ID

42545

Descripción

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out whenever/if a serious adverse event occurred during study.

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Palabras clave

Versiones (1)
  1. 25/8/21 25/8/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de agosto de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Inglés

Serious Adverse event

1 formularios  
  1. StudyEvent: ODM
    1. Serious Adverse event
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
subject number
Descripción

subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
date of examination
Descripción

if different from date of visit

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C0011008
Type of Report
Descripción

Type of Report

Alias
UMLS CUI-1
C0585733
Initial Report
Descripción

[hidden]

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0205265
Follow-Up Report
Descripción

[hidden]

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1704685
Randomisation
Descripción

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Descripción

SAE occurance after initiation of study medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1704686
UMLS CUI [1,4]
C0304229
Serious Adverse Event Entry
Descripción

Serious Adverse Event Entry

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Descripción

[hidden] Use this itemgroup to enter details of the SAE. For additional SAEs that are clinically or temporally related (e.g., SAEs that occur during the same hospitalization) fill out the items of this itemgroup for entry of the addition.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event
Descripción

Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only.

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Modified term
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start Date
Descripción

Serious adverse event start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Start Time
Descripción

AE start time is required for all events starting on ofatumumab treatment days

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Outcome
Descripción

AE end time is required for all events starting on ofatumumab treatment days.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
If Recovered/Resolved, provide End Date
Descripción

Serious adverse event, recovered/resolved, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0806020
If Recovered/Resolved, provide End time
Descripción

AE end time is required for all events starting on ofatumumab treatment days

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C1522314
If Recovered/Resolved with sequelae, provide End Date
Descripción

Serious adverse event, recovered/resolved with sequelae, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0243088
UMLS CUI [1,4]
C0806020
If Recovered/Resolved with sequelae, provide End time
Descripción

AE end time is required for all events starting on ofatumumab treatment days

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0243088
UMLS CUI [1,4]
C1522314
If fatal, provide Date of Death
Descripción

Serious adverse event, fatal, Date of Death

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C1148348
If fatal, provide Time of Death
Descripción

AE end time is required for all events starting on ofatumumab treatment days

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C1301931
Maximum Intensity
Descripción

Record maximum intensity throughout duration of event. This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Intensity at onset of event
Descripción

Record intensity at the onset of the event [hidden] Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Grade/Grade or Intensity at onset of event item has been used.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0574845
Maximum Grade
Descripción

Record maximum grade throughout duration of event. This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Grade at onset of event
Descripción

Record grade at the onset of the event. [hidden] Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
Maximum Grade or Intensity
Descripción

Record maximum grade or intensity throughout duration of event. [hidden] This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0806909
UMLS CUI [2,3]
C0518690
Grade or Intensity at onset of event
Descripción

Record grade or intensity at the onset of the event [hidden] Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0441800
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C0518690
Action Taken with Investigational Product(s) as a Result of the AE
Descripción

Action Taken with Investigational Product(s) as a Result of the AE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this AE?
Descripción

Subject withdrawal from study as result of AE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0422727
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

Use best judgment at initial entry. May be amended when additional information becomes available. If the study has multiple IP then remove Yes and keep Yes, select appropriate investigational product(s)' and set selection value to Y. Otherwise remove Yes, select appropriate investigational product(s) and keep Yes.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332149
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1519255
Duration of AE if <24 hours
Descripción

[hidden]

Tipo de datos

integer

Unidades de medida
  • hours
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
hours
Duration of AE if <24 hours
Descripción

[hidden]

Tipo de datos

integer

Unidades de medida
  • minutes
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
minutes
Time to Onset Since Last Dose
Descripción

[hidden]

Tipo de datos

integer

Unidades de medida
  • hours
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1272706
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C3174092
UMLS CUI [1,6]
C1517741
hours
Time to Onset Since Last Dose
Descripción

[hidden]

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1272706
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C3174092
UMLS CUI [1,6]
C1517741
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Descripción

[hidden]

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0332300
UMLS CUI [1,5]
C0304229
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0085978
UMLS CUI [2,3]
C0199171
UMLS CUI [3,1]
C1519255
UMLS CUI [3,2]
C0085978
UMLS CUI [3,3]
C0005834
UMLS CUI [4,1]
C1519255
UMLS CUI [4,2]
C0085978
UMLS CUI [4,3]
C1710661
Was the event serious?
Descripción

[hidden]

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1710056
Related Investigational Product
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C1519255
Intensity Changes Entry
Descripción

