Comparison · NCT00391079-sae
Sativex vs 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
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ConductScience Library. Sativex vs Placebo: serious adverse events. Trial comparisons, record NCT00391079-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00391079-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 | 0.018 | 0.00613 | 0.0515 | wilson | |
| Risk in group 2 | 0.0116 | 0.00319 | 0.0414 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00634 | -0.0257 | 0.0409 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.54 | 0.261 | 9.13 | log | |
| Odds ratio, group 1 over group 2 | 1.55 | 0.257 | 9.43 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sativex than on Placebo | 158 | 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 | Sativex | Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD. | 3 | 167 | EG000 |
| Group 2 | Placebo | Range of 8-12 sprays of placebo per day | 2 | 172 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events occurring from time of consent to post study follow up i.e. 15 weeks were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medications were also collected/
Source ClinicalTrials.gov
Trial
- Title
- Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
- NCT number
- NCT00391079
- Phases
- PHASE3
- Conditions
- Multiple Sclerosis
- Interventions
- Sativex, Placebo
- Lead sponsor
- GW Pharmaceuticals Ltd
- Results first posted
- 2012-07-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00391079?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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