ID

41824

Description

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

Keywords

Versions (1)
  1. 1/23/21 1/23/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 23, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

English

Serious Adverse Events (SAE)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Type of Report
Description

Type of Report

Alias
UMLS CUI-1
C0585733
Initial Report
Description

Item is not required, hidden

Data type

integer

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0205265
Follow-Up Report
Description

Item is not required, hidden

Data type

integer

Alias
UMLS CUI [1]
C1704685
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Description

Did SAE occur after initiation of study medication?

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1704686
Serious Adverse Event Entry
Description

Serious Adverse Event Entry

Alias
UMLS CUI-1
C1519255
SAE Sequence number
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term on,y

Data type

text

Alias
UMLS CUI [1]
C1519255
Modified term
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
MedDRA synonym
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
MedDRA lower level term code
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
Failed coding
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Serious Adverse Event Start Date and Time
Description

Condition Item. Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.

Data type

partialDatetime

Measurement units
  • 24-hour clock
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1301880
24-hour clock
Serious Adverse Event Outcome
Description

SAE Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
If recovered/Resolved, provide End Date and Time
Description

End time is optional.

Data type

partialDatetime

Measurement units
  • 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
24-hour clock
If recovered/Resolved with sequelae, provide End Date and Time
Description

End time is optional.

Data type

partialDatetime

Measurement units
  • 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
24-hour clock
If Fatal, record Date and Time of Death
Description

SAE Date and Time of Death

Data type

partialDatetime

Measurement units
  • 24-hour clock
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3899439
24-hour clock
Maximum Intensity
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Intensity at onset of event
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0332162
Maximum Grade of Serious Adverse Event
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0441800
Grade at onset of event
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0441800
UMLS CUI [1,4]
C0332162
Maximum Grade or Intensity of Serious Adverse Event
Description

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

Data type

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
Grade or Intensity at onset of event
Description

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

Data type

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
Action taken with Investigational Product(s) as a result of AE?
Description

SAE Action taken with study treatment

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826626
Did the subject withdraw from the study as a result of AE?
Description

Patient withdrawn from trial because of SAE

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of AE if < 24 hours
Description

HH:MM Item is not required, hidden. If AE start and end time are used this item must be hidden.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Time to Onset since last Dose
Description

HH:MM Item is not required, hidden. This item is optional.

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C0946444
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
Description

SAE caused by study participation, procedures, blood draws, washout; investigational product absent

Data type

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
Was the event serious?
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1]
C1710056
Related Investigational Product
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Intensity Changes
Description

Intensity Changes

Alias
UMLS CUI-1
C1710066
UMLS CUI-2
C1519255
UMLS CUI-3
C0518690
Serious Adverse Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

Data type

text

Alias
UMLS CUI [1]
C1519255
Start Date and Time of event segment
Description

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

Data type

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
Intensity of event segment
Description

Item is not required, hidden

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
Grade of event segment
Description

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.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985911
UMLS CUI [1,3]
C0449719
Grade or Intensity of event segment
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0449719
UMLS CUI [2]
C2985911
Seriousness
Description

Seriousness

Alias
UMLS CUI-1
C1710056
UMLS CUI-2
C1519255
Seriousness? [A] Results in death
Description

SAE seriousness: Results in death

Data type

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C1705232
UMLS CUI [2,2]
C1519255
Seriousness? [B] Is life-threatening
Description

SAE seriousness: Is life-threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C1517874
UMLS CUI [2,2]
C1519255
Seriousness? [C] Requires hospitalisation or prolongation of existing hospitalisation
Description

SAE seriousness: Requires hospitalisation or prolongation of existing hospitalisation

Data type

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
Seriousness? [D] Results in disability/incapacity
Description

SAE seriousness: Results in disability/incapacity

Data type

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
Seriousness? [E] Congenital anomaly/birth defect
Description

SAE seriousness: Congenital anomaly

Data type

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0000768
UMLS CUI [2,2]
C1519255
Seriousness? [F] Other, specify within general narrative comment
Description

SAE seriousness: Other, specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1710056
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1521902
Seriousness? [G] Cardiovascular or hepatobiliary events (Refer to Section 12.2.1 of the Protocol.)
Description

