Darapladib vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.426 | 0.415 | 0.437 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.437 | 0.426 | 0.448 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0112 | -0.0266 | 0.00424 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.974 | 0.94 | 1.01 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.955 | 0.897 | 1.02 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on Darapladib than on Placebo | 89.3 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Darapladib | Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily. | 3,369 | 7,912 | EG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants were randomized to receive matching placebo once daily. | 3,448 | 7,890 | EG000 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Start=Randomization; Stop=Longer of 35 days after last dose of IP or follow-up (FU) visit. SAEs assessed as related to IP, study participation, or a GSK concomitant medication and cancer/GI polyps/neoplasms were recorded up to/including any FU contact. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial | ClinicalTrials.gov |
| NCT number | NCT00799903 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Atherosclerosis | ClinicalTrials.gov |
| Interventions | Darapladib, Placebo | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2017-08-10 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00799903?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.