ID
41824
Beschrijving
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the serious adverse event documentation. If you wish to record a new SAE please determine if the new SAE is clinically or temporally related to an SAE previously entered on this form. If yes, record it in the same instance of the form. If not clinically or temporally related, create a new instance of the SAE form. Do not record pre and post randomization events on the same form.
Link
https://clinicaltrials.gov/ct2/show/NCT00821054
Trefwoorden
Versies (1)
- 23-01-21 23-01-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 januari 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054
Serious Adverse Events (SAE)
- 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
Item is not required, hidden
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 on,y
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Condition Item. Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Datatype
partialDatetime
Maateenheden
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beschrijving
SAE Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
End time is optional.
Datatype
partialDatetime
Maateenheden
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1709863
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1522314
- UMLS CUI [2,3]
- C1709863
Beschrijving
End time is optional.
Datatype
partialDatetime
Maateenheden
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1709863
- UMLS CUI [1,4]
- C0243088
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1522314
- UMLS CUI [2,3]
- C1709863
- UMLS CUI [2,4]
- C0243088
Beschrijving
SAE Date and Time of Death
Datatype
partialDatetime
Maateenheden
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3899439
Beschrijving
Record maximum intensity throughout duration of event. Optional Item. This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used. Item is not required, hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Conditional Item. 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.Record intensity at the onset of the event. Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0332162
Beschrijving
Optional Item. This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.Record maximum grade throughout duration of event
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
Beschrijving
Conditional Item. 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 Record grade at the onset of the event
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
- UMLS CUI [1,4]
- C0332162
Beschrijving
Optional Item. This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional. Record maximum grade or intensity throughout duration of event. Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0441800
- UMLS CUI [2,3]
- C0806909
Beschrijving
Conditional Item: 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 Record grade of intensity at the onset of the event. Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0332162
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C0441800
- UMLS CUI [2,2]
- C0332162
- UMLS CUI [2,3]
- C1519255
Beschrijving
SAE Action taken with study treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Beschrijving
Patient withdrawn from trial because of SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beschrijving
Use best judgement 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
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
HH:MM Item is not required, hidden. If AE start and end time are used this item must be hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschrijving
HH:MM Item is not required, hidden. This item is optional.
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
- UMLS CUI [1,3]
- C0946444
Beschrijving
SAE caused by study participation, procedures, blood draws, washout; investigational product absent
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0085978
- UMLS CUI [2,3]
- C2700391
- 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
- UMLS CUI [5,1]
- C0332197
- UMLS CUI [5,2]
- C0304229
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beschrijving
Intensity Changes
Alias
- UMLS CUI-1
- C1710066
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0518690
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
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. Item is not required, hidden
Datatype
partialDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0449719
- UMLS CUI [2,3]
- C1301880
Beschrijving
Item is not required, hidden
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0518690
Beschrijving
Optional Item: 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
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2985911
- UMLS CUI [1,3]
- C0449719
Beschrijving
Optional Item: 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. Item is not required, hidden
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0449719
- UMLS CUI [2]
- C2985911
Beschrijving
Seriousness
Alias
- UMLS CUI-1
- C1710056
- UMLS CUI-2
- C1519255
Beschrijving
SAE seriousness: Results in death
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1705232
- UMLS CUI [2,2]
- C1519255
Beschrijving
SAE seriousness: Is life-threatening
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1517874
- UMLS CUI [2,2]
- C1519255
Beschrijving
SAE seriousness: Requires hospitalisation or prolongation of existing hospitalisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0019993
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C0745041
Beschrijving
SAE seriousness: Results in disability/incapacity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0231170
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C3176592
Beschrijving
SAE seriousness: Congenital anomaly
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0000768
- UMLS CUI [2,2]
- C1519255
Beschrijving
SAE seriousness: Other, specify
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1710056
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1521902
Beschrijving
SAE seriousness: Cardiovascular or hepatobiliary events
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1320716
- UMLS CUI [2,2]
- C1519255
- UMLS CUI [3,1]
- C0267792
- UMLS CUI [3,2]
- C1519255
Beschrijving
Relevant concomitant/treatment medications Entry
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1519255
Beschrijving
Item is not required, hidden
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C2348184
Beschrijving
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826302
- UMLS CUI [1,4]
- C0013227
Beschrijving
Item is not required
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0869039
- UMLS CUI [1,4]
- C0013227
Beschrijving
Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0869039
Beschrijving
Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C3476109
- UMLS CUI [1,4]
- C0013227
Beschrijving
Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0013227
Beschrijving
day month year. Item is not required
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0808070
- UMLS CUI [1,4]
- C0013227
Beschrijving
Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0549178
- UMLS CUI [1,4]
- C0013227
Beschrijving
Item is not required
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0806020
Beschrijving
Enter a medical diagnosis not description. Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C0013227
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826923
Beschrijving
SAE relevant Drug type
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0457591
- UMLS CUI [1,4]
- C0013227
Beschrijving
Relevant Medical Conditions/Risk Factors Entry
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C2347946
- UMLS CUI-4
- C1519255
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2348184
- UMLS CUI [1,4]
- C0262926
Beschrijving
Enter a medical diagnosis not description.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C2348235
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826923
Beschrijving
Item is not required
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C2347946
- UMLS CUI [1,4]
- C1519255
- UMLS CUI [2,1]
- C0574845
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [2,3]
- C2347946
- UMLS CUI [2,4]
- C1519255
Beschrijving
Item not required.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C0549178
Beschrijving
Item not required.
