ID
41824
Beschreibung
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
Stichworte
Versionen (1)
- 23.01.21 23.01.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
23. Januar 2021
DOI
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Lizenz
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
Beschreibung
Type of Report
Alias
- UMLS CUI-1
- C0585733
Beschreibung
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beschreibung
Serious Adverse Event Entry
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term on,y
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Condition Item. Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Datentyp
partialDatetime
Maßeinheiten
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beschreibung
SAE Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschreibung
End time is optional.
Datentyp
partialDatetime
Maßeinheiten
- 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
Beschreibung
End time is optional.
Datentyp
partialDatetime
Maßeinheiten
- 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
Beschreibung
SAE Date and Time of Death
Datentyp
partialDatetime
Maßeinheiten
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3899439
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0332162
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
- UMLS CUI [1,4]
- C0332162
Beschreibung
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
Datentyp
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
Beschreibung
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
Datentyp
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
Beschreibung
SAE Action taken with study treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Beschreibung
Patient withdrawn from trial because of SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
HH:MM Item is not required, hidden. If AE start and end time are used this item must be hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschreibung
HH:MM Item is not required, hidden. This item is optional.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
- UMLS CUI [1,3]
- C0946444
Beschreibung
SAE caused by study participation, procedures, blood draws, washout; investigational product absent
Datentyp
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
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1]
- C1710056
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beschreibung
Intensity Changes
Alias
- UMLS CUI-1
- C1710066
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0518690
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
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
Datentyp
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
Beschreibung
Item is not required, hidden
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0518690
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2985911
- UMLS CUI [1,3]
- C0449719
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0449719
- UMLS CUI [2]
- C2985911
Beschreibung
Seriousness
Alias
- UMLS CUI-1
- C1710056
- UMLS CUI-2
- C1519255
Beschreibung
SAE seriousness: Results in death
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1705232
- UMLS CUI [2,2]
- C1519255
Beschreibung
SAE seriousness: Is life-threatening
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1517874
- UMLS CUI [2,2]
- C1519255
Beschreibung
SAE seriousness: Requires hospitalisation or prolongation of existing hospitalisation
Datentyp
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
Beschreibung
SAE seriousness: Results in disability/incapacity
Datentyp
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
Beschreibung
SAE seriousness: Congenital anomaly
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0000768
- UMLS CUI [2,2]
- C1519255
Beschreibung
SAE seriousness: Other, specify
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1710056
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1521902
Beschreibung
SAE seriousness: Cardiovascular or hepatobiliary events
Datentyp
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
Beschreibung
Relevant concomitant/treatment medications Entry
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1519255
Beschreibung
Item is not required, hidden
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C2348184
Beschreibung
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826302
- UMLS CUI [1,4]
- C0013227
Beschreibung
Item is not required
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0869039
- UMLS CUI [1,4]
- C0013227
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0869039
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C3476109
- UMLS CUI [1,4]
- C0013227
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0013227
Beschreibung
day month year. Item is not required
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0808070
- UMLS CUI [1,4]
- C0013227
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0549178
- UMLS CUI [1,4]
- C0013227
Beschreibung
Item is not required
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0806020
Beschreibung
Enter a medical diagnosis not description. Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C0013227
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826923
Beschreibung
SAE relevant Drug type
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0457591
- UMLS CUI [1,4]
- C0013227
Beschreibung
Relevant Medical Conditions/Risk Factors Entry
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C2347946
- UMLS CUI-4
- C1519255
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2348184
- UMLS CUI [1,4]
- C0262926
Beschreibung
Enter a medical diagnosis not description.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C2348235
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826923
Beschreibung
Item is not required
Datentyp
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
Beschreibung
Item not required.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C0549178
Beschreibung
Item not required.
Datentyp
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
Beschreibung
Item is not required, hidden
Datentyp
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
Beschreibung
Relevant diagnostic results Entry
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0430022
- UMLS CUI-4
- C0456984
Beschreibung
Item is not required, hidden
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0022885
- UMLS CUI [1,4]
- C2348184
Beschreibung
Only allow site to choose from List of Values.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0022885
Beschreibung
SAE relevant Laboratory Test Date
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826641
Beschreibung
SAE relevant Laboratory Test Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C0587081
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519795
- UMLS CUI [1,4]
- C0587081
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826705
- UMLS CUI [1,4]
- C1518030
Beschreibung
Item is not required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C2826705
- UMLS CUI [1,4]
- C1519815
Beschreibung
Item is not required
Datentyp
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
Beschreibung
Rechallenge
Alias
- UMLS CUI-1
- C2347900
Beschreibung
Recurrence of SAE after experimental drug rechallenge post discontinuation
Datentyp
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
Beschreibung
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beschreibung
Item is not required.
Datentyp
text
Alias
- UMLS CUI [1]
- C0304229
Beschreibung
Time is optional. Item is not required.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
Time is optional. Item is not required.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
Optional Item: This item may be hidden. Item is not required.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0304229
Beschreibung
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Beschreibung
Non Clinical
Alias
- UMLS CUI-2
- C1298908
- UMLS CUI-1
- C0205210
Beschreibung
This item is optional. Item is not required, hidden.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beschreibung
Item is not required, hidden
Datentyp
partialDatetime
Maßeinheiten
- 24-hour clock
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1511726
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1]
- C1710056
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1511726
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C3887242
Beschreibung
Item is not required, hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0013849
Ähnliche Modelle
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])