Comparison · NCT01602510-sae
Randomized Lamotrigine 200 mg/Day vs Randomized Placebo: 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. Randomized Lamotrigine 200 mg/Day vs Randomized Placebo: serious adverse events. Trial comparisons, record NCT01602510-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01602510-sae
On this page
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 | 0.0153 | 0.0042 | 0.054 | wilson | |
| Risk in group 2 | 0.0226 | 0.0077 | 0.0642 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00729 | -0.0504 | 0.0342 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.677 | 0.115 | 3.99 | log | |
| Odds ratio, group 1 over group 2 | 0.672 | 0.11 | 4.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Randomized Lamotrigine 200 mg/Day than on Randomized Placebo | 137 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Randomized Lamotrigine 200 mg/Day | Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score \<= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks. | 2 | 131 | EG001 |
| Group 2 | Randomized Placebo | Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score \<= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks. | 3 | 133 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to Study Day 230).
Source ClinicalTrials.gov
Trial
- Title
- Lamotrigine Phase III Study in Bipolar I Disorder
- NCT number
- NCT01602510
- Phases
- PHASE3
- Conditions
- Bipolar Disorder
- Interventions
- Lamotrigine, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2017-01-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01602510?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01602510-sae