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Comparison · NCT00931723-sae

Lithium+Quetiapine XR vs Placebo+Quetiapine XR: 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. Lithium+Quetiapine XR vs Placebo+Quetiapine XR: serious adverse events. Trial comparisons, record NCT00931723-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00931723-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 10.02310.009030.0579wilson
Risk in group 20.04370.02230.0839wilson
Risk difference, group 1 minus group 2-0.0206-0.06320.0203newcombe hybrid score
Risk ratio, group 1 over group 20.5290.1621.72log
Odds ratio, group 1 over group 20.5180.1531.75log
Number needed to treat, for one fewer participant with a serious adverse event on Lithium+Quetiapine XR than on Placebo+Quetiapine XR48.6from 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 1Lithium+Quetiapine XRLithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day4173EG000
Group 2Placebo+Quetiapine XRPlacebo+quetiapine XR 400 to 800 mg/day8183EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Adult Bipolar Mania
NCT number
NCT00931723
Phases
PHASE4
Conditions
Acute Mania
Interventions
Quetiapine fumarate XR, Lithium, Placebo
Lead sponsor
AstraZeneca
Results first posted
2012-04-19

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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