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Comparison · NCT05011513-sae

Nirmatrelvir 300 mg + Ritonavir 100 mg vs 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. Nirmatrelvir 300 mg + Ritonavir 100 mg vs Placebo: serious adverse events. Trial comparisons, record NCT05011513-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05011513-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.01220.006210.024wilson
Risk in group 20.02050.0120.0348wilson
Risk difference, group 1 minus group 2-0.00827-0.02380.00619newcombe hybrid score
Risk ratio, group 1 over group 20.5970.2491.43log
Odds ratio, group 1 over group 20.5920.2441.44log
Number needed to treat, for one fewer participant with a serious adverse event on Nirmatrelvir 300 mg + Ritonavir 100 mg than on Placebo121from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Nirmatrelvir 300 mg + Ritonavir 100 mgParticipants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5.8654EG000
Group 2PlaceboParticipants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 doses from Day 1 through Day 5.13634EG001

Harm

What it counts
Total, serious adverse events
Time frame
SAEs and Non-SAEs: From Day 1 to Week 24; All-cause mortality: till Week 24

Source ClinicalTrials.gov

Trial

Title
Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
NCT number
NCT05011513
Phases
PHASE2, PHASE3
Conditions
COVID-19
Interventions
PF-07321332, Ritonavir, Placebo, Placebo
Lead sponsor
Pfizer
Results first posted
2023-08-14

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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