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Comparison · NCT00672490-sae

Quetiapine Fumarate Used as Mono-Therapy vs Quetiapine Fumarate Used as Adjunct Therapy: 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. Quetiapine Fumarate Used as Mono-Therapy vs Quetiapine Fumarate Used as Adjunct Therapy: serious adverse events. Trial comparisons, record NCT00672490-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00672490-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 1000.0201wilson
Risk in group 20.005290.0009350.0294wilson
Risk difference, group 1 minus group 2-0.00529-0.02940.0153newcombe 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 Quetiapine Fumarate Used as Mono-Therapy than on Quetiapine Fumarate Used as Adjunct Therapy189from 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 1Quetiapine Fumarate Used as Mono-TherapyQuetiapine Fumarate 600 to 800 mg/day0187EG000
Group 2Quetiapine Fumarate Used as Adjunct TherapyQuetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day1189EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder
NCT number
NCT00672490
Phases
PHASE4
Conditions
Acute Mania in Bipolar Disorder
Interventions
Quetiapine Fumarate, Lithium
Lead sponsor
AstraZeneca
Results first posted
2012-07-12

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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