Comparison · NCT03933202-sae
Cladribine Tablets: Switch From Oral vs Cladribine Tablets: Switch From Infusion: serious adverse events
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. Cladribine Tablets: Switch From Oral vs Cladribine Tablets: Switch From Infusion: serious adverse events. Trial comparisons, record NCT03933202-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03933202-sae
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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 | 0.0971 | 0.0536 | 0.17 | wilson | |
| Risk in group 2 | 0.165 | 0.101 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0676 | -0.17 | 0.0291 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.589 | 0.276 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 0.545 | 0.229 | 1.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cladribine Tablets: Switch From Oral than on Cladribine Tablets: Switch From Infusion | 14.8 | 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 | Cladribine Tablets: Switch From Oral | Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. | 10 | 103 | EG000 |
| Group 2 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. | 14 | 85 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline (Month 0) up to 24 months
Source ClinicalTrials.gov
Trial
- Title
- A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
- NCT number
- NCT03933202
- Phases
- Conditions
- Multiple Sclerosis
- Interventions
- Cladribine Tablets
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Results first posted
- 2026-01-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03933202?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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