SAE seriousness: Cardiovascular or hepatobiliary events

Data type

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
Relevant concomitant/treatment medications Entry
Description

Relevant concomitant/treatment medications Entry

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1519255
CM Sequence number
Description

Item is not required, hidden

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C2348184
Drug name
Description

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0013227
Modified reported term
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C2826302
UMLS CUI [1,4]
C0013227
Drug Dose
Description

Item is not required

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0869039
UMLS CUI [1,4]
C0013227
Dose unit
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0869039
Frequency
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C3476109
UMLS CUI [1,4]
C0013227
Route
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0013227
Date started
Description

day month year. Item is not required

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0808070
UMLS CUI [1,4]
C0013227
Ongoing?
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0013227
If not ongoing, specify End Date
Description

Item is not required

Data type

partialDate

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0806020
Primary indication
Description

Enter a medical diagnosis not description. Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C0013227
Modified reported term
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C2826923
Drug type
Description

SAE relevant Drug type

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0457591
UMLS CUI [1,4]
C0013227
Relevant Medical Conditions/Risk Factors Entry
Description

Relevant Medical Conditions/Risk Factors Entry

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C0012634
UMLS CUI-3
C2347946
UMLS CUI-4
C1519255
MHx Sequence Number
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C2348184
UMLS CUI [1,4]
C0262926
Specific Condition Name
Description

Enter a medical diagnosis not description.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C2348235
Modified reported term
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C2826923
Date of onset
Description

Item is not required

Data type

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
Is medical condition continuing?
Description

Item not required.

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C0549178
If NO, specify date of last occurrence
Description

Item not required.

Data type

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
Relevant Medical History / Risk Factors not noted above
Description

Item is not required, hidden

Data type

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
Relevant diagnostic results Entry
Description

Relevant diagnostic results Entry

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347946
UMLS CUI-3
C0430022
UMLS CUI-4
C0456984
Lab Sequence Number
Description

Item is not required, hidden

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0022885
UMLS CUI [1,4]
C2348184
Test Name
Description

Only allow site to choose from List of Values.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0022885
Test Date
Description

SAE relevant Laboratory Test Date

Data type

partialDate

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C2826641
Test Result
Description

SAE relevant Laboratory Test Result

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0587081
Test Units
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C1519795
UMLS CUI [1,4]
C0587081
Normal Low Range
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C2826705
UMLS CUI [1,4]
C1518030
Normal High Range
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C2826705
UMLS CUI [1,4]
C1519815
Relevant diagnostic results not noted above
Description

Item is not required

Data type

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
Rechallenge
Description

Rechallenge

Alias
UMLS CUI-1
C2347900
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Description

Recurrence of SAE after experimental drug rechallenge post discontinuation

Data type

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
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Study Drug
Description

Item is not required.

Data type

text

Alias
UMLS CUI [1]
C0304229
Study Drug Start Date
Description

Time is optional. Item is not required.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Study Drug Stop Date
Description

Time is optional. Item is not required.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Regimen
Description

Optional Item: This item may be hidden. Item is not required.

Data type

text

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0304229
General narrative comments
Description

General narrative comments

Alias
UMLS CUI-1
C0947611
General narrative comments
Description

General narrative comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Non Clinical
Description

Non Clinical

Alias
UMLS CUI-2
C1298908
UMLS CUI-1
C0205210
Send incomplete SAE data to GSK Safety
Description

This item is optional. Item is not required, hidden.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0205257
Receipt by GSK date
Description

Item is not required, hidden

Data type

partialDatetime

Measurement units
  • 24-hour clock
Alias
UMLS CUI [1,1]
C2985846
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C1511726
24-hour clock
Was the event serious?
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1]
C1710056
SAE Sequence number
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C0333052
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1511726
Case ID
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C3887242
Email Flag
Description

Item is not required, hidden

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0013849
Back to the top of the page

