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Comparison · NCT01520909-e0f87e54

Part 1 (Randomized Period) - Eltrombopag vs Part 1 (Randomized Period)-Placebo: Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1

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 (Randomized Period) - Eltrombopag vs Part 1 (Randomized Period)-Placebo: Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1. Trial comparisons, record NCT01520909-e0f87e54. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01520909-e0f87e54

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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 10.190.1120.304wilson
Risk in group 20.2410.1220.421wilson
Risk difference, group 1 minus group 2-0.0509-0.2470.114newcombe hybrid score
Risk ratio, group 1 over group 20.7890.3471.8log
Odds ratio, group 1 over group 20.7390.2572.13log
Number needed to treat, for one fewer participant with the outcome on Part 1 (Randomized Period) - Eltrombopag than on Part 1 (Randomized Period)-Placebo19.6from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Part 1 (Randomized Period) - Eltrombopag
In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
1263OG001
Group 2Part 1 (Randomized Period)-Placebo
In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
729OG000

Outcome

Type
SECONDARY
Title
Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1
Description
Rescue treatment is defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.
Time frame
From Baseline up to Week 12 of Part 1
Population
ITT Population

Source ClinicalTrials.gov

Trial

Title
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
NCT number
NCT01520909
Phases
PHASE3
Conditions
Idiopathic Thrombocytopenic Purpura
Interventions
Eltrombopag, Placebo
Lead sponsor
GlaxoSmithKline
Results first posted
2014-09-29

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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