Comparison · NCT01039376-cd0f7f1e
Ofatumumab vs Observation: Number of Participants With Grade 3 and Above Adverse Event of Infection
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 Grade 3 and Above Adverse Event of Infection. Trial comparisons, record NCT01039376-cd0f7f1e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01039376-cd0f7f1e
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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 | 0.159 | 0.118 | 0.211 | wilson | |
| Risk in group 2 | 0.0954 | 0.0644 | 0.139 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0636 | 0.0037 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 1.02 | 2.71 | log | |
| Odds ratio, group 1 over group 2 | 1.79 | 1.03 | 3.11 | log | |
| Number needed to treat, for one more participant with the outcome on Ofatumumab than on Observation | 15.7 | 8.07 | 270 | from the risk difference interval |
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. | 38 | 239 | OG000 |
| Group 2 | Observation | Participants with relapsed CLL received no treatment and were under observation for up to 2 years. | 23 | 241 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Grade 3 and Above Adverse Event of Infection
- Description
Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).
- Time frame
- From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 26 months)
- Population
- Safety Population: all participants who were randomized in the study and analyses were done based on the treatment the participant received regardless of how they were randomized.
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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