Comparison · NCT00784134-sae
Alteplase vs Saline 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. Alteplase vs Saline Placebo: serious adverse events. Trial comparisons, record NCT00784134-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00784134-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 | 0.458 | 0.397 | 0.52 | wilson | |
| Risk in group 2 | 0.602 | 0.54 | 0.66 | wilson | |
| Risk difference, group 1 minus group 2 | -0.144 | -0.228 | -0.0563 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.761 | 0.643 | 0.901 | log | |
| Odds ratio, group 1 over group 2 | 0.559 | 0.392 | 0.798 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Alteplase than on Saline Placebo | 6.96 | 4.38 | 17.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Alteplase | Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 114 | 249 | EG000 |
| Group 2 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 151 | 251 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 180 days since symptom onset
Source ClinicalTrials.gov
Trial
- Title
- Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
- NCT number
- NCT00784134
- Phases
- PHASE3
- Conditions
- Intraventricular Hemorrhage
- Interventions
- Alteplase, Normal saline
- Lead sponsor
- Johns Hopkins University
- Results first posted
- 2017-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00784134?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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