ID

41225

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 non-serious adverse event documentation.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Stichworte

Versionen (1)
  1. 20.07.20 20.07.20 - Christian Arras
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Juli 2020

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

Englisch

NON-SERIOUS ADVERSE EVENT (AE)

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
NON-SERIOUS ADVERSE EVENT (AE)
Beschreibung

NON-SERIOUS ADVERSE EVENT (AE)

Alias
UMLS CUI-1
C1518404
Sequence number
Beschreibung

hidden/Item is not required

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Event, diagnosis only /if known
Beschreibung

Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Modified term
Beschreibung

(hidden/Item is not required)

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschreibung

(hidden/Item is not required)

Datentyp

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschreibung

(hidden/Item is not required)

Datentyp

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschreibung

(hidden/Item is not required)

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start Date and Time
Beschreibung

Condition Item: Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected. Hr:Min (00:00-23:59)

Datentyp

partialDatetime

Maßeinheiten
  • 24-hour clock
Alias
UMLS CUI [1]
C0808070
UMLS CUI [2]
C1301880
24-hour clock
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
If Recovered/Resolved, provide End Date and Time
Beschreibung

End Time is optional Hr:Min (00:00-23:59)

Datentyp

partialDatetime

Maßeinheiten
  • 24-hour clock
Alias
UMLS CUI [1,1]
C2826793
UMLS CUI [1,2]
C1709863
24-hour clock
If Recovered/Resolved with sequelae, provide End Date and Time
Beschreibung

End Time is optional Hr:Min (00:00-23:59)

Datentyp

partialDatetime

Maßeinheiten
  • 24-hour clock
Alias
UMLS CUI [1,1]
C2826793
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0243088
24-hour clock
Frequency
Beschreibung

This item is optional

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Maximum Intensity
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.

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Intensity at onset of event
Beschreibung

Record intensity at the onset of the event. 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.

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0332162
Maximum Grade
Beschreibung

Record maximum grade throughout duration of event. 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.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Grade at onset of event
Beschreibung

Record grade at the onset of the event. 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

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1518404
Maximum Grade or Intensity
Beschreibung

Record maximum grade or intensity throughout duration of event. Optional Item. This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
Grade or Intensity at onset of event
Beschreibung

Record grade or intensity at the onset of the event 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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1518404
UMLS CUI [2,1]
C0441800
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C1518404
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action Taken with Investigational Product(s) as a Result of the AE

Datentyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Use best judgment 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]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of AE if < 24 hours
Beschreibung

0 =< n <= 23 Hr(s), 0 =< n <= 59 Min(s) If AE start and end time are used this item must be hidden.

Datentyp

durationDatetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449238
Time to Onset Since Last Dose
Beschreibung

Hr(s), 0 =< n <= 59 Min(s) This Item is optional.

Datentyp

durationDatetime

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1517741
INTENSITY CHANGES Entry
Beschreibung

INTENSITY CHANGES Entry

Alias
UMLS CUI-1
C0518690
UMLS CUI-2
C0392747
UMLS CUI-3
C1518404
Start Date and Time of event segment
Beschreibung

Hr:Min (00:00-23:59) 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.

Datentyp

partialDate

Maßeinheiten
  • 24-hour clock
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0808070
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C1301880
24-hour clock
Intensity of event segment
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.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Grade of event segment
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]
C1518404
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
Grade or Intensity of event segment
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.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0449719
UMLS CUI [2,3]
C0441800
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Ähnliche Modelle

NON-SERIOUS ADVERSE EVENT (AE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
NON-SERIOUS ADVERSE EVENT (AE)
C1518404 (UMLS CUI-1)
Sequence number
Item
Sequence number
text
C2348184 (UMLS CUI [1])
Event: Diagnosis only
Item
Event, diagnosis only /if known
text
C0877248 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start Date and Time
Item
Start Date and Time
partialDatetime
C0808070 (UMLS CUI [1])
C1301880 (UMLS CUI [2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome / End Date and Time
Code List
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)
Recovered/Resolved, provide End Date and Time
Item
If Recovered/Resolved, provide End Date and Time
partialDatetime
C2826793 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
Recovered/Resolved with sequelae, provide End Date and Time
Item
If Recovered/Resolved with sequelae, provide End Date and Time
partialDatetime
C2826793 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
Item
Frequency
integer
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1518404 (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
C1518404 (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
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Grade
Code List
Maximum Grade
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
C0441800 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Maximum Grade or Intensity
Code List
Maximum Grade or Intensity
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])
C1518404 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C1518404 (UMLS CUI [2,3])
Maximum Grade or Intensity
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 the AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the 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 study as a result of this AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this AE?
Code List
Did the subject withdraw from study as a result of this 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
C1518404 (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 AE if < 24 hours
Item
Duration of AE if < 24 hours
durationDatetime
C1518404 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
durationDatetime
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Item Group
INTENSITY CHANGES Entry
C0518690 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
C1518404 (UMLS CUI-3)
Start Date and Time of event segment
Item
Start Date and Time of event segment
partialDate
C1518404 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
Item
Intensity of event segment
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of event segment
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
integer
C1518404 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (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
C1518404 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
Grade or Intensity of event segment
Code List
Grade or Intensity of event segment
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)
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