ID
41824
Descripción
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
Palabras clave
Versiones (1)
- 23/1/21 23/1/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de enero de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Type of Report
Alias
- UMLS CUI-1
- C0585733
Descripción
Randomisation
Alias
- UMLS CUI-1
- C0034656
Descripción
Serious Adverse Event Entry
Alias
- UMLS CUI-1
- C1519255
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term on,y
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descripción
Condition Item. Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Tipo de datos
partialDatetime
Unidades de medida
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Descripción
SAE Outcome
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Descripción
End time is optional.
Tipo de datos
partialDatetime
Unidades de medida
- 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
Descripción
End time is optional.
Tipo de datos
partialDatetime
Unidades de medida
- 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
Descripción
SAE Date and Time of Death
Tipo de datos
partialDatetime
Unidades de medida
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3899439
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0332162
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
- UMLS CUI [1,4]
- C0332162
Descripción
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
Tipo de datos
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
Descripción
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
Tipo de datos
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
Descripción
SAE Action taken with study treatment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Descripción
Patient withdrawn from trial because of SAE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
HH:MM Item is not required, hidden. If AE start and end time are used this item must be hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Descripción
HH:MM Item is not required, hidden. This item is optional.
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
- UMLS CUI [1,3]
- C0946444
Descripción
SAE caused by study participation, procedures, blood draws, washout; investigational product absent
Tipo de datos
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
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710056
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Descripción
Intensity Changes
Alias
- UMLS CUI-1
- C1710066
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0518690
Descripción
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
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
Tipo de datos
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
Descripción
Item is not required, hidden
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0518690
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2985911
- UMLS CUI [1,3]
- C0449719
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0449719
- UMLS CUI [2]
- C2985911
Descripción
Seriousness
Alias
- UMLS CUI-1
- C1710056
- UMLS CUI-2
- C1519255
Descripción
SAE seriousness: Results in death
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1705232
- UMLS CUI [2,2]
- C1519255
Descripción
SAE seriousness: Is life-threatening
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1517874
- UMLS CUI [2,2]
- C1519255
Descripción
SAE seriousness: Requires hospitalisation or prolongation of existing hospitalisation
Tipo de datos
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
Descripción
SAE seriousness: Results in disability/incapacity
Tipo de datos
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
Descripción
SAE seriousness: Congenital anomaly
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0000768
- UMLS CUI [2,2]
- C1519255
Descripción
SAE seriousness: Other, specify
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1710056
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1521902
Descripción
SAE seriousness: Cardiovascular or hepatobiliary events
Tipo de datos
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
Descripción
Relevant concomitant/treatment medications Entry
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1519255
Descripción
Item is not required, hidden
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C2348184
Descripción
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826302
- UMLS CUI [1,4]
- C0013227
Descripción
Item is not required
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0869039
- UMLS CUI [1,4]
- C0013227
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0869039
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C3476109
- UMLS CUI [1,4]
- C0013227
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0013227
Descripción
day month year. Item is not required
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0808070
- UMLS CUI [1,4]
- C0013227
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0549178
- UMLS CUI [1,4]
- C0013227
Descripción
Item is not required
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0806020
Descripción
Enter a medical diagnosis not description. Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C0013227
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826923
Descripción
SAE relevant Drug type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0457591
- UMLS CUI [1,4]
- C0013227
Descripción
Relevant Medical Conditions/Risk Factors Entry
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C2347946
- UMLS CUI-4
- C1519255
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2348184
- UMLS CUI [1,4]
- C0262926
Descripción
Enter a medical diagnosis not description.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C2348235
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826923
Descripción
Item is not required
Tipo de datos
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
Descripción
Item not required.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C0549178
Descripción
Item not required.
Tipo de datos
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
Descripción
Item is not required, hidden
Tipo de datos
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
Descripción
Relevant diagnostic results Entry
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0430022
- UMLS CUI-4
- C0456984
Descripción
Item is not required, hidden
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0022885
- UMLS CUI [1,4]
- C2348184
Descripción
Only allow site to choose from List of Values.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0022885
Descripción
SAE relevant Laboratory Test Date
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826641
Descripción
SAE relevant Laboratory Test Result
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0587081
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519795
- UMLS CUI [1,4]
- C0587081
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826705
- UMLS CUI [1,4]
- C1518030
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826705
- UMLS CUI [1,4]
- C1519815
Descripción
Item is not required
Tipo de datos
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
Descripción
Rechallenge
Alias
- UMLS CUI-1
- C2347900
Descripción
Recurrence of SAE after experimental drug rechallenge post discontinuation
Tipo de datos
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
Descripción
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Descripción
Item is not required.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0304229
Descripción
Time is optional. Item is not required.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Descripción
Time is optional. Item is not required.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Descripción
Optional Item: This item may be hidden. Item is not required.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0304229
Descripción
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Descripción
Non Clinical
Alias
- UMLS CUI-2
- C1298908
- UMLS CUI-1
- C0205210
Descripción
This item is optional. Item is not required, hidden.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Descripción
Item is not required, hidden
Tipo de datos
partialDatetime
Unidades de medida
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1511726
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710056
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1511726
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Descripción
Item is not required, hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C3887242
Descripción
Item is not required, hidden
Tipo de datos
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])