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Comparison · NCT02792231-sae

OMB 20mg vs TER 14mg: serious adverse events

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. OMB 20mg vs TER 14mg: serious adverse events. Trial comparisons, record NCT02792231-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02792231-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.08730.06520.116wilson
Risk in group 20.07810.05720.106wilson
Risk difference, group 1 minus group 20.00926-0.02610.0447newcombe hybrid score
Risk ratio, group 1 over group 21.120.7331.71log
Odds ratio, group 1 over group 21.130.7121.79log
Number needed to harm, for one more participant with a serious adverse event on OMB 20mg than on TER 14mg108from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1OMB 20mgOfatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter (+ teriflunomide-matching placebo capsule orally once daily)42481EG000
Group 2TER 14mgTeriflunomide 14 mg capsule orally once daily (+ ofatumumab-matching placebo injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter)37474EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 2.7 years

Source ClinicalTrials.gov

Trial

Title
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
NCT number
NCT02792231
Phases
PHASE3
Conditions
Relapsing Multiple Scelrosis
Interventions
Ofatumumab subcutaneous injection, Teriflunomide-matching placebo capsules, Teriflunomide capsule, Matching placebo of ofatumumab subcutaneous injections
Lead sponsor
Novartis Pharmaceuticals
Results first posted
2020-10-19

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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