Similar models

Serious Adverse Events (SAE)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Type of Report
C0585733 (UMLS CUI-1)
Item
Initial Report
integer
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Initial Report
Code List
Initial Report
CL Item
Initial (1)
Item
Follow-Up Report
integer
C1704685 (UMLS CUI [1])
Follow-Up Report
Code List
Follow-Up Report
CL Item
Follow-Up (2)
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Item
Did SAE occur after initiation of study medication?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
Did SAE occur after initiation of study medication?
Code List
Did SAE occur after initiation of study medication?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Serious Adverse Event Entry
C1519255 (UMLS CUI-1)
SAE Sequence number
Item
SAE Sequence number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse event
Item
Serious Adverse event
text
C1519255 (UMLS CUI [1])
Serious Adverse event, Modified term
Item
Modified term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
SAE MedDRA synonym
Item
MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
SAE MedDRA lower level term code
Item
MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
SAE Start Date and Time
Item
Serious Adverse Event Start Date and Time
partialDatetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Item
Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Serious Adverse Event Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
SAE End Date and Time if Recovered/Resolved
Item
If recovered/Resolved, provide End Date and Time
partialDatetime
C1519255 (UMLS CUI [1,1])
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])
SAE End Date and Time if Recovered/Resolved with sequelae
Item
If recovered/Resolved with sequelae, provide End Date and Time
partialDatetime
C1519255 (UMLS CUI [1,1])
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])
SAE Date and Time of Death
Item
If Fatal, record Date and Time of Death
partialDatetime
C1519255 (UMLS CUI [1,1])
C3899439 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Intensity at onset of event
Code List
Intensity at onset of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Maximum Grade of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Maximum Grade
Code List
Maximum Grade of Serious Adverse Event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade at onset of event
integer
C1519255 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0332162 (UMLS CUI [1,4])
Grade at onset of event
Code List
Grade at onset of event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Maximum Grade or Intensity of Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
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])
Maximum Grade of Intensity
Code List
Maximum Grade or Intensity of Serious Adverse Event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Grade or Intensity at onset of event
text
C0518690 (UMLS CUI [1,1])
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])
Grade of Intensity at onset of event
Code List
Grade or Intensity at onset of event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action taken with Investigational Product(s) as a result of AE?
text
C1519255 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Action taken with Investigational Product(s) as a result of AE?
Code List
Action taken with Investigational Product(s) as a result of AE?
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from the study as a result of AE?
text
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Did the subject withdraw from the study as a result of AE?
Code List
Did the subject withdraw from the study as a result of AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Duration of SAE if < 24 hours
Item
Duration of AE if < 24 hours
text
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
SAE Time to Onset since last Dose
Item
Time to Onset since last Dose
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
text
C1519255 (UMLS CUI [1,1])
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])
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
Code List
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the event serious?
text
C1710056 (UMLS CUI [1])
Was the event serious?
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
SAE Related Investigational Product
Item
Related Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Intensity Changes
C1710066 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0518690 (UMLS CUI-3)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Start Date and Time of SAE segment
Item
Start Date and Time of event segment
partialDatetime
C1519255 (UMLS CUI [1,1])
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])
Item
Intensity of event segment
integer
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Intensity (maximum)
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
integer
C1519255 (UMLS CUI [1,1])
C2985911 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
Grade of event segment
Code List
Grade of event segment
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade or Intensity of event segment
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C2985911 (UMLS CUI [2])
Grade or Intensity of event segment
Code List
Grade or Intensity of event segment
CL Item
