Comparison · NCT01039376-c954489f
Ofatumumab vs Observation: Number of Participants With Improvement in Response From Baseline
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Ofatumumab vs Observation: Number of Participants With Improvement in Response From Baseline. Trial comparisons, record NCT01039376-c954489f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01039376-c954489f
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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 | 0.0829 | 0.0517 | 0.13 | wilson | |
| Risk in group 2 | 0.0417 | 0.0213 | 0.0801 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0412 | -0.00825 | 0.0929 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.99 | 0.872 | 4.54 | log | |
| Odds ratio, group 1 over group 2 | 2.08 | 0.868 | 4.98 | log | |
| Number needed to treat, for one more participant with the outcome on Ofatumumab than on Observation | 24.3 | 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 | Ofatumumab | Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose. | 16 | 193 | OG000 |
| Group 2 | Observation | Participants with relapsed CLL received no treatment and were under observation for up to 2 years. | 8 | 192 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Improvement in Response From Baseline
- Description
- Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.
- Time frame
- From Baseline until the end of the study (up to 88 months)
- Population
- ITT Population. Only participants who had PR at study entry were analyzed.
Source ClinicalTrials.gov
Trial
- Title
- Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
- NCT number
- NCT01039376
- Phases
- PHASE3
- Conditions
- Leukaemia, Lymphocytic, Chronic
- Interventions
- Ofatumumab, Observation
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2015-04-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01039376?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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