ID
41304
Beskrivning
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast
Nyckelord
Versioner (1)
- 2020-08-13 2020-08-13 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
13 augusti 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275
Logs/Repeats
- StudyEvent: ODM
Beskrivning
ECHO/MUGA
Alias
- UMLS CUI-1
- C0013516
- UMLS CUI-2
- C0521317
Beskrivning
Echocardiography, Multiple gated acquisition scanning, Ejection fraction (finding), Lower Limit of Normal
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0521317
- UMLS CUI [1,3]
- C2700378
- UMLS CUI [1,4]
- C1518030
Beskrivning
Echocardiography, Multiple gated acquisition scanning
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0521317
Beskrivning
Echocardiography, Multiple gated acquisition scanning, Date in time, Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0521317
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beskrivning
Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0521317
- UMLS CUI [1,3]
- C0428772
Beskrivning
Echocardiography, Multiple gated acquisition scanning, Left ventricular ejection fraction
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0521317
- UMLS CUI [1,3]
- C0428772
Beskrivning
Echocardiography, Multiple gated acquisition scanning, Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0521317
- UMLS CUI [1,3]
- C1274040
Beskrivning
Echocardiography, Multiple gated acquisition scanning, Abnormality
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0521317
- UMLS CUI [1,3]
- C1704258
Beskrivning
Vital Signs - Repeating Form
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0205341
Beskrivning
Vital signs, Date in time, Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beskrivning
Body Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Heart rate while sitting
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C2029904
Beskrivning
Systolic Pressure, Sitting position
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beskrivning
Diastolic blood pressure, Sitting position
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beskrivning
Unscheduled 12-Lead ECG - Repeating Form
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C3854240
- UMLS CUI-3
- C0205341
Beskrivning
12 lead ECG, Date in time, Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beskrivning
12 lead ECG, Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Beskrivning
12 lead ECG, Electrocardiogram: P-R interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beskrivning
12 lead ECG, QRS complex duration
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beskrivning
12 lead ECG, QT interval - finding
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beskrivning
12 lead ECG, Electrocardiogram QT corrected interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beskrivning
12 lead ECG, Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beskrivning
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beskrivning
12 lead ECG, Abnormality, Date in time, Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beskrivning
12 lead ECG, Abnormality
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
Beskrivning
Unscheduled Pharmacokinetics Samples (PK) - Repeating Form
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C3854240
- UMLS CUI-3
- C0205341
Beskrivning
Pharmacokinetic aspects, Sample identification number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C1299222
Beskrivning
Pharmacokinetic aspects, Date in time, Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beskrivning
Investigational Product - GSK1120212 Unscheduled (Study Drug) - Repeating Form
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3854240
- UMLS CUI-3
- C0205341
Beskrivning
Adverse Event (AE) - Repeating Form
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0205341
Beskrivning
Adverse event, Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348184
Beskrivning
Serious Adverse Event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Serious Adverse Event, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
Beskrivning
Adverse event
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Adverse Event Modified Reported Term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826798
Beskrivning
Adverse event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1140263
Beskrivning
Adverse event, MedDRA Low Level Term Code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3898442
Beskrivning
Adverse event, Code, Failed
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beskrivning
Adverse Event Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
Adverse event, Before
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0332152
Beskrivning
Adverse Event Outcome, Adverse Event End Date
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C2697886
Beskrivning
Adverse Event End Date Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beskrivning
Adverse event, Date of death, Time of death
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1148348
- UMLS CUI [1,3]
- C1301931
Beskrivning
Adverse event, Frequencies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439603
Beskrivning
Adverse event, Symptom intensity, Onset
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0332162
Beskrivning
Adverse event, Symptom intensity, Maximum
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Adverse event, Grade, Onset
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0332162
Beskrivning
Adverse event, Grade, Maximum
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beskrivning
Adverse event, Grade, Symptom intensity, Onset
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0332162
Beskrivning
Adverse event, Grade, Symptom intensity, Maximum
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Beskrivning
Adverse event, Action Taken with Study Treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
Beskrivning
Adverse event, Action Taken with Study Treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
Beskrivning
Adverse Event, Action Taken with Study Treatment, Clinical Significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [1,3]
- C2826293
Beskrivning
Adverse event, Withdraw
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2349954
Beskrivning
Adverse event, Causations, Experimental drug
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0304229
Beskrivning
Adverse event, Causations, Experimental drug
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0304229
Beskrivning
Adverse event, Duration
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2926735
Beskrivning
Adverse event, Time of onset, Date last dose
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449244
- UMLS CUI [1,3]
- C1762893
Beskrivning
