Trial · NCT01338415
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation | Up to 62 weeks in average | The analysis was performed on the Safety population analysis set, including all patients who received at least one dose of study treatment and evaluated according to the study treatment that they received. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | At Month 12 | The intent to treat population was used. Where a missing visit score exists between two visits with scores, the missing score was imputed with the worse score of the non-missing scores; if the missing score was not between 2 visits with scores, it was replaced by the last non-missing score. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | At Month 18 | The intent to treat population was used. Where a missing visit score exists between two visits with scores, the missing score was imputed with the worse score of the non-missing scores; if the missing score was not between 2 visits with scores, it was replaced by the last non-missing score. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline up to 12 Months of Study Treatment in the Global Clinical Impression Scale (GCIS) | At Month 12 | The intent to treat population was used for these analyses. No imputation method was used. Only patients with available results at the corresponding time point are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline up to 18 Months of Study Treatment in the Global Clinical Impression Scale (GCIS) | At Month 18 | The intent to treat population was used. No imputation method was used. Only patients with available results at the corresponding time point are including in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients With Pulmonary Arterial Hypertension (PAH) Worsening Components up to the Last Day of Treatment + 7 Days | Up to 62 weeks in average | The intent to treat population was used | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Pulmonary Arterial Hypertension (PAH) Progression up to End of Treatment + 7 Days | From baseline to Month 18 | These are the numbers of patients at risk at the time of study treatment initiation in the FUTURE 3 core study | Percentage of patients free of events | NUMBER |
| OTHER_PRE_SPECIFIED | Overall Survival | From baseline to month 18 | These are the numbers of patients at risk at the time of study treatment initiation in the FUTURE