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Comparison · NCT03939637-sae

Experimental: Eltrombopag vs Comparator: Standard Therapy: 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: Eltrombopag vs Comparator: Standard Therapy: serious adverse events. Trial comparisons, record NCT03939637-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03939637-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 10.07690.03570.158wilson
Risk in group 20.07690.02650.203wilson
Risk difference, group 1 minus group 20-0.1330.0953newcombe hybrid score
Risk ratio, group 1 over group 210.2643.79log
Odds ratio, group 1 over group 210.2364.23log
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Experimental: Eltrombopag
Patients ages 1 to \<18 years with newly diagnosed primary ITP, platelets \<30 x 10\^9/L, requiring pharmacological treatment, but without severe bleeding or need for rapid rise in counts, randomized to receive the experimental therapy (eltrombopag).
678EG000
Group 2Comparator: Standard Therapy
Patients ages 1 to \<18 years with newly diagnosed primary ITP, platelets \<30 x 10\^9/L, requiring pharmacological treatment, but without severe bleeding or need for rapid rise in counts, randomized to receive standard therapy (investigator choice of glucocorticoids, IVIg, anti-D immunoglobulin).
339EG001

Harm

What it counts
Total, serious adverse events
Time frame
12 weeks (during which data was collected, and is now reported, in reference to the primary endpoint and/or primary outcome of the study -- proportion of patients achieving a durable platelet response of at least 3 of 4 platelet counts over 50 x10^9/L without rescue therapy during weeks 6-12 of study)

Source ClinicalTrials.gov

Trial

Title
Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children
NCT number
NCT03939637
Phases
PHASE3
Conditions
Immune Thrombocytopenia
Interventions
Eltrombopag, Steroids, IVIG, Rho(D) Immune Globulin
Lead sponsor
Baylor College of Medicine
Results first posted
2025-07-29

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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