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0012634
- UMLS CUI [1,5]
- C2347946
- UMLS CUI [1,6]
- C1519255
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [1,4]
- C1519255
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2347946
- UMLS CUI [2,3]
- C0035648
- UMLS CUI [2,4]
- C1519255
Beschrijving
Relevant diagnostic results Entry
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0430022
- UMLS CUI-4
- C0456984
Beschrijving
Item is not required, hidden
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0022885
- UMLS CUI [1,4]
- C2348184
Beschrijving
Only allow site to choose from List of Values.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0022885
Beschrijving
SAE relevant Laboratory Test Date
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826641
Beschrijving
SAE relevant Laboratory Test Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0587081
Beschrijving
Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519795
- UMLS CUI [1,4]
- C0587081
Beschrijving
Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826705
- UMLS CUI [1,4]
- C1518030
Beschrijving
Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826705
- UMLS CUI [1,4]
- C1519815
Beschrijving
Item is not required
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C2347946
- UMLS CUI [1,4]
- C1519255
- UMLS CUI [1,5]
- C0205394
Beschrijving
Rechallenge
Alias
- UMLS CUI-1
- C2347900
Beschrijving
Recurrence of SAE after experimental drug rechallenge post discontinuation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C2347900
- UMLS CUI [1,5]
- C0687676
- UMLS CUI [1,6]
- C0457454
Beschrijving
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Item is not required.
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Time is optional. Item is not required.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Time is optional. Item is not required.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Optional Item: This item may be hidden. Item is not required.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0304229
Beschrijving
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Beschrijving
Non Clinical
Alias
- UMLS CUI-2
- C1298908
- UMLS CUI-1
- C0205210
Beschrijving
This item is optional. Item is not required, hidden.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beschrijving
Item is not required, hidden
Datatype
partialDatetime
Maateenheden
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1511726
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1511726
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C3887242
Beschrijving
Item is not required, hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0013849
Similar models
Serious Adverse Events (SAE)
- StudyEvent: ODM
C0304229 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1709863 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C1709863 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C1709863 (UMLS CUI [1,3])
C0243088 (UMLS CUI [1,4])
C1519255 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C1709863 (UMLS CUI [2,3])
C0243088 (UMLS CUI [2,4])
C3899439 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0332162 (UMLS CUI [1,4])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0332162 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C2826626 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0085978 (UMLS CUI [2,2])
C2700391 (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])
C0332197 (UMLS CUI [5,1])
C0304229 (UMLS CUI [5,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1519255 (UMLS CUI-2)
C0518690 (UMLS CUI-3)
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C2985911 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C2985911 (UMLS CUI [2])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1705232 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C1517874 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3,1])
C0745041 (UMLS CUI [3,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0231170 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3,1])
C3176592 (UMLS CUI [3,2])
C1519255 (UMLS CUI [1,2])
C0000768 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1710056 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C1320716 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0267792 (UMLS CUI [3,1])
C1519255 (UMLS CUI [3,2])
C1519255 (UMLS CUI-2)
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C2826923 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C1519255 (UMLS CUI-4)
C2347946 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C2826923 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0574845 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C1519255 (UMLS CUI [2,4])
C2347946 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,5])
C1519255 (UMLS CUI [1,6])
C2347946 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
C1519255 (UMLS CUI [2,4])
C2347946 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
C2347946 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,2])
C2826641 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0587081 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C2826705 (UMLS CUI [1,3])
C1518030 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C2826705 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2347900 (UMLS CUI [1,4])
C0687676 (UMLS CUI [1,5])
C0457454 (UMLS CUI [1,6])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C3887242 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])