ID

42512

Description

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out whenever/if a non-serious adverse event occurred during study. Use one form for each event.

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Keywords

Versions (1)
  1. 8/10/21 8/10/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 10, 2021

DOI

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License

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

English

Non-serious Adverse event

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
subject number
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
date of examination
Description

if different from date of visit

Data type

date

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C0011008
Non-serious adverse event
Description

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
Sequence number
Description

[hidden] Item is not required

Data type

text

Alias
UMLS CUI [1]
C2348184
Event
Description

Diagnosis only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C1518404
Modified term
Description

[hidden] Item is not required

Data type

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Description

[hidden]

Data type

text

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start date
Description

Non-serious adverse event, start date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start time
Description

AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Outcome / End date
Description

AE end time is required for all events starting on ofatumumab treatment days

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0806020
If recovered/resolved, provide End Date:
Description

Non-serious adverse event, recoverd/resolved, End date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0806020
If recovered/resolved, provide End time:
Description

AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional.

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C1522314
If recovered/resolved with sequelae, provide End Date:
Description

Non-serious adverse event, recoverd/resolved with sequelae, End date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0243088
UMLS CUI [1,4]
C0806020
If recovered/resolved with sequelae, provide End time:
Description

AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional.

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1709863
UMLS CUI [1,3]
C0243088
UMLS CUI [1,4]
C1522314
Frequency
Description

[hidden] Item is not required This item is optional

Data type

text

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

Record maximum intensity throughout duration of event Item is not required Optional item: This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.

Data type

text

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

Record intensity at the onset of the event [hidden] Item is not required 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.

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0574845
Maximum grade
Description

Record maximum grade throughout duration of event Item is not required This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.

Data type

text

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

Record grade at the onset of the event [hidden] Item is not required 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

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
Maximum grade or Intensity
Description

Record maximum grade throughout duration of event Item is not required This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.

Data type

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]
C0806909
UMLS CUI [2,3]
C0518690
Grade or Intensity at onset of event
Description

Record grade or intensity at the onset of the event [hidden] 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

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0332162
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0806909
UMLS CUI [2,3]
C0332162
Action Taken with Investigational Product(s) as a Result of the AE
Description

Action Taken with Investigational Product as Result of the AE

Data type

text

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

Item is not required

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0422727
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0332149
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1518404
Duration of AE if <24 hours
Description

[hidden] Item is not required If AE start and end time are used this item must be hidden.

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since last Dose
Description

[hidden] Item is not required

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C1272706
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C3174092
UMLS CUI [1,6]
C1517741
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Similar models

Non-serious Adverse event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
date of examination
Item
date of examination
date
C0582103 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Sequence number
Item
Sequence number
text
C2348184 (UMLS CUI [1])
Non-serious adverse event
Item
Event
text
C1518404 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826798 (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])
Non-serious adverse event, start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Non-serious adverse event, start time
Item
Start time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome / End date
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Non-serious adverse event, Outcome / End date
Code List
Outcome / End date
CL Item
Recovered / Resolved (1)
CL Item
Recovering / Resolving  (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered / resolved with sequelae (4)
Non-serious adverse event, recoverd/resolved, End date
Item
If recovered/resolved, provide End Date:
date
C1518404 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Non-serious adverse event, recoverd/resolved, End time
Item
If recovered/resolved, provide End time:
time
C1518404 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Non-serious adverse event, recoverd/resolved with sequelae, End date
Item
If recovered/resolved with sequelae, provide End Date:
date
C1518404 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Non-serious adverse event, recoverd/resolved with sequelae, End time
Item
If recovered/resolved with sequelae, provide End time:
time
C1518404 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious adverse event, frequency
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Non-serious adverse event, 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])
C0574845 (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
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious adverse event, 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
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
Non-serious adverse event, Maximum grade
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])
C0806909 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,3])
Non-serious adverse event, Maximum grade
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
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0332162 (UMLS CUI [2,3])
Non-serious adverse event, Maximum grade
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 as 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)
Subject withdrawal from study as result of AE
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0422727 (UMLS CUI [1,3])
Possibility that AE was caused by investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0332149 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Duration of AE
Item
Duration of AE if <24 hours
durationDatetime
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Non-serious adverse event, Time to Onset Since last Dose
Item
Time to Onset Since last Dose
durationDatetime
C1518404 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C3174092 (UMLS CUI [1,5])
C1517741 (UMLS CUI [1,6])
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