Comparison · NCT00811733-2cda7433
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 vs 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5: Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 vs 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5: Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator. Trial comparisons, record NCT00811733-2cda7433. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00811733-2cda7433
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.333 | 0.152 | 0.583 | wilson | |
| Risk in group 2 | 0.636 | 0.43 | 0.803 | wilson | |
| Risk difference, group 1 minus group 2 | -0.303 | -0.549 | 0.0211 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.524 | 0.24 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.286 | 0.0718 | 1.14 | log | |
| Number needed to treat, for one fewer participant with the outcome on 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 than on 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 3.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5. | 5 | 15 | OG000 |
| Group 2 | 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5. | 14 | 22 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator
- Description
OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.
- Time frame
- Baseline and up to Study Week 16
- Population
- ITT Population
Source ClinicalTrials.gov
Trial
- Title
- A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
- NCT number
- NCT00811733
- Phases
- PHASE2
- Conditions
- Waldenstrom Macroglobulinaemia
- Interventions
- Ofatumumab
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-04-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00811733?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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