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Comparison · NCT02296346-sae

Corticosteriod Arm vs Extracorporeal Photopheresis: 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. Corticosteriod Arm vs Extracorporeal Photopheresis: serious adverse events. Trial comparisons, record NCT02296346-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02296346-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 100.00000000000000005550.354wilson
Risk in group 20.1670.03010.564wilson
Risk difference, group 1 minus group 2-0.167-0.5640.213newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer participant with a serious adverse event on Corticosteriod Arm than on Extracorporeal Photopheresis6from 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 1Corticosteriod ArmPatients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.~SoluMedrol: Infusion of drug subcutaneously, once a month.07EG000
Group 2Extracorporeal Photopheresis
Patient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows:~ECP will be administered according to the following schedule:~Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks~Extracorporeal Photopheresis: This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body.
16EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse event data were collected on study participants from baseline visit to study completion, approximately 2 years.

Source ClinicalTrials.gov

Trial

Title
Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis
NCT number
NCT02296346
Phases
NA
Conditions
Secondary Progressive Multiple Sclerosis
Interventions
SoluMedrol, Extracorporeal Photopheresis
Lead sponsor
University of Utah
Results first posted
2019-08-14

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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