ID
42512
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00811733
Nyckelord
Versioner (1)
- 2021-08-10 2021-08-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
10 augusti 2021
DOI
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Licens
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Non-serious Adverse event
- StudyEvent: ODM
Beskrivning
Non-serious adverse event
Alias
- UMLS CUI-1
- C1518404
Beskrivning
[hidden] Item is not required
Datatyp
text
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Diagnosis only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
[hidden] Item is not required
Datatyp
text
Alias
- UMLS CUI [1]
- C2826798
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Non-serious adverse event, start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1518404
Beskrivning
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beskrivning
AE end time is required for all events starting on ofatumumab treatment days
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0806020
Beskrivning
Non-serious adverse event, recoverd/resolved, End date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0806020
Beskrivning
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional.
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C1522314
Beskrivning
Non-serious adverse event, recoverd/resolved with sequelae, End date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0243088
- UMLS CUI [1,4]
- C0806020
Beskrivning
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional.
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0243088
- UMLS CUI [1,4]
- C1522314
Beskrivning
[hidden] Item is not required This item is optional
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0518690
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0574845
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0332162
Beskrivning
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.
Datatyp
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
Beskrivning
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
Datatyp
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
Beskrivning
Action Taken with Investigational Product as Result of the AE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beskrivning
Item is not required
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0422727
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332149
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C1518404
Beskrivning
[hidden] Item is not required If AE start and end time are used this item must be hidden.
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beskrivning
[hidden] Item is not required
Datatyp
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
Similar models
Non-serious Adverse event
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C1709863 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1709863 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C1709863 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,4])
C0439603 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0441800 (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])
C1518404 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,3])
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])
C1518404 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0422727 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,2])
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])