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Comparison · NCT02168855-sae

Active Nicotine Gum vs Inactive Gum: 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. Active Nicotine Gum vs Inactive Gum: serious adverse events. Trial comparisons, record NCT02168855-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02168855-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 10.04970.02640.0918wilson
Risk in group 20.07450.04490.121wilson
Risk difference, group 1 minus group 2-0.0247-0.07690.0267newcombe hybrid score
Risk ratio, group 1 over group 20.6680.2961.5log
Odds ratio, group 1 over group 20.650.2741.54log
Number needed to treat, for one fewer participant with a serious adverse event on Active Nicotine Gum than on Inactive Gum40.4from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Active Nicotine Gumactive nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum~Standard behavioral therapy: Standard behavioral therapy for smoking cessation9181EG000
Group 2Inactive GumStandard behavioral therapy: Standard behavioral therapy for smoking cessation14188EG001

Harm

What it counts
Total, serious adverse events
Time frame
Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months.

Source ClinicalTrials.gov

Trial

Title
Cessation in Non-Daily Smokers
NCT number
NCT02168855
Phases
NA
Conditions
Smoking
Interventions
active nicotine gum, Standard behavioral therapy
Lead sponsor
Brian Primack
Results first posted
2020-05-06

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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