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Comparison · NCT03192995-sae

Experimental vs Control: 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. Experimental vs Control: serious adverse events. Trial comparisons, record NCT03192995-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03192995-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 10.06250.01110.283wilson
Risk in group 20.1670.03010.564wilson
Risk difference, group 1 minus group 2-0.104-0.5040.155newcombe hybrid score
Risk ratio, group 1 over group 20.3750.02765.09log
Odds ratio, group 1 over group 20.3330.01746.37log
Number needed to treat, for one fewer participant with a serious adverse event on Experimental than on Control9.6from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Experimentallorcaserin, extended release~lorcaserin: lorcaserin 20 mg tablet116EG000
Group 2ControlPlacebo~Placebo Oral Tablet: placebo 20 mg. tablet16EG001

Harm

What it counts
Total, serious adverse events
Time frame
After baseline, Adverse event data were collected weekly over the 12 week period of the study.

Source ClinicalTrials.gov

Trial

Title
Treatment With Lorcaserin for Cocaine Use: The TLC Study
NCT number
NCT03192995
Phases
PHASE2
Conditions
Cocaine Use Disorder
Interventions
lorcaserin, Placebo Oral Tablet, Substance use counseling, ACASI, Cocaine metabolites, Ecological Momentary Assessment (EMA), Balloon Analogue Risk Task (BART), Qualitative Exit Interview
Lead sponsor
Glenn-Milo Santos
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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