ID

40230

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. 23.03.20 23.03.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. März 2020

DOI

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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

Visit 9 - Vital Signs; ECG; Neurological Examination

1 Formulare  
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
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
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
Was there a clinically significant change from baseline?
Beschreibung

Was there a clinically significant change from baseline?

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C2826293
UMLS CUI [1,4]
C1442488
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
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Ähnliche Modelle

Visit 9 - Vital Signs; ECG; Neurological Examination

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
integer
C0005910 (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
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 AE/SAE form if clinically significant abnormalities meet the protocol definition for an AE/SAE) (3)
CL Item
No result (not available) (4)
Item
Was there a clinically significant change from baseline?
text
C1623258 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,4])
Was there a clinically significant change from baseline?
Code List
Was there a clinically significant change from baseline?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (X)
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])
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