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Comparison · NCT00564629-sae

Oral Acetaminophen (PO APAP) 1 g vs Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution: 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. Oral Acetaminophen (PO APAP) 1 g vs Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution: serious adverse events. Trial comparisons, record NCT00564629-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00564629-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 1000.07wilson
Risk in group 2000.0664wilson
Risk difference, group 1 minus group 20-0.06640.07newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Oral Acetaminophen (PO APAP) 1 ggroup of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment051EG000
Group 2Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solutiongroup of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment054EG001

Harm

What it counts
Total, serious adverse events
Time frame
Treatment Emergent Adverse Events(TEAEs)were reported from T0 (on or after the start of study medication) to 6 hours after study medication was administered to the subject.

Source ClinicalTrials.gov

Trial

Title
Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males
NCT number
NCT00564629
Phases
PHASE3
Conditions
Fever
Interventions
Intravenous acetaminophen plus oral placebo, Oral acetaminophen plus IV placebo, Reference standard endotoxin (RSE)
Lead sponsor
Mallinckrodt
Results first posted
2010-09-21

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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