Intensity Changes Entry

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0518690
UMLS CUI-3
C0392747
UMLS CUI-4
C0920316
Serious Adverse Event
Descripción

Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Start Date of event segment
Descripción

Serious adverse event, start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0808070
Start Time of event segment
Descripción

Hr:Min (00:00-23:59) If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C1301880
Intensity of event segment
Descripción

This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
Grade of event segment
Descripción

This item may be hidden if either the Intensity of event segment or Grade or intensity of event segment item has been used and item not included in the section. Grade 5 is optional.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
Grade or Intensity of event segment
Descripción

This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section. Grade 5 is optional.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C0518690
Seriousness
Descripción

Seriousness

Alias
UMLS CUI-1
C1710056
Results in death
Descripción

Specify the reason for considering this an SAE. Check all that apply.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1320832
Is life-threatening
Descripción

Specify the reason for considering this an SAE. Check all that apply.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalisation or prolongation of existing hospitalisation
Descripción

Specify the reason for considering this an SAE. Check all that apply.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Results in disability/incapacity
Descripción

Specify the reason for considering this an SAE. Check all that apply.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3176592
Congenital anomaly/birth defect
Descripción

Specify the reason for considering this an SAE. Check all that apply.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0000768
Other
Descripción

Specify the reason for considering this an SAE. Check all that apply.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1274040
If other, specify within general narrative comment
Descripción

Specify the reason for considering this an SAE. Check all that apply. [Enter protocol specific definition here]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C1521902
Relevant concomitant/Treatment medications Entry
Descripción

Relevant concomitant/Treatment medications Entry

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2347946
UMLS CUI-3
C0920316
CM Sequence Number
Descripción

Include details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE. [hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Drug name
Descripción

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Modified reported term
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C2826819
Dose
Descripción

Concomitant medication, dose

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3174092
Unit
Descripción

Include details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE.

Tipo de datos

text

Alias
UMLS CUI [1]
C2826646
Frequency
Descripción

Concomitant medication, Frequency

Tipo de datos

text

Alias
UMLS CUI [1]
C2826654
Route
Descripción

Concomitant medication, route

Tipo de datos

text

Alias
UMLS CUI [1]
C2826730
Start date
Descripción

Concomitant medication, start date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826734
Ongoing?
Descripción

Concomitant medication, ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
If no, specify End date
Descripción

Concomitant medication, ongoing, End date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0806020
Primary Indication
Descripción

Enter a medical diagnosis not description.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2826696
UMLS CUI [1,2]
C0205225
Modified reported term
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C2826819
Drug Type
Descripción

Concomitante medication, Drug Type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0457591
Relevant medical conditions/Risk factors entry
Descripción

Relevant medical conditions/Risk factors entry

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347946
UMLS CUI-3
C0262926
UMLS CUI-4
C0035648
MHx Sequence Number
Descripción

Use this itemgroup to enter each past or current medical disorder, allergy or surgery that may be RELEVANT to the SAE. Enter a diagnosis, not description. Relevant family or social history should be described in the ‘General Narrative Comments’ at the bottom of this form. [hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
Specific Condition Name
Descripción

Enter a medical diagnosis not description.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2348235
Modified reported term
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C2826728
Date of onset
Descripción

Medical history, date of onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0262926
Continuing?
Descripción

Medical history, continuing

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0549178
If no, specify date of last occurrence
Descripción

Medical history, date of last occurrence

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0011008
Relevant Medical History / Risk Factors not noted above
Descripción

Relevant Medical History / Risk Factors not noted above

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0035648
UMLS CUI [2,4]
C0205394
Relevant Diagnostic Results Entry
Descripción

Relevant Diagnostic Results Entry

Alias
UMLS CUI-1
C2347946
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
UMLS CUI-4
C1519255
Lab Sequence Number
Descripción

Provide details of any tests or procedures carried out to diagnose the SAE. [hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Test Name
Descripción

Provide details of any tests or procedures carried out to diagnose the SAE. Only allow site to choose from List of Values.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C2826273
Test Date
Descripción

Provide details of any tests or procedures carried out to diagnose the SAE.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C2826247
Test Result
Descripción

Provide details of any tests or procedures carried out to diagnose the SAE.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
Test Units
Descripción

Provide details of any tests or procedures carried out to diagnose the SAE.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0430022
Normal Low Range
Descripción

Provide details of any tests or procedures carried out to diagnose the SAE.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1518030
Normal High Range
Descripción

