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Comparison · NCT01202279-sae

Mucinex D 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. Mucinex D vs Placebo: serious adverse events. Trial comparisons, record NCT01202279-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01202279-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 1000.00644wilson
Risk in group 200.0000000000000000004340.00646wilson
Risk difference, group 1 minus group 20-0.006460.00644newcombe 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

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Mucinex DMucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days0593EG000
Group 2PlaceboPlacebo given bid with a full glass of water for 7 days0591EG001

Harm

What it counts
Total, serious adverse events
Time frame
Upon signing of the informed consent, the patient was requested to report all AEs experienced throughout the duration of their participation in this study. AEs were followed until resolution, stability or until 30 days after last dose of study medication.

Source ClinicalTrials.gov

Trial

Title
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
NCT number
NCT01202279
Phases
PHASE4
Conditions
Acute Upper Respiratory Track Infection
Interventions
Guaifenesin, Placebo
Lead sponsor
Reckitt Benckiser Inc.
Results first posted
2012-11-05

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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