Adverse event, dose-limiting, Drug toxicity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1512043
- UMLS CUI [1,3]
- C0013221
Beskrivning
Adverse event, Therapeutic procedure, Concomitant Agent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C2347852
Beskrivning
Adverse event, Part, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0808070
Beskrivning
Adverse event, Part, Symptom intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0518690
Beskrivning
Adverse event, Part, Grade
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0441800
Beskrivning
Adverse event, Part, Grade, Symptom intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449719
- UMLS CUI [1,3]
- C0441800
- UMLS CUI [1,4]
- C0518690
Beskrivning
Adverse event, Therapeutic procedure, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0808070
Beskrivning
Adverse event, Action Taken with Study Treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
Beskrivning
Adverse event, Action Taken with Study Treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1704758
Beskrivning
Serious Adverse Event, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beskrivning
Serious Adverse Event, End date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beskrivning
Serious Adverse Events (SAE)
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event, Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Serious Adverse Event Report
Datatyp
text
Alias
- UMLS CUI [1]
- C3897642
Beskrivning
Serious Adverse Event, Report, Start Date, Start time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0684224
- UMLS CUI [1,3]
- C0808070
- UMLS CUI [1,4]
- C1301880
Beskrivning
Serious Adverse Event, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
Beskrivning
Serious Adverse Event, Causations, Activities, Study Subject Participation Status
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beskrivning
Serious Adverse Event
Datatyp
text
Beskrivning
Serious Adverse Event, Adverse Event Modified Reported Term
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Beskrivning
Serious Adverse Event, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beskrivning
Serious Adverse Event, Adverse Event Outcome
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
Serious Adverse Event, End date, End Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Beskrivning
Serious Adverse Event, Date of death, Time of death
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C1148348
- UMLS CUI [1,4]
- C1301931
Beskrivning
Serious Adverse Event, Frequencies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439603
Beskrivning
Serious Adverse Event, Symptom intensity, Maximum
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Serious Adverse Event, Grade, Maximum
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beskrivning
Serious Adverse Event, Grade, Symptom intensity, Maximum
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Beskrivning
Serious Adverse Event, Toxicity aspects, Patient History
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0040539
- UMLS CUI [1,3]
- C0679831
Beskrivning
Serious Adverse Event, Action Taken with Study Treatment, Clinical Significance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
- UMLS CUI [1,3]
- C2826293
Beskrivning
Serious Adverse Event, Action Taken with Study Treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Beskrivning
Serious Adverse Event, Withdraw
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Beskrivning
Serious Adverse Event, Investigational New Drugs, Relationships
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Serious Adverse Event, Duration
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2926735
Beskrivning
Serious Adverse Event, Time of onset, Time last dose
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
- UMLS CUI [1,3]
- C0946444
Beskrivning
Serious Adverse Event, Dose-limiting, Drug toxicity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1512043
- UMLS CUI [1,3]
- C0013221
Beskrivning
Serious Adverse Event, Part
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449719
Beskrivning
Serious Adverse Event, Concomitant Agent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
Beskrivning
Serious Adverse Event, Concomitant Agent, Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2348184
Beskrivning
Serious Adverse Event, Concomitant Agent, Medication name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beskrivning
Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826819
Beskrivning
Serious Adverse Event, Concomitant Agent, Medication name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beskrivning
Serious Adverse Event, Concomitant Agent, Dosage
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0178602
Beskrivning
Serious Adverse Event, Concomitant Agent, Unit of Measure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Beskrivning
Serious Adverse Event, Concomitant Agent, Frequencies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Beskrivning
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beskrivning
Serious Adverse Event, Concomitant Agent, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0566251
Beskrivning
Serious Adverse Event, Concomitant Agent, Concomitant Medication Modified Reported Term, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826819
- UMLS CUI [1,4]
- C0566251
Beskrivning
Serious Adverse Event, Concomitant Agent, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Beskrivning
Serious Adverse Event, Concomitant Agent, Concomitant Medication Ongoing
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2826666
Beskrivning
Serious Adverse Event, Concomitant Agent, End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Beskrivning
Serious Adverse Event, Concomitant Agent, Duration
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0449238
Beskrivning
Serious Adverse Event, Concomitant Agent, Duration, Unit of Measure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0449238
- UMLS CUI [1,4]
- C1519795
Beskrivning
Serious Adverse Event, Experimental drug, Initiation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1704686
Beskrivning
Serious Adverse Event, Randomization, Numbers
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0237753
Beskrivning
Serious Adverse Event, Disease, Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C2348184
Beskrivning
Serious Adverse Event, Disease
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C2348184
Beskrivning
Serious Adverse Event, Disease, Adverse Event Modified Reported Term
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C2826798
Beskrivning
Serious Adverse Event, Disease, Date of onset
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0574845
Beskrivning
Serious Adverse Event, Disease, Continuous
