Comparison · NCT00883493-sae
Quetiapine XR vs Quatiapine XR + Lithium: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Quetiapine XR vs Quatiapine XR + Lithium: serious adverse events. Trial comparisons, record NCT00883493-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00883493-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0236 | 0.0101 | 0.054 | wilson | |
| Risk in group 2 | 0.0239 | 0.0103 | 0.0548 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000339 | -0.034 | 0.033 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.986 | 0.29 | 3.36 | log | |
| Odds ratio, group 1 over group 2 | 0.986 | 0.281 | 3.46 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Quetiapine XR than on Quatiapine XR + Lithium | 2,950 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Quetiapine XR | Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. | 5 | 212 | EG000 |
| Group 2 | Quatiapine XR + Lithium | Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day. | 5 | 209 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
- NCT number
- NCT00883493
- Phases
- PHASE3
- Conditions
- Acute Bipolar Depression
- Interventions
- Quetiapine fumarate XR, Lithium carbonate
- Lead sponsor
- AstraZeneca
- Results first posted
- 2012-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00883493?tab=results
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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