Aspirin vs Placebo Aspirin: Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only)

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	Source
Risk in group 1	0.0406	0.0364	0.0452	wilson	ClinicalTrials.gov
Risk in group 2	0.0317	0.028	0.0358	wilson	ClinicalTrials.gov
Risk difference, group 1 minus group 2	0.00891	0.00304	0.0148	newcombe hybrid score	ClinicalTrials.gov
Risk ratio, group 1 over group 2	1.28	1.09	1.51	log	ClinicalTrials.gov
Odds ratio, group 1 over group 2	1.29	1.09	1.53	log	ClinicalTrials.gov
Number needed to treat, for one more participant with the outcome on Aspirin than on Placebo Aspirin	112	67.5	329	from the risk difference interval	ClinicalTrials.gov

Groups 2

Group 2 names the comparator: placebo.

Group	Title	Description	With the outcome	Analysed	ClinicalTrials.gov code	Source
Group 1	Aspirin	Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm	314	7,740	OG000	ClinicalTrials.gov
Group 2	Placebo Aspirin	Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm	245	7,740	OG001	ClinicalTrials.gov

Outcome 5

Field	Value	Source
Type	PRIMARY	ClinicalTrials.gov
Title	Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only)	ClinicalTrials.gov
Description	The primary safety assessments involve intention-to-treat comparisons among all randomized patients of allocation to aspirin versus placebo on the first occurrence of any major bleed, defined as:~* any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or~* sight-threatening eye bleeding; or~* any other serious bleeding episode.	ClinicalTrials.gov
Time frame	Randomized treatment phase during a mean of 7.4 years	ClinicalTrials.gov
Population		ClinicalTrials.gov

Trial 8

Field	Value	Source
Title	ASCEND: A Study of Cardiovascular Events iN Diabetes	ClinicalTrials.gov
NCT number	NCT00135226	ClinicalTrials.gov
Phases	PHASE4	ClinicalTrials.gov
Conditions	Diabetes Mellitus	ClinicalTrials.gov
Interventions	Aspirin, Omega-3 Ethyl Esters, Placebo Aspirin, Placebo Omega-3 Ethyl Esters	ClinicalTrials.gov
Lead sponsor	University of Oxford	ClinicalTrials.gov
Results first posted	2019-04-26	ClinicalTrials.gov
Results on ClinicalTrials.gov	https://clinicaltrials.gov/study/NCT00135226?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

The same record as JSON

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.