ID
42545
Beschrijving
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
Trefwoorden
Versies (1)
- 25-08-21 25-08-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 augustus 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Serious Adverse event
- StudyEvent: ODM
Beschrijving
Type of Report
Alias
- UMLS CUI-1
- C0585733
Beschrijving
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beschrijving
Serious Adverse Event Entry
Alias
- UMLS CUI-1
- C1519255
Beschrijving
[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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only.
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826798
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C1140263
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Serious adverse event start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beschrijving
AE start time is required for all events starting on ofatumumab treatment days
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beschrijving
AE end time is required for all events starting on ofatumumab treatment days.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious adverse event, recovered/resolved, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0806020
Beschrijving
AE end time is required for all events starting on ofatumumab treatment days
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C1522314
Beschrijving
Serious adverse event, recovered/resolved with sequelae, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0243088
- UMLS CUI [1,4]
- C0806020
Beschrijving
AE end time is required for all events starting on ofatumumab treatment days
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0243088
- UMLS CUI [1,4]
- C1522314
Beschrijving
Serious adverse event, fatal, Date of Death
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C1148348
Beschrijving
AE end time is required for all events starting on ofatumumab treatment days
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C1301931
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0574845
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0332162
Beschrijving
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.
Datatype
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
Beschrijving
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
Datatype
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
Beschrijving
Action Taken with Investigational Product(s) as a Result of the AE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Subject withdrawal from study as result of AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0422727
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332149
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C1519255
Beschrijving
[hidden]
Datatype
integer
Maateenheden
- hours
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschrijving
[hidden]
Datatype
integer
Maateenheden
- minutes
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschrijving
[hidden]
Datatype
integer
Maateenheden
- 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
Beschrijving
[hidden]
Datatype
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
Beschrijving
[hidden]
Datatype
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
Beschrijving
[hidden]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C1519255
Beschrijving
Intensity Changes Entry
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0518690
- UMLS CUI-3
- C0392747
- UMLS CUI-4
- C0920316
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious adverse event, start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0808070
Beschrijving
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.
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C1301880
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0518690
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0441800
Beschrijving
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.
Datatype
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
Beschrijving
Seriousness
Alias
- UMLS CUI-1
- C1710056
Beschrijving
Specify the reason for considering this an SAE. Check all that apply.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1320832
Beschrijving
Specify the reason for considering this an SAE. Check all that apply.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschrijving
Specify the reason for considering this an SAE. Check all that apply.
Datatype
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
Beschrijving
Specify the reason for considering this an SAE. Check all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C3176592
Beschrijving
Specify the reason for considering this an SAE. Check all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0000768
Beschrijving
Specify the reason for considering this an SAE. Check all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1274040
Beschrijving
Specify the reason for considering this an SAE. Check all that apply. [Enter protocol specific definition here]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1274040
- UMLS CUI [1,4]
- C1521902
Beschrijving
Relevant concomitant/Treatment medications Entry
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0920316
Beschrijving
Include details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE. [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Beschrijving
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
Concomitant medication, dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3174092
Beschrijving
Include details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
Datatype
text
Alias
- UMLS CUI [1]
- C2826646
Beschrijving
Concomitant medication, Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C2826654
Beschrijving
Concomitant medication, route
Datatype
text
Alias
- UMLS CUI [1]
- C2826730
Beschrijving
Concomitant medication, start date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant medication, ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Concomitant medication, ongoing, End date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0806020
Beschrijving
Enter a medical diagnosis not description.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826696
- UMLS CUI [1,2]
- C0205225
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
Concomitante medication, Drug Type
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0457591
Beschrijving
Relevant medical conditions/Risk factors entry
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0262926
- UMLS CUI-4
- C0035648
Beschrijving
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]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beschrijving
Enter a medical diagnosis not description.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C2348235
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826728
Beschrijving
Medical history, date of onset
Datatype
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0262926
Beschrijving
Medical history, continuing
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0549178
Beschrijving
Medical history, date of last occurrence
Datatype
date
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C0011008
Beschrijving
Relevant Medical History / Risk Factors not noted above
Datatype
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
Beschrijving
Relevant Diagnostic Results Entry
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
- UMLS CUI-4
- C1519255
Beschrijving
Provide details of any tests or procedures carried out to diagnose the SAE. [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beschrijving
Provide details of any tests or procedures carried out to diagnose the SAE. Only allow site to choose from List of Values.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C2826273
Beschrijving
Provide details of any tests or procedures carried out to diagnose the SAE.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C2826247
Beschrijving
Provide details of any tests or procedures carried out to diagnose the SAE.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
Beschrijving
Provide details of any tests or procedures carried out to diagnose the SAE.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0430022
Beschrijving
Provide details of any tests or procedures carried out to diagnose the SAE.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1518030
Beschrijving
Provide details of any tests or procedures carried out to diagnose the SAE.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1519815
Beschrijving
Provide details of any tests or procedures carried out to diagnose the SAE.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2347946
- UMLS CUI [1,4]
- C0205394
Beschrijving
Rechallenge
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347900
Beschrijving
Serious adverse event recurrence after investigational products restarted
Datatype
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
Beschrijving
Investigational Product Entry
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Investigational Product Entry
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Investigational Product Entry
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Monotherapy use one row only. Multiple study drug regimens, use multiple rows as appropriate. (this will apply to any multi phase studies).
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0678766
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2986497
Beschrijving
General Narrative Comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0947611
Beschrijving
Non Clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C1298908
Beschrijving
[hidden]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0036043
- UMLS CUI [1,3]
- C1511726
- UMLS CUI [1,4]
- C0205257
Beschrijving
[hidden]
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2985846
Beschrijving
[hidden]
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0333052
- UMLS CUI [1,3]
- C0237753
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1698493
- UMLS CUI [1,3]
- C0600091
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0237753
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0805701
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013849
Similar models
Serious Adverse event
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2348184 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1709863 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1709863 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C1301931 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
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])
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])
C1519255 (UMLS CUI [1,2])
C0422727 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
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])
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])
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])
C0439849 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)
C0920316 (UMLS CUI-4)
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
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])
C1514873 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3176592 (UMLS CUI [2,2])
C0000768 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C2347946 (UMLS CUI-2)
C0920316 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,2])
C2347946 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0035648 (UMLS CUI-4)
C0262926 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C2745955 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
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])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C1519255 (UMLS CUI-4)
C2348184 (UMLS CUI [1,2])
C2826247 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
C1518030 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2347900 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2347900 (UMLS CUI [1,5])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
C0036043 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C0205257 (UMLS CUI [1,4])
C2985846 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,2])