Comparison · NCT01259388-sae
Lithium 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
Cite this record
ConductScience Library. Lithium vs Observation: serious adverse events. Trial comparisons, record NCT01259388-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01259388-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 | 0.0435 | 0.00772 | 0.21 | wilson | |
| Risk in group 2 | 0.0556 | 0.00988 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0121 | -0.217 | 0.161 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.783 | 0.0525 | 11.7 | log | |
| Odds ratio, group 1 over group 2 | 0.773 | 0.045 | 13.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lithium than on Observation | 82.8 | 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 | Lithium | Lithium-treatment phase~Lithium Carbonate: Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time. | 1 | 23 | EG000 |
| Group 2 | Observation | During observation subjects continued on their standard of care disease modifying agent (or no agent at all if judged not appropriate by the treating physician). | 1 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected over the entire period of study involvement (2 years). For each subject, 1 year was observation and the other year subjects were taking the study medication, lithium carbonate.
Source ClinicalTrials.gov
Trial
- Title
- A Pilot Study of Lithium in Progressive Multiple Sclerosis
- NCT number
- NCT01259388
- Phases
- PHASE1, PHASE2
- Conditions
- Multiple Sclerosis
- Interventions
- Lithium Carbonate
- Lead sponsor
- VA Office of Research and Development
- Results first posted
- 2019-09-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01259388?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.
For software
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