Provide details of any tests or procedures carried out to diagnose the SAE.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1519815
Relevant diagnostic results not noted above
Descripción

Provide details of any tests or procedures carried out to diagnose the SAE.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C0205394
Rechallenge
Descripción

Rechallenge

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347900
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Descripción

Serious adverse event recurrence after investigational products restarted

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C2347900
Investigational Product Entry
Descripción

Investigational Product Entry

Alias
UMLS CUI-1
C0304229
Study Drug
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Start Date
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Investigational Product Entry
Descripción

Investigational Product Entry

Alias
UMLS CUI-1
C0304229
Study Drug
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
Start Date
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Investigational Product Entry
Descripción

Investigational Product Entry

Alias
UMLS CUI-1
C0304229
Study Drug
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Start Date
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Stop Date
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Dose
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
Cumulative Dose
Descripción

Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies). This item is conditional

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2986497
General Narrative Comments
Descripción

General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
General Narrative Comments
Descripción

Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Non Clinical
Descripción

Non Clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0205210
UMLS CUI-3
C1298908
Send incomplete data to GSK Safety
Descripción

[hidden]

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0036043
UMLS CUI [1,3]
C1511726
UMLS CUI [1,4]
C0205257
Receipt by GSK date
Descripción

[hidden]

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985846
Was the event serious?
Descripción

[hidden]

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1710056
SAE Sequence Number
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0333052
UMLS CUI [1,3]
C0237753
Case ID
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1698493
UMLS CUI [1,3]
C0600091
Randomisation Number
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0237753
OCEANS Code
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
Email Flag
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013849
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Similar models

