Alirocumab 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	Source
Risk in group 1	0.233	0.225	0.242	wilson	ClinicalTrials.gov
Risk in group 2	0.249	0.24	0.258	wilson	ClinicalTrials.gov
Risk difference, group 1 minus group 2	-0.0159	-0.0281	-0.00367	newcombe hybrid score	ClinicalTrials.gov
Risk ratio, group 1 over group 2	0.936	0.89	0.985	log	ClinicalTrials.gov
Odds ratio, group 1 over group 2	0.917	0.858	0.98	log	ClinicalTrials.gov
Number needed to treat, for one fewer participant with a serious adverse event on Alirocumab than on Placebo	63	35.6	272	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	Alirocumab	Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).	2,202	9,451	EG001	ClinicalTrials.gov
Group 2	Placebo	Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	2,350	9,443	EG000	ClinicalTrials.gov

Harm 2

Field	Value	Source
What it counts	Total, serious adverse events	ClinicalTrials.gov
Time frame	All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP).	ClinicalTrials.gov

Trial 8

Field	Value	Source
Title	ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab	ClinicalTrials.gov
NCT number	NCT01663402	ClinicalTrials.gov
Phases	PHASE3	ClinicalTrials.gov
Conditions	Atherosclerotic Cardiovascular Disease	ClinicalTrials.gov
Interventions	Alirocumab, Placebo, LMT	ClinicalTrials.gov
Lead sponsor	Sanofi	ClinicalTrials.gov
Results first posted	2019-03-18	ClinicalTrials.gov
Results on ClinicalTrials.gov	https://clinicaltrials.gov/study/NCT01663402?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.