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Comparison · NCT03614728-sae

Part 1: GSK3326595 400 mg vs Part 1: GSK3326595 300 mg: 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. Part 1: GSK3326595 400 mg vs Part 1: GSK3326595 300 mg: serious adverse events. Trial comparisons, record NCT03614728-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03614728-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 10.8460.5780.957wilson
Risk in group 20.7060.4690.867wilson
Risk difference, group 1 minus group 20.14-0.1730.402newcombe hybrid score
Risk ratio, group 1 over group 21.20.8161.76log
Odds ratio, group 1 over group 22.290.36714.3log
Number needed to harm, for one more participant with a serious adverse event on Part 1: GSK3326595 400 mg than on Part 1: GSK3326595 300 mg7.13from 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 1Part 1: GSK3326595 400 mgParticipants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.1113EG000
Group 2Part 1: GSK3326595 300 mgParticipants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.1217EG001

Harm

What it counts
Total, serious adverse events
Time frame
All-cause mortality, common non-STEAEs and STEAEs were collected up to 30.8 months in Part 1 of the study

Source ClinicalTrials.gov

Trial

Title
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
NCT number
NCT03614728
Phases
PHASE1, PHASE2
Conditions
Neoplasms
Interventions
GSK3326595, 5-Azacitidine
Lead sponsor
GlaxoSmithKline
Results first posted
2023-02-06

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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