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Comparison · NCT01829295-sae

Methotrexate vs Mycophenolate Mofetil: 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. Methotrexate vs Mycophenolate Mofetil: serious adverse events. Trial comparisons, record NCT01829295-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01829295-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 10.06540.0320.129wilson
Risk in group 20.06420.03150.127wilson
Risk difference, group 1 minus group 20.0012-0.06960.0727newcombe hybrid score
Risk ratio, group 1 over group 21.020.372.81log
Odds ratio, group 1 over group 21.020.3453.01log
Number needed to harm, for one more participant with a serious adverse event on Methotrexate than on Mycophenolate Mofetil833from 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 1Methotrexate
oral methotrexate~Patients randomized to receive oral methotrexate in Phase I, 0-6 Months.~Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.
7107EG000
Group 2Mycophenolate Mofetil
oral mycophenolate mofetil~Patients randomized to receive oral mycophenolate mofetil in Phase I, 0-6 Months.~Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.~Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.
7109EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse event data were collected through the primary endpoint (the first 6 months) for each enrolled patient; Phase I, 0-6 Months.

Source ClinicalTrials.gov

Trial

Title
Methotrexate and Mycophenolate Mofetil for UVEITIS
NCT number
NCT01829295
Phases
PHASE3
Conditions
Uveitis
Interventions
Mycophenolate mofetil, Methotrexate, Prednisone
Lead sponsor
University of California, San Francisco
Results first posted
2019-04-26

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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