Comparison · NCT01176565-sae
Standard SBP Reduction Arm vs Intensive SBP Reduction Arm: 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. Standard SBP Reduction Arm vs Intensive SBP Reduction Arm: serious adverse events. Trial comparisons, record NCT01176565-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01176565-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 | 0.2 | 0.167 | 0.237 | wilson | |
| Risk in group 2 | 0.256 | 0.22 | 0.296 | wilson | |
| Risk difference, group 1 minus group 2 | -0.056 | -0.108 | -0.00397 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.781 | 0.621 | 0.984 | log | |
| Odds ratio, group 1 over group 2 | 0.727 | 0.54 | 0.978 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard SBP Reduction Arm than on Intensive SBP Reduction Arm | 17.9 | 9.29 | 252 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
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 |
|---|---|---|---|---|---|
| Group 1 | Standard SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range. | 100 | 500 | EG000 |
| Group 2 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. | 128 | 500 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected between randomization and the end-of-study visit. All adverse events (defined as abnormal test results, new diagnoses, worsening of conditions, or other health events of clinical significance) were collected through day 7 or hospital discharge, whichever came first. Only serious adverse events (SAEs) were collected from Day 7 (or discharge, if sooner) through final study visits at 3-months +/- 30 days. SAEs, 5-day reporting timeline.
Source ClinicalTrials.gov
Trial
- Title
- Antihypertensive Treatment of Acute Cerebral Hemorrhage-II
- NCT number
- NCT01176565
- Phases
- PHASE3
- Conditions
- Intracerebral Hemorrhage
- Interventions
- Intravenous nicardipine hydrochloride
- Lead sponsor
- University of Minnesota
- Results first posted
- 2017-04-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01176565?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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