ID
42512
Beschreibung
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
Stichworte
Versionen (1)
- 10.08.21 10.08.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
10. August 2021
DOI
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Lizenz
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Non-serious Adverse event
- StudyEvent: ODM
Beschreibung
Non-serious adverse event
Alias
- UMLS CUI-1
- C1518404
Beschreibung
[hidden] Item is not required
Datentyp
text
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Diagnosis only (if known) Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
[hidden] Item is not required
Datentyp
text
Alias
- UMLS CUI [1]
- C2826798
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Non-serious adverse event, start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1518404
Beschreibung
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beschreibung
AE end time is required for all events starting on ofatumumab treatment days
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0806020
Beschreibung
Non-serious adverse event, recoverd/resolved, End date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0806020
Beschreibung
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C1522314
Beschreibung
Non-serious adverse event, recoverd/resolved with sequelae, End date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0243088
- UMLS CUI [1,4]
- C0806020
Beschreibung
AE end time is required for all events starting on ofatumumab treatment days. For all other AEs end Time is optional.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1709863
- UMLS CUI [1,3]
- C0243088
- UMLS CUI [1,4]
- C1522314
Beschreibung
[hidden] Item is not required This item is optional
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0518690
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0574845
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0332162
Beschreibung
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.
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]
- C0806909
- UMLS CUI [2,3]
- C0518690
Beschreibung
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
Datentyp
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
Beschreibung
Action Taken with Investigational Product as Result of the AE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschreibung
Item is not required
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0422727
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
boolean
Alias
- UMLS CUI [1,1]
- C0332149
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C1518404
Beschreibung
[hidden] Item is not required If AE start and end time are used this item must be hidden.
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beschreibung
[hidden] Item is not required
Datentyp
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
Ähnliche Modelle
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])