Comparison · NCT00711646-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 NCT00711646-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00711646-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 | 0.0323 | 0.0126 | 0.08 | wilson | |
| Risk in group 2 | 0.0462 | 0.0158 | 0.127 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0139 | -0.0972 | 0.0427 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.699 | 0.161 | 3.03 | log | |
| Odds ratio, group 1 over group 2 | 0.689 | 0.149 | 3.18 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sativex than on Placebo | 72 | 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 | Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. | 4 | 124 | EG000 |
| Group 2 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. | 3 | 65 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events occurring from the time of consent to post study follow up (9 - 10 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.
- NCT number
- NCT00711646
- Phases
- PHASE3
- Conditions
- Spasticity, Multiple Sclerosis
- Interventions
- Sativex®, Placebo
- Lead sponsor
- Jazz Pharmaceuticals
- Results first posted
- 2012-09-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00711646?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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