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Comparison · NCT01466348-sae

Paracetamol/Caffeine Tablet vs Paracetamol Powder: 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. Paracetamol/Caffeine Tablet vs Paracetamol Powder: serious adverse events. Trial comparisons, record NCT01466348-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01466348-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 1000.0513wilson
Risk in group 2000.0513wilson
Risk difference, group 1 minus group 20-0.05130.0513newcombe 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 1Paracetamol/Caffeine TabletParticipants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.071EG000
Group 2Paracetamol PowderParticipants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.071EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Effects of a Common Cold Treatment on Cognitive Function
NCT number
NCT01466348
Phases
PHASE4
Conditions
Common Cold
Interventions
Paracetamol and Caffeine, Paracetamol
Lead sponsor
GlaxoSmithKline
Results first posted
2013-11-25

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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