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0549178
Beskrivning
Serious Adverse Event, Disease, End date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0806020
Beskrivning
Serious Adverse Event, diagnostic procedure, Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C2348184
Beskrivning
Serious Adverse Event, diagnostic procedure, Test Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C2826273
Beskrivning
Serious Adverse Event, diagnostic procedure, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0011008
Beskrivning
Serious Adverse Event, diagnostic procedure, Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C1274040
Beskrivning
Serious Adverse Event, diagnostic procedure, Unit of Measure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C1519795
Beskrivning
Serious Adverse Event, diagnostic procedure, Normal Range, Low
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0086715
- UMLS CUI [1,4]
- C0205251
Beskrivning
Serious Adverse Event, diagnostic procedure, Normal Range, High
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0086715
- UMLS CUI [1,4]
- C0205250
Beskrivning
Serious Adverse Event, diagnostic procedure, Result, Other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C1274040
- UMLS CUI [1,4]
- C0205394
Beskrivning
Serious Adverse Event, Relationships, Experimental drug
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beskrivning
Serious Adverse Event, Experimental drug
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0808070
Beskrivning
Serious Adverse Event, Experimental drug, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0808070
Beskrivning
Serious Adverse Event, Experimental drug, End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0806020
Beskrivning
Serious Adverse Event, Experimental drug, Dosage
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
Beskrivning
Serious Adverse Event, Experimental drug, Cumulative Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2986497
Beskrivning
Serious Adverse Event, Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0947611
Beskrivning
Concomitant Medications - Repeating Form
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Concomitant Agent, Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beskrivning
Concomitant Agent, Medication name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beskrivning
Concomitant Agent, Concomitant Medication Modified Reported Term
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2826819
Beskrivning
Concomitant Agent, Code, Failed
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beskrivning
Concomitant Agent, Dosage
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0178602
Beskrivning
Concomitant Agent, Unit of Measure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Beskrivning
Concomitant Agent, Frequencies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0439603
Beskrivning
Concomitant Agent, Drug Administration Routes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Beskrivning
Concomitant Agent, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0566251
Beskrivning
Concomitant Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Concomitant Medication Previous Occurrence
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
Concomitant Medication Ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Concomitant Medication End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Concomitant Agent, Devices, Medication administered
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0699733
- UMLS CUI [1,3]
- C0806914
Beskrivning
Concomitant Agent, Daily Dose, Total
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Beskrivning
Concomitant Agent, Disease Exacerbation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0235874
Beskrivning
Concomitant Agent, Rescue remedy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0884980
Beskrivning
Concomitant Agent, Cumulative Dose
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2986497
Beskrivning
Concomitant Agent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Concomitant Agent, Duration, Total
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0449238
- UMLS CUI [1,3]
- C0439810
Beskrivning
Concomitant Agent, Duration, Unit of Measure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0449238
- UMLS CUI [1,3]
- C1519795
Similar models
Logs/Repeats
- StudyEvent: ODM
C0205341 (UMLS CUI [1,2])
C1320303 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,4])
C0205341 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C3854240 (UMLS CUI [2,2])
C3854240 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0031328 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
C3854240 (UMLS CUI [2,3])
C0521317 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0013516 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C3854240 (UMLS CUI [2,3])
C0205341 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C3854240 (UMLS CUI [2,2])
C0877248 (UMLS CUI [1,2])
C0521317 (UMLS CUI-2)
C0521317 (UMLS CUI [1,2])
C2700378 (UMLS CUI [1,3])
C1518030 (UMLS CUI [1,4])
C0521317 (UMLS CUI [1,2])
C0521317 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [1,3])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [1,3])
C0521317 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0521317 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0205341 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C1299222 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C3854240 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C3854240 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0205341 (UMLS CUI-2)
C2348184 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,2])
C1301931 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0332162 (UMLS CUI [1,4])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C1704758 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2926735 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
C1512043 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1704758 (UMLS CUI [1,2])
C1704758 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C2826798 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,3])
C1301931 (UMLS CUI [1,4])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C0040539 (UMLS CUI [1,2])
C0679831 (UMLS CUI [1,3])
C1704758 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C1704758 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C2926735 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
C1512043 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C2826273 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0699733 (UMLS CUI [1,2])
C0806914 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0235874 (UMLS CUI [1,2])
C0884980 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])