ID
41824
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00821054
Nyckelord
Versioner (1)
- 2021-01-23 2021-01-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 januari 2021
DOI
För en begäran logga in.
Licens
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
Beskrivning
Type of Report
Alias
- UMLS CUI-1
- C0585733
Beskrivning
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beskrivning
Serious Adverse Event Entry
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term on,y
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Condition Item. Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Datatyp
partialDatetime
Måttenheter
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beskrivning
SAE Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
End time is optional.
Datatyp
partialDatetime
Måttenheter
- 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
Beskrivning
End time is optional.
Datatyp
partialDatetime
Måttenheter
- 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
Beskrivning
SAE Date and Time of Death
Datatyp
partialDatetime
Måttenheter
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3899439
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0332162
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
- UMLS CUI [1,4]
- C0332162
Beskrivning
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
Datatyp
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
Beskrivning
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
Datatyp
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
Beskrivning
SAE Action taken with study treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Beskrivning
Patient withdrawn from trial because of SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
HH:MM Item is not required, hidden. If AE start and end time are used this item must be hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beskrivning
HH:MM Item is not required, hidden. This item is optional.
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
- UMLS CUI [1,3]
- C0946444
Beskrivning
SAE caused by study participation, procedures, blood draws, washout; investigational product absent
Datatyp
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
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beskrivning
Intensity Changes
Alias
- UMLS CUI-1
- C1710066
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0518690
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
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
Datatyp
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
Beskrivning
Item is not required, hidden
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0518690
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2985911
- UMLS CUI [1,3]
- C0449719
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0449719
- UMLS CUI [2]
- C2985911
Beskrivning
Seriousness
Alias
- UMLS CUI-1
- C1710056
- UMLS CUI-2
- C1519255
Beskrivning
SAE seriousness: Results in death
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1705232
- UMLS CUI [2,2]
- C1519255
Beskrivning
SAE seriousness: Is life-threatening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1517874
- UMLS CUI [2,2]
- C1519255
Beskrivning
SAE seriousness: Requires hospitalisation or prolongation of existing hospitalisation
Datatyp
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
Beskrivning
SAE seriousness: Results in disability/incapacity
Datatyp
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
Beskrivning
SAE seriousness: Congenital anomaly
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0000768
- UMLS CUI [2,2]
- C1519255
Beskrivning
SAE seriousness: Other, specify
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1710056
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1521902
Beskrivning
SAE seriousness: Cardiovascular or hepatobiliary events
Datatyp
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
Beskrivning
Relevant concomitant/treatment medications Entry
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1519255
Beskrivning
Item is not required, hidden
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C2348184
Beskrivning
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826302
- UMLS CUI [1,4]
- C0013227
Beskrivning
Item is not required
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0869039
- UMLS CUI [1,4]
- C0013227
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0869039
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C3476109
- UMLS CUI [1,4]
- C0013227
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0013227
Beskrivning
day month year. Item is not required
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0808070
- UMLS CUI [1,4]
- C0013227
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0549178
- UMLS CUI [1,4]
- C0013227
Beskrivning
Item is not required
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0806020
Beskrivning
Enter a medical diagnosis not description. Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C0013227
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826923
Beskrivning
SAE relevant Drug type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0457591
- UMLS CUI [1,4]
- C0013227
Beskrivning
Relevant Medical Conditions/Risk Factors Entry
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C2347946
- UMLS CUI-4
- C1519255
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2348184
- UMLS CUI [1,4]
- C0262926
Beskrivning
Enter a medical diagnosis not description.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C2348235
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826923
Beskrivning
Item is not required
Datatyp
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
Beskrivning
Item not required.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C0549178
Beskrivning
Item not required.
Datatyp
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
Beskrivning
Item is not required, hidden
Datatyp
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
Beskrivning
Relevant diagnostic results Entry
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0430022
- UMLS CUI-4
- C0456984
Beskrivning
Item is not required, hidden
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0022885
- UMLS CUI [1,4]
- C2348184
Beskrivning
Only allow site to choose from List of Values.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0022885
Beskrivning
SAE relevant Laboratory Test Date
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826641
Beskrivning
SAE relevant Laboratory Test Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0587081
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519795
- UMLS CUI [1,4]
- C0587081
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826705
- UMLS CUI [1,4]
- C1518030
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826705
- UMLS CUI [1,4]
- C1519815
Beskrivning
Item is not required
Datatyp
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
Beskrivning
Rechallenge
Alias
- UMLS CUI-1
- C2347900
Beskrivning
Recurrence of SAE after experimental drug rechallenge post discontinuation
Datatyp
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
Beskrivning
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Item is not required.
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Time is optional. Item is not required.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
Time is optional. Item is not required.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
Optional Item: This item may be hidden. Item is not required.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0304229
Beskrivning
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Beskrivning
Non Clinical
Alias
- UMLS CUI-2
- C1298908
- UMLS CUI-1
- C0205210
Beskrivning
This item is optional. Item is not required, hidden.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beskrivning
Item is not required, hidden
Datatyp
partialDatetime
Måttenheter
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1511726
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1511726
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
Item is not required, hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C3887242
Beskrivning
Item is not required, hidden
Datatyp
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])