). (11)
CL Item
A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. (12)
CL Item
The subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to the current illness, or six months for studies related to MDD. (13)
CL Item
The subject has a screening ECG with a QTc value of >450msec and or a PR interval outside the range 110 to 220msec or an ECG that is not suitable for QT measurements (e.g poorly defined termination of the T-wave). (14)
CL Item
Any cardiac condition or ECG evidence that the investigator feels may predispose the subject to ischemia or arrhythmia or any ECG abnormality that, in the investigator’s judgment, may pose a potential safety concern. (15)
CL Item
The subject has a systolic blood pressure (SBP) ≥160mmHg or a diastolic blood pressure (DBP) ≥ 100 mmHg verified by repeated measurement at the Screening or Randomization visit. (16)
CL Item
The subject has any liver function enzyme (ALT, AST, ALP or GGT) elevated > 2 times, or total or direct bilirubin>1.5 times (unless consistent with presumed or diagnosed Gilbert’s disease), above the reference range at pre-study screening that remains elevated with a repeat LFT. (17)
CL Item
Subjects who are not euthyroid based on lab results at the screening visit. Subjects maintained on thyroid medication must be euthyroid for a period of at least six months prior to the screen visit. (18)
CL Item
Subject has any laboratory abnormality that in the investigator’s judgement is considered to be clinically significant and could potentially affect subject safety or study outcome. (19)
CL Item
Subject is female and has a positive Human Chorionic Gonadotropin (HCG) pregnancy test at screen visit, a positive urine dipstick test at randomization, or who is lactating or planning to become pregnant within 4 weeks following the last dose of study medication. (20)
CL Item
Subject has received depot antipsychotics within the 12 weeks before screening. (21)
CL Item
Subject has taken a regular course of other psychoactive drugs within the two weeks (22)
CL Item
Subject has taken other (non-psychoactive) prescription, non-prescription, dietary, or herbal products that are potent or moderate inducers and/or inhibitors of the cytochrome P450 3A4 pathway for 2 weeks (or 5 half lives, whichever is longer) prior to the Randomization visit. (23)
CL Item
Subject has taken other (non-psychoactive) prescription, non-prescription, dietary, or herbal products metabolized via the cytochrome P450 3A4 pathway with a narrow therapeutic index within 2 weeks (or 5 half-lives, whichever is longer) prior to the Randomization visit. (24)
CL Item
Subject has taken other (non-psychoactive) prescription, non-prescription that are inhibitors of the P-glycoprotein for 2 weeks (or 5 half lives, whichever is longer) prior to the Randomization visit. (25)
CL Item
Use of monoamine oxidase inhibitors (MAOI) and linezolid (antibiotic) for 1 month prior to first dose of study medication. (26)
CL Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. (27)
CL Item
prior to the Screening Visit (except as discussed and permitted in section 9.1.1): All antidepressants including SSRIs (with the exception of fluoxetine, which requires 5 weeks), Long acting benzodiazepines, other psychoactive medications (including psychoactive herbal treatments, e.g., St. John’s Wort, SAM-E), Lithium, other mood stabilizers (including anticonvulsants) and oral antipsychotics, Opiates (including tramadol), hypnotics, and all other sedatives (including sedating antihistamines if they are used for their sedating and/or hypnotic properties) (prior to the Screening Visit (except as discussed and permitted in section 9.1.1): All antidepressants including SSRIs (with the exception of fluoxetine, which requires 5 weeks), Long acting benzodiazepines, other psychoactive medications (including psychoactive herbal treatments, e.g., St. John’s Wort, SAM-E), Lithium, other mood stabilizers (including anticonvulsants) and oral antipsychotics, Opiates (including tramadol), hypnotics, and all other sedatives (including sedating antihistamines if they are used for their sedating and/or hypnotic properties))
Concomitant Agent
Item
Were any medications recorded on the In-Clinic Medications Taken Diary?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Concomitant Agent, Medication name
Item
Drug Name (Trade Name preferred)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
Concomitant Agent, Medication name, Reported Term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
Concomitant Agent, Pharmaceutical Preparations, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Concomitant Agent, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Concomitant Agent, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Agent, Date in time
Item
Date Taken
date
C2347852 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Concomitant Agent, Time
Item
Time Taken
time
C2347852 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(1st Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(1st Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(2nd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(2nd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(3rd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(3rd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Diastolic blood pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
12 lead ECG, P-R Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
CL Item
No result (not available) (4)
12 lead ECG, QRS Axis
Item
QRS Axis
text
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
C0429012 (UMLS CUI [1,2])
12 lead ECG, RR interval
Item
RR interval
integer
C0430456 (UMLS CUI [1,1])
C0489636 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,2])
Clinical Study Case, Investigator Signature
Item
Is this casebook ready to sign?
boolean
C1706256 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
Clinical Study Case, Investigator Signature
Item
For Data Managers or Monitors only: Tick or untick this box to require the investigator to re- sign the case book
boolean
C1706256 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])