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Comparison · NCT03897036-sae

Treatment-Duration-Increment vs Expansion: 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. Treatment-Duration-Increment vs Expansion: serious adverse events. Trial comparisons, record NCT03897036-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03897036-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 10.250.07150.591wilson
Risk in group 20.1760.06190.41wilson
Risk difference, group 1 minus group 20.0735-0.2210.433newcombe hybrid score
Risk ratio, group 1 over group 21.420.2926.87log
Odds ratio, group 1 over group 21.560.20511.8log
Number needed to harm, for one more participant with a serious adverse event on Treatment-Duration-Increment than on Expansion13.6from 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 1Treatment-Duration-Increment1000 mg BID × 28 days/cycle~CX-4945: API powder-in-capsule in 200 mg strength28EG000
Group 2Expansion1000 mg BID × 28 days/cycle~CX-4945: API powder-in-capsule in 200 mg strength317EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse events data were collected After informed consent, but prior to initiation of study drug, only SAEs caused by a protocol-mandated intervention will be collected (e.g., SAEs related to invasive procedures such as biopsies, medication washout, or no treatment run-in). After initiation of study drug, all AEs and SAEs regardless of attribution will be collected until 30 days following the last administration of study treatment or study discontinuation/termination, whichever is later.

Source ClinicalTrials.gov

Trial

Title
Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)
NCT number
NCT03897036
Phases
PHASE1
Conditions
Carcinoma, Basal Cell
Interventions
CX-4945
Lead sponsor
Senhwa Biosciences, Inc.
Results first posted
2025-05-20

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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