Serious Adverse event

1 formularios
  1. StudyEvent: ODM
    1. Serious Adverse event
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
date of examination
Item
date of examination
date
C0582103 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Type of Report
C0585733 (UMLS CUI-1)
Initial Report
Item
Initial Report
boolean
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Follow-Up Report
Item
Follow-Up Report
boolean
C1704685 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
SAE occurance after initiation of study medication
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Item Group
Serious Adverse Event Entry
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Serious adverse event start date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious adverse event start time
Item
Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
Serious adverse event, recovered/resolved, End Date
Item
If Recovered/Resolved, provide End Date
date
C1519255 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious adverse event, recovered/resolved, End time
Item
If Recovered/Resolved, provide End time
time
C1519255 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Serious adverse event, recovered/resolved with sequelae, End Date
Item
If Recovered/Resolved with sequelae, provide End Date
date
C1519255 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Serious adverse event, recovered/resolved with sequelae, End time
Item
If Recovered/Resolved with sequelae, provide End time
time
C1519255 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Serious adverse event, fatal, Date of Death
Item
If fatal, provide Date of Death
date
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,3])
Serious adverse event, fatal, Time of Death
Item
If fatal, provide Time of Death
time
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1301931 (UMLS CUI [1,3])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious adverse event, Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Serious adverse event, Maximum Intensity
Code List
Intensity at onset of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious adverse event, maximum grade
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade at onset of event
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Serious adverse event, maximum grade
Code List
Grade at onset of event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,3])
Serious adverse event, Maximum Grade or Intensity
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Grade or Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,3])
Serious adverse event, Maximum Grade or Intensity
Code List
Grade or Intensity at onset of event
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose reduced (2)
CL Item
Dose increase (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Subject withdrawal from study as result of AE
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Possibility that AE was caused by investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0332149 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Duration of AE
Item
Duration of AE if <24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of AE
Item
Duration of AE if <24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Serious adverse event, Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C1519255 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C3174092 (UMLS CUI [1,5])
C1517741 (UMLS CUI [1,6])
Serious adverse event, Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C1519255 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C3174092 (UMLS CUI [1,5])
C1517741 (UMLS CUI [1,6])
SAE cause related to study participation except for investigational product (e.g. procedures, blood draws, washout)
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0332300 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C1519255 (UMLS CUI [2,1])
C0085978 (UMLS CUI [2,2])
C0199171 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0085978 (UMLS CUI [3,2])
C0005834 (UMLS CUI [3,3])
C1519255 (UMLS CUI [4,1])
C0085978 (UMLS CUI [4,2])
C1710661 (UMLS CUI [4,3])
Adverse event seriousness
Item
Was the event serious?
boolean
C1710056 (UMLS CUI [1])
Investigational Product related to serious adverse event
Item
Related Investigational Product
text
C0304229 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Intensity Changes Entry
C1519255 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)
C0920316 (UMLS CUI-4)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious adverse event, start date
Item
Start Date of event segment
date
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious adverse event, start time
Item
Start Time of event segment
time
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Intensity of event segment
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Serious adverse event, maximum grade
Code List
Grade of event segment
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade or Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,3])
Serious adverse event, Maximum Grade or Intensity
Code List
Grade or Intensity of event segment
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item Group
Seriousness
C1710056 (UMLS CUI-1)
Adverse event resulting in death
Item
Results in death
boolean
C1320832 (UMLS CUI [1])
Adverse event, life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
Adverse event, requiring hospitalisation or prolonged hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Seriousness of adverse event, results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3176592 (UMLS CUI [2,2])
Seriousness of adverse event, congenital anomaly
Item
Congenital anomaly/birth defect
boolean
C1710056 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Seriousness of adverse event, other result
Item
Other
boolean
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Seriousness of adverse event, other result, specification
Item
If other, specify within general narrative comment
text
C1710056 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
