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Comparison · NCT03002038-87ea9c77

Azathioprine vs Rituximab: Number of Participants With Adverse Drug Reactions

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. Azathioprine vs Rituximab: Number of Participants With Adverse Drug Reactions. Trial comparisons, record NCT03002038-87ea9c77. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03002038-87ea9c77

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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 10.06520.02240.175wilson
Risk in group 20.10.03960.231wilson
Risk difference, group 1 minus group 2-0.0348-0.1720.0906newcombe hybrid score
Risk ratio, group 1 over group 20.6520.1552.74log
Odds ratio, group 1 over group 20.6280.1322.99log
Number needed to treat, for one fewer participant with the outcome on Azathioprine than on Rituximab28.7from 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 1Azathioprine
Patients in this group will receive 50 mg of azathioprine, two times each day and gradually increased to maximum dose of 3 g daily with the aim of lymphocytes count less than 1500.~Azathioprine: Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose.
346OG000
Group 2Rituximab
Patients in this group will receive 1g of Rituximab in 500 cc normal saline serum through intravenous infusion with two weeks intervals (as one course) and each course of treatment is repeated every 6 months.~Rituximab: Patients will receive 1 g of Rituximab (two vials of RediTux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion and this will be repeated two weeks later. This cycle will be repeated every 6 months.
440OG001

Outcome

Type
OTHER_PRE_SPECIFIED
Title
Number of Participants With Adverse Drug Reactions
Description
adverse drug reactions will be observed closely and reported during the intervention. We will compare the number of adverse drug reactions in two groups. Also, adverse drug reactions will be described by details in each group.
Time frame
one year
Population
intention to treat analysis

Source ClinicalTrials.gov

Trial

Title
Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
NCT number
NCT03002038
Phases
PHASE2, PHASE3
Conditions
Neuromyelitis Optica Spectrum Disorder
Interventions
Azathioprine, Rituximab
Lead sponsor
Isfahan University of Medical Sciences
Results first posted
2020-09-30

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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