Intensive Control of SBP vs Standard Control of SBP: 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 | 0.383 | 0.369 | 0.397 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.371 | 0.357 | 0.385 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0126 | -0.00705 | 0.0322 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.981 | 1.09 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.97 | 1.15 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Intensive Control of SBP than on Standard Control of SBP | 79.5 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Intensive Control of SBP | Participants randomized into the Intensive BP arm had a goal of SBP \<120 mm Hg. 2-drug therapy initiated in most participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP \<120 mm Hg; at periodic visits: addition of another drug required if not at goal.~Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both groups to achieve study goals:~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics | 1,793 | 4,678 | EG000 | ClinicalTrials.gov |
| Group 2 | Standard Control of SBP | Participants randomized into the Standard arm had a goal of SBP \<140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP \<130 mm Hg @ 1 visit; \<135 mm Hg @ 2 consecutive visits~Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm. | 1,736 | 4,683 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Includes Serious Adverse Events (SAEs) reported after randomization and throughout the duration of the trial, mean follow-up was 3.26 years. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Systolic Blood Pressure Intervention Trial | ClinicalTrials.gov |
| NCT number | NCT01206062 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Hypertension | ClinicalTrials.gov |
| Interventions | Intensive control of SBP, Standard control of SBP | ClinicalTrials.gov |
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) | ClinicalTrials.gov |
| Results first posted | 2017-12-04 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01206062?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.