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Comparison · NCT01884675-1f10877e

Ambrisentan 5mg vs Placebo: Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal

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. Ambrisentan 5mg vs Placebo: Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal. Trial comparisons, record NCT01884675-1f10877e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01884675-1f10877e

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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 1000.184wilson
Risk in group 2000.194wilson
Risk difference, group 1 minus group 20-0.1940.184newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Ambrisentan 5mgParticipants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.017OG001
Group 2PlaceboParticipants received a matching placebo tablet once daily for a period of 16 weeks.016OG000

Outcome

Type
SECONDARY
Title
Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal
Description
A significant liver chemistry result is defined as any result which met the stopping criteria defined in the study protocol. Liver events were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Number of participants who reported a significant liver chemistry result are presented.
Time frame
Weeks 4, 8, 12, and 16/Early Withdrawal
Population
ITT Population

Source ClinicalTrials.gov

Trial

Title
Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.
NCT number
NCT01884675
Phases
PHASE3
Conditions
Hypertension
Interventions
Ambrisentan 5 mg, Placebo
Lead sponsor
GlaxoSmithKline
Results first posted
2015-12-16

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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