Comparison · NCT01416636-2ee8e26e
High Dose vs Low Dose: Number of Participants With Clinical Worsening
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. High Dose vs Low Dose: Number of Participants With Clinical Worsening. Trial comparisons, record NCT01416636-2ee8e26e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01416636-2ee8e26e
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.132 | 0.0655 | 0.248 | wilson | |
| Risk in group 2 | 0.231 | 0.137 | 0.361 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0987 | -0.245 | 0.0506 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.572 | 0.245 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 0.507 | 0.182 | 1.41 | log | |
| Number needed to treat, for one fewer participant with the outcome on High Dose than on Low Dose | 10.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | High Dose | Treprostinil sodium high dose | 7 | 53 | OG000 |
| Group 2 | Low Dose | Treprostinil sodium low dose | 12 | 52 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinical Worsening
- Description
Clinical worsening defined as a decrease of 6-minute walk test distance of more than 20% from baseline due to Chronic Thromboembolic Pulmonary Hypertension, decrease of New York Heart Association functional class, hospitalization with the requirement for additional Pulmonary Hypertension specific treatment and/or death due to worsening Chronic Thromboembolic Pulmonary Hypertension.~Clinical Worsening was assessed after 12 weeks and 24 weeks, participants experiencing clinical worsening at any time-point are reported.
- Time frame
- 12 weeks and 24 weeks
- Population
- All randomized subjects who received at least one dose of study medication.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
- NCT number
- NCT01416636
- Phases
- PHASE3
- Conditions
- Non-operable Chronic Thromboembolic Pulmonary Hypertension
- Interventions
- Treprostinil sodium
- Lead sponsor
- SciPharm SàRL
- Results first posted
- 2019-06-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01416636?tab=results
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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