Relevant concomitant/Treatment medications Entry
C2347852 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0920316 (UMLS CUI-3)
CM Sequence Number
Item
CM Sequence Number
text
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant medication, dose
Item
Dose
text
C2347852 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item
Unit
text
C2826646 (UMLS CUI [1])
Concomitant medication, Unit
Code List
Unit
CL Item
Actuation  (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (AP)
CL Item
Bottle (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter  (CC)
CL Item
Drops (031)
CL Item
Gram  (002)
CL Item
International units  (025)
CL Item
International units per kilogram  (028)
CL Item
International units per millilitre  (IUML)
CL Item
Litre  (011)
CL Item
Litre per minute  (LM)
CL Item
Lozenge  (LOZ)
CL Item
Megaunits (million units)  (MEGU)
CL Item
Microgram (MCG)  (004)
CL Item
Microgram (UG) (004.1)
CL Item
Microgram/kilogram  (008)
CL Item
Microgram/kilogram per minute  (MCG/KG/MIN)
CL Item
Micrograms per minute  (MCG/MIN)
CL Item
Microlitre  (013)
CL Item
Milliequivalent  (029)
CL Item
Milliequivalent per 24 hours  (MEQ24)
CL Item
Milligram  (003)
CL Item
Milligrams percent  (MGPER)
CL Item
Milligram per hour  (MGH)
CL Item
Milligram/kilogram  (007)
CL Item
Milligram/kilogram per hour  (MGKH)
CL Item
Milligram/kilogram per minute  (MGKM)
CL Item
Milligram/metre squared  (009)
CL Item
Milligram/millilitre  (MGML)
CL Item
Millilitre  (012)
CL Item
Millilitre per hour  (MLH)
CL Item
Millilitre per minute  (MLM)
CL Item
Millimole  (023)
CL Item
Million international units  (027)
CL Item
Minimum alveolar concentration  (MAC)
CL Item
Nebule (NEB)
CL Item
Patch (PAT)
CL Item
Percent (030)
CL Item
Puff (PUFF)
CL Item
Sachet  (SAC)
CL Item
Spray  (SPR)
CL Item
Suppository  (SUP)
CL Item
Tablespoon (TBS)
CL Item
Tablet  (TAB)
CL Item
Teaspoon  (TSP)
CL Item
Units (UNT)
CL Item
Unknown (U)
CL Item
Vial  (VIA)
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant medication, Frequency
Code List
Frequency
CL Item
2 times per week (2W)
CL Item
3 times per week  (3W)
CL Item
4 times per week  (4W)
CL Item
5 times per day  (5D)
CL Item
5 times per week  (5W)
CL Item
AC (AC)
CL Item
Q12H  (2D)
CL Item
Continuous infusion  (CO)
CL Item
Every 2 weeks  (FO)
CL Item
Every 3 weeks  (Q3W)
CL Item
Every 3 months  (Q3M)
CL Item
Every other day  (AD)
CL Item
At Bedtime  (1N)
CL Item
Once a month  (MO)
CL Item
Once a week  (WE)
CL Item
Once daily  (1D)
CL Item
Once only  (1S)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q2H  (12D)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
Q4H  (6D)
CL Item
Q6H  (4D)
CL Item
Q8H  (3D)
CL Item
Q12H  (2D)
CL Item
QAM  (1M)
CL Item
QH  (24D)
CL Item
QID  (4D.2)
CL Item
QPM  (1N.2)
CL Item
TID  (3D.2)
CL Item
Unknown  (U)
Item
Route
text
C2826730 (UMLS CUI [1])
Concomitant medication, route
Code List
Route
CL Item
Both eyes  (047)
CL Item
Epidural  (008)
CL Item
Gastrostomy tube  (GT)
CL Item
Inhalation  (055)
CL Item
Injection  (INJ)
CL Item
Intra-arterial  (013)
CL Item
Intra-bursa  (IBU)
CL Item
Intralesional  (026)
CL Item
Intramuscular  (030)
CL Item
Intranasal  (045.1)
CL Item
Intraocular  (031)
CL Item
Intraosteal  (IOS)
CL Item
Intraperitoneal  (033)
CL Item
Intrathecal  (037)
CL Item
Intrauterine  (015)
CL Item
Intravenous  (042)
CL Item
Nasal  (045)
CL Item
Oral  (048)
CL Item
Rectal  (054)
CL Item
Subcutaneous  (058)
CL Item
Sublingual  (060)
CL Item
Topical  (061)
CL Item
Transdermal  (062)
CL Item
Unknown  (065)
CL Item
Vaginal  (067)
Concomitant medication, start date
Item
Start date
date
C2826734 (UMLS CUI [1])
Concomitant medication, ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant medication, ongoing, End date
Item
If no, specify End date
date
C2826666 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Concomitant medication, Primary Indication
Item
Primary Indication
text
C2826696 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Item
Drug Type
text
C2347852 (UMLS CUI [1,1])
C0457591 (UMLS CUI [1,2])
Concomitante medication, Drug Type
Code List
Drug Type
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
Item Group
Relevant medical conditions/Risk factors entry
C1519255 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0035648 (UMLS CUI-4)
MHx Sequence Number
Item
MHx Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Medical history, Specific Condition Name
Item
Specific Condition Name
text
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Modified reported term
Item
Modified reported term
text
C2826728 (UMLS CUI [1])
Medical history, date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Item
Continuing?
text
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Medical history, continuing
Code List
Continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Medical history, date of last occurrence
Item
If no, specify date of last occurrence
date
C0262926 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Relevant Medical History / Risk Factors not noted above
Item
Relevant Medical History / Risk Factors not noted above
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
Item Group
Relevant Diagnostic Results Entry
C2347946 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C1519255 (UMLS CUI-4)
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
text
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time (Activated partial thromboplastin time)
CL Item
Albumin (Albumin)
CL Item
Alkaline phosphatase (Alkaline phosphatase)
CL Item
Amylase (Amylase)
CL Item
Basophils (Basophils)
CL Item
Bicarbonate (Bicarbonate)
CL Item
Bilirubin (Bilirubin)
CL Item
Bilirubin direct (Bilirubin direct)
CL Item
Bilirubin total (Bilirubin total)
CL Item
Blood myoglobin (Blood myoglobin)
CL Item
Blood pH (Blood pH)
CL Item
Blood pressure (Blood pressure)
CL Item
Blood urea nitrogen (Blood urea nitrogen)
CL Item
Body temperature (Body temperature)
CL Item
Calcium (Calcium)
CL Item
CD4 lymphocytes (CD4 lymphocytes)
CL Item
CD8 lymphocytes (CD8 lymphocytes)
CL Item
Chloride (Chloride)
CL Item