Mild or Grade l (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade4 (4)
CL Item
Grade 5 (5)
Item Group
Seriousness
C1710056 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
SAE seriousness: Results in death
Item
Seriousness? [A] Results in death
boolean
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1705232 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
SAE seriousness: Is life-threatening
Item
Seriousness? [B] Is life-threatening
boolean
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1517874 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
SAE seriousness: Requires hospitalisation or prolongation of existing hospitalisation
Item
Seriousness? [C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1710056 (UMLS CUI [1,1])
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])
SAE seriousness: Results in disability/incapacity
Item
Seriousness? [D] Results in disability/incapacity
boolean
C1710056 (UMLS CUI [1,1])
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])
SAE seriousness: Congenital anomaly
Item
Seriousness? [E] Congenital anomaly/birth defect
boolean
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0000768 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
SAE seriousness: Other, specify
Item
Seriousness? [F] Other, specify within general narrative comment
boolean
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
SAE seriousness: Cardiovascular or hepatobiliary events
Item
Seriousness? [G] Cardiovascular or hepatobiliary events (Refer to Section 12.2.1 of the Protocol.)
boolean
C1710056 (UMLS CUI [1,1])
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])
Item Group
Relevant concomitant/treatment medications Entry
C0013227 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
SAE relevant Medication Sequence number
Item
CM Sequence number
integer
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
SAE relevant Drug name
Item
Drug name
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
SAE relevant Modified reported term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
SAE relevant Drug Dose
Item
Drug Dose
integer
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Item
Dose unit
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,3])
Dose unit
Code List
Dose unit
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (AP)
CL Item
Bottle (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Drops (031)
CL Item
Gram (002)
CL Item
International units (025)
CL Item
International units per kilogram (028)
CL Item
International units per millilitre (IUML)
CL Item
Litre (011)
CL Item
Litre per minute (LM)
CL Item
Lozenge (LOZ)
CL Item
Megaunits (million units) (MEGU)
CL Item
Microgram (UG) (004)
CL Item
Microgram (UG) (004)
CL Item
Microgram/kilogram (008)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Microlitre (013)
CL Item
Milliequivalent (029)
CL Item
Milliequivalent per 24 hours (MEQ24)
CL Item
Milligram (003)
CL Item
Milligrams percent (MGPER)
CL Item
Milligram per hour (MGH)
CL Item
Milligram/kilogram (007)
CL Item
Milligram/kilogram per hour (MGKH)
CL Item
Milligram/kilogram per minute (MGKM)
CL Item
Milligram/metre squared (009)
CL Item
Milligram/millilitre (MGML)
CL Item
Millilitre (012)
CL Item
Millilitre per hour (MLH)
CL Item
Millilitre per minute (MLM)
CL Item
Millimole (023)
CL Item
Million International units (027)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nebule (NEB)
CL Item
Patch (PAT)
CL Item
Percent (030)
CL Item
Puff (PUFF)
CL Item
Sachet (SAC)
CL Item
Spray (SPR)
CL Item
Suppository (SUP)
CL Item
Tablespoon (TBS)
CL Item
Tablet (TAB)
CL Item
Teaspoon (TSP)
CL Item
Units (UNT)
CL Item
Unknown (U)
CL Item
Vial (VIA)
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Frequency
Code List
Frequency
CL Item
2 times per week (2W)
CL Item
3 times per week (3W)
CL Item
4 times per week (4W)
CL Item
5 times per day (5D)
CL Item
5 times per week (5W)
CL Item
AC (AC)
CL Item
Q12H (2D)
CL Item
Continuous infusion (CO)
CL Item
Every 2 weeks (FO)
CL Item
Every 3 weeks (Q3WK)
CL Item
Every 3 months (Q3M)
CL Item
Every other day (AD)
CL Item
QPM (1N)
CL Item
Once a month (MO)
CL Item
Once a week (WE)
CL Item
Once daily (1D)
CL Item
Once only (1S)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q2H (12D)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
Q4H (6D)
CL Item
QID (4D)
CL Item
TID (3D)
CL Item
Q12H (2D)
CL Item
QAM (1M)
CL Item
QH (24D)
CL Item
QID (4D)
CL Item
QPM (1N)
CL Item
TID (3D)
CL Item
Unknown (U)
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Route
Code List
Route
CL Item
Both eyes (047)
CL Item
Epidural (008)
CL Item
Gastrostomy tube (GT)
CL Item
Inhalation (055)
CL Item
Injection (INJ)
CL Item
Intra-arterial (013)
CL Item
Intra-bursa (IBU)
CL Item
Intralesional (026)
CL Item
Intramuscular (030)
CL Item
Nasal (045)
CL Item
Intraocular (031)
CL Item
lntraosteal (IOS)
CL Item
Intraperitoneal (033)
CL Item
Intrathecal (037)
CL Item
Intrauterine (015)
CL Item
Intravenous (042)
CL Item
Nasal (045)
CL Item
Oral (048)
CL Item
Rectal (054)
CL Item
Subcutaneous (058)
CL Item
Sublingual (060)
CL Item
Topical (061)
CL Item
Transdermal (062)
CL Item
Unknown (065)
CL Item
Vaginal (067)
SAE relevant medication Start Date
Item
Date started
date
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Item
Ongoing?
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Ongoing
