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Comparison · NCT00049673-sae

Prednisone vs Observation: 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. Prednisone vs Observation: serious adverse events. Trial comparisons, record NCT00049673-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00049673-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 10.03030.0130.069wilson
Risk in group 20.01230.003370.0436wilson
Risk difference, group 1 minus group 20.018-0.01780.0577newcombe hybrid score
Risk ratio, group 1 over group 22.470.48612.5log
Odds ratio, group 1 over group 22.520.48113.2log
Number needed to harm, for one more participant with a serious adverse event on Prednisone than on Observation55.5from 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 1Prednisone
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.~prednisone: Given orally~thalidomide: Given orally
5165EG000
Group 2ObservationPatients undergo observation.2163EG001

Harm

What it counts
Total, serious adverse events
Time frame
9 years

Source ClinicalTrials.gov

Trial

Title
Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
NCT number
NCT00049673
Phases
PHASE3
Conditions
Multiple Myeloma and Plasma Cell Neoplasm
Interventions
prednisone, thalidomide
Lead sponsor
NCIC Clinical Trials Group
Results first posted
2020-10-05

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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