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Comparison · NCT01732913-sae

Idelalisib + Rituximab vs Placebo + Rituximab: 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. Idelalisib + Rituximab vs Placebo + Rituximab: serious adverse events. Trial comparisons, record NCT01732913-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01732913-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 10.520.4510.589wilson
Risk in group 20.1160.06590.196wilson
Risk difference, group 1 minus group 20.4040.2990.489newcombe hybrid score
Risk ratio, group 1 over group 24.492.547.96log
Odds ratio, group 1 over group 28.284.1616.5log
Number needed to harm, for one more participant with a serious adverse event on Idelalisib + Rituximab than on Placebo + Rituximab2.472.043.35from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Idelalisib + RituximabIdelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions103198EG000
Group 2Placebo + RituximabPlacebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions1195EG001

Harm

What it counts
Total, serious adverse events
Time frame
Up to 27 months plus 30 days

Source ClinicalTrials.gov

Trial

Title
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
NCT number
NCT01732913
Phases
PHASE3
Conditions
Indolent Non-Hodgkin's Lymphomas
Interventions
Placebo, Rituximab, Idelalisib
Lead sponsor
Gilead Sciences
Results first posted
2017-05-11

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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