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No, specify End Date (N)
SAE relevant Medication End Date
Item
If not ongoing, specify End Date
partialDate
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Primary indication of SAE relevant medication
Item
Primary indication
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
SAE relevant Modified reported term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2826923 (UMLS CUI [1,3])
Item
Drug type
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Drug type
Code List
Drug type
CL Item
Cause of SAE (1)
CL Item
Concomitant (2)
CL Item
Treatment (T)
Item Group
Relevant Medical Conditions/Risk Factors Entry
C0035648 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C1519255 (UMLS CUI-4)
SAE relevant MHx Sequence Number
Item
MHx Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
SAE relevant Specific Condition Name
Item
Specific Condition Name
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
SAE relevant Modified reported term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2826923 (UMLS CUI [1,3])
Date of onset of risk factors or disease relevant to SAE
Item
Date of onset
partialDate
C0574845 (UMLS CUI [1,1])
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])
Item
Is medical condition continuing?
integer
C0012634 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Continuing?
Code List
Is medical condition continuing?
CL Item
Yes (1)
CL Item
No, specify date of last occurrence  (2)
CL Item
Unknown (3)
Date of last occurence of disease relevant to SAE
Item
If NO, specify date of last occurrence
partialDate
C0011008 (UMLS CUI [1,1])
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])
Other SAE Relevant Medical History / Risk Factors
Item
Relevant Medical History / Risk Factors not noted above
text
C0205394 (UMLS CUI [1,1])
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])
Item Group
Relevant diagnostic results Entry
C1519255 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
SAE relevant Lab Sequence Number
Item
Lab Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Item
Test Name
integer
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Blllrubln total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C-reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV1 (30)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic transferase (32)
CL Item
Glutamic-pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV-DNA decreased (35)
CL Item
HBV-DNA Increased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Monocytes (51)
CL Item
Neutrophils (52)
CL Item
Oxygen saturation (53)
CL Item
pC02 (54)
CL Item
pH (55)
CL Item
Phosphate (56)
CL Item
Platelet count (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin I (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
SAE relevant Laboratory Test Date
Item
Test Date
partialDate
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2826641 (UMLS CUI [1,3])
SAE relevant Laboratory Test Result
Item
Test Result
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
SAE relevant Laboratory Test Units
Item
Test Units
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0587081 (UMLS CUI [1,4])
SAE relevant Laboratory Test Normal Low Range
Item
Normal Low Range
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2826705 (UMLS CUI [1,3])
C1518030 (UMLS CUI [1,4])
SAE relevant Laboratory Test Normal High Range
Item
Normal High Range
text
C1519255 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2826705 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
Other diagnostic test results relevant to SAE
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Item Group
Rechallenge
C2347900 (UMLS CUI-1)
Item
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C0034897 (UMLS CUI [1,1])
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])
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Code List
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Study Drug
text
C0304229 (UMLS CUI [1])
Study Drug
Code List
Study Drug
CL Item
Lapatinib (1)
Start Date
Item
Study Drug Start Date
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Study Drug Stop Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Therapeutic regimen of experimental drug
Item
Regimen
text
C1276413 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
General narrative comments
C0947611 (UMLS CUI-1)
General narrative comments
Item
General narrative comments
text
C0947611 (UMLS CUI [1])
Item Group
Non Clinical
C1298908 (UMLS CUI-2)
C0205210 (UMLS CUI-1)
Item
Send incomplete SAE data to GSK Safety
integer
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Send incomplete SAE data to GSK Safety
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (3)
SAE data: Receipt by GSK date
Item
Receipt by GSK date
partialDatetime
C2985846 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
Item
Was the event serious?
text
C1710056 (UMLS CUI [1])
Was the event serious?
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
SAE Sequence number
Item
SAE Sequence number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number of SAE Data
Item
Version Number
text
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1,1])
C3887242 (UMLS CUI [1,2])
SAE Data Email Flag
Item
Email Flag
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial