Comparison · NCT00711646-dc3e8f04
Sativex vs Placebo: Incidence of Adverse Events as a Measure of Subject Safety
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: Incidence of Adverse Events as a Measure of Subject Safety. Trial comparisons, record NCT00711646-dc3e8f04. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00711646-dc3e8f04
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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 | 0.823 | 0.746 | 0.88 | wilson | |
| Risk in group 2 | 0.708 | 0.588 | 0.804 | wilson | |
| Risk difference, group 1 minus group 2 | 0.115 | -0.00831 | 0.248 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.974 | 1.39 | log | |
| Odds ratio, group 1 over group 2 | 1.92 | 0.946 | 3.88 | log | |
| Number needed to treat, for one more participant with the outcome on Sativex than on Placebo | 8.7 | 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. | 102 | 124 | OG000 |
| Group 2 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. | 46 | 65 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Incidence of Adverse Events as a Measure of Subject Safety
- Description
- The number of subjects who reported an adverse event during the course of the study is presented.
- Time frame
- Day 0-52
- Population
- All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
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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