ID

40148

Beschreibung

Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Stichworte

Versionen (1)
  1. 17.03.20 17.03.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. März 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455

Englisch

Screen - Vital Signs; Medical Conditions; Eligibility Question; Neurological Examination; ECG

1 Formulare  
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Blood pressure systolic
Beschreibung

Blood pressure systolic

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure diastolic
Beschreibung

Blood pressure diastolic

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Beschreibung

Position should be consistent throughout the study

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Beschreibung

Location should be consistent throughout the study

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Medical Conditions
Beschreibung

Medical Conditions

Alias
UMLS CUI-1
C0012634
MedDRA System Organ Class
Beschreibung

MedDRA System Organ Class

Datentyp

integer

Alias
UMLS CUI [1]
C2347091
Disease Status
Beschreibung

Disease Status

Datentyp

integer

Alias
UMLS CUI [1]
C0699749
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

Did the subject meet all the entry criteria?

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Neurological Examination
Beschreibung

Neurological Examination

Alias
UMLS CUI-1
C0027853
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
Beschreibung

If Yes record details on the Medical History or Serious Adverse Events forms as appropriate.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2349155
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0023524
ECG
Beschreibung

ECG

Alias
UMLS CUI-1
C1623258
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
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Ähnliche Modelle

Screen - Vital Signs; Medical Conditions; Eligibility Question; Neurological Examination; ECG

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Vital Signs
C0518766 (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
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Location of temperature
Code List
Location of temperature
CL Item
Oral (1)
CL Item
Rectal (2)
CL Item
Axilla (3)
CL Item
Tympanic (4)
CL Item
Intra-arterial (5)
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
CL Item
Blood and lymphatic system disorders (1)
CL Item
Cardiac disorders (2)
CL Item
Gastrointestinal disorders (3)
CL Item
Hepatobiliary disorders (4)
CL Item
Immune system disorders (5)
CL Item
Metabolism and nutrition disorders (6)
CL Item
Musculoskeletal and connective tissue disorders (7)
CL Item
Neoplasms benign, malignant and unspecified (including cysts and polyps) (8)
CL Item
Nervous system disorders (9)
CL Item
Respiratory, thoracic and mediastinal disorders (10)
CL Item
Skin and subcutaneous tissue disorders (11)
CL Item
Vascular disorders (12)
CL Item
Infections and infestations (13)
Item
Disease Status
integer
C0699749 (UMLS CUI [1])
Disease Status
Code List
Disease Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
Item
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
boolean
C0027853 (UMLS CUI [1,1])
C2349155 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2])
C0023524 (UMLS CUI [3])
Item Group
ECG
C1623258 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant (complete the Medical History/SAE form if clinically significant abnormalities meet the protocol definition for an AE/SAE) (3)
CL Item
No result (not available) (4)
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