Cholesterol total (Cholesterol total)
CL Item
C-reactive protein (C-reactive protein)
CL Item
Creatine (Creatine)
CL Item
Creatine phosphokinase (Creatine phosphokinase)
CL Item
Creatine phosphokinase MB (Creatine phosphokinase MB)
CL Item
Creatinine (Creatinine)
CL Item
Creatinine clearance (Creatinine clearance)
CL Item
Diastolic blood pressure (Diastolic blood pressure)
CL Item
Eosinophils (Eosinophils)
CL Item
Erythrocyte sedimentation rate (Erythrocyte sedimentation rate)
CL Item
Fasting blood glucose (Fasting blood glucose)
CL Item
FEV 1 (FEV 1)
CL Item
Gamma-glutamyltransferase (Gamma-glutamyltransferase)
CL Item
Glutamic-oxaloacetic transferase (Glutamic-oxaloacetic transferase)
CL Item
Glutamic-pyruvate transaminase (Glutamic-pyruvate transaminase)
CL Item
HbA1c (HbA1c)
CL Item
HBV-DNA decreased (HBV-DNA decreased)
CL Item
HBV-DNA increased (HBV-DNA increased)
CL Item
Heart rate (Heart rate)
CL Item
Hematocrit (Hematocrit)
CL Item
Hemoglobin (Hemoglobin)
CL Item
High density lipoprotein (High density lipoprotein)
CL Item
HIV viral load (HIV viral load)
CL Item
INR (INR)
CL Item
Lactic dehydrogenase (Lactic dehydrogenase)
CL Item
Lipase (Lipase)
CL Item
Low density lipoprotein (Low density lipoprotein)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Magnesium (Magnesium)
CL Item
Mean cell hemoglobin concentration (Mean cell hemoglobin concentration)
CL Item
Mean corpuscular hemoglobin (Mean corpuscular hemoglobin)
CL Item
Mean corpuscular volume (Mean corpuscular volume)
CL Item
Monocytes (Monocytes)
CL Item
Neutrophils (Neutrophils)
CL Item
Oxygen saturation (Oxygen saturation)
CL Item
pCO2 (pCO2)
CL Item
pH (pH)
CL Item
Phosphate (Phosphate)
CL Item
Platelet count (Platelet count)
CL Item
pO2 (pO2)
CL Item
Potassium (Potassium)
CL Item
Protein total (Protein total)
CL Item
Prothrombin time (Prothrombin time)
CL Item
Red blood cell count (Red blood cell count)
CL Item
Respiratory rate (Respiratory rate)
CL Item
Reticulocyte count (Reticulocyte count)
CL Item
Serum glucose (Serum glucose)
CL Item
Serum uric acid (Serum uric acid)
CL Item
Sodium (Sodium)
CL Item
Systolic blood pressure (Systolic blood pressure)
CL Item
Thrombin time (Thrombin time)
CL Item
Total lung capacity (Total lung capacity)
CL Item
Triglycerides (Triglycerides)
CL Item
Troponin (Troponin)
CL Item
Troponin I (Troponin I)
CL Item
Troponin T (Troponin T)
CL Item
Urine myoglobin (Urine myoglobin)
CL Item
Urine pH (Urine pH)
CL Item
Vital capacity (Vital capacity)
CL Item
White blood cell count (White blood cell count)
Test Date
Item
Test Date
date
C0430022 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Test Result
Item
Test Result
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Diagnostic procedure, Normal Low Range
Item
Normal Low Range
text
C0430022 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])
Diagnostic procedure, Normal High Range
Item
Normal High Range
text
C0430022 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Rechallenge
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2347900 (UMLS CUI [1,5])
Serious adverse event recurrence after investigational products restarted
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Investigational Product Entry
C0304229 (UMLS CUI-1)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Actual study drug or blinded trial medication 1. (Actual study drug or blinded trial medication 1.)
CL Item
Actual study drug or blinded trial medication 2. (Actual study drug or blinded trial medication 2.)
CL Item
Actual study drug or blinded trial medication 3. (Actual study drug or blinded trial medication 3.)
Investigational Product, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product, Stop Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Investigational Product Entry
C0304229 (UMLS CUI-1)
Item
Study Drug
text
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Study Drug
Code List
Study Drug
CL Item
Dose level 1 (Dose level 1)
CL Item
Dose level 2 (Dose level 2)
CL Item
Dose level 3 (Dose level 3)
Investigational Product, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product, Stop Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Investigational Product Entry
C0304229 (UMLS CUI-1)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Ofatumumab (66)
CL Item
Chlorambucil (68)
Investigational Product, Start Date
Item
Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigational Product, Stop Date
Item
Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Investigational Product, Dose
Item
Dose
text
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
Investigational Product, Cumulative Dose
Item
Cumulative Dose
text
C0304229 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Item Group
General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious adverse event, General Narrative Comments
Item
General Narrative Comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Non Clinical
C1519255 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
Incomplete data to GSK Safety
Item
Send incomplete data to GSK Safety
boolean
C1519255 (UMLS CUI [1,1])
C0036043 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C0205257 (UMLS CUI [1,4])
Serious adverse event, Receipt by GSK date
Item
Receipt by GSK date
datetime
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
Adverse event serious?
Item
Was the event serious?
boolean
C1710056 (UMLS CUI [1])
Serious Adverse Event Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event, Version Number
Item
Version Number
text
C1519255 (UMLS CUI [1,1])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Case ID
Item
Case ID
text
C1519255 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Serious Adverse Event, Randomisation Number
Item
Randomisation Number
text
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, OCEANS Code
Item
OCEANS Code
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Serious Adverse Event, Email Flag
Item
Email Flag
text
C1519255 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
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