Comparison · NCT05306873-b0e1bf48
Stage 2 MMF vs Stage 2 Placebo for MMF: The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 2
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. Stage 2 MMF vs Stage 2 Placebo for MMF: The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 2. Trial comparisons, record NCT05306873-b0e1bf48. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05306873-b0e1bf48
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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 | 0 | 0.49 | wilson | |
| Risk in group 2 | 0 | 0 | 0.49 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.49 | 0.49 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Stage 2 MMF | Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day. | 0 | 4 | OG000 |
| Group 2 | Stage 2 Placebo for MMF | Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day. | 0 | 4 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 2
- Description
- Defined as adverse events that emerged during Stage 2 that are of Grade 3 or higher with a relationship to Stage 2 study drug of Possible or Definite.
- Time frame
- Stage 2 Day 0 up to Stage 2 Week 48
- Population
- Includes all participants who received at least one dose of Stage 2 study drug.
Source ClinicalTrials.gov
Trial
- Title
- Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
- NCT number
- NCT05306873
- Phases
- PHASE2
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Mycophenolate Mofetil, Placebo for Mycophenolate Mofetil, Voclosporin, Placebo for Voclosporin, Mycophenolate Mofetil
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2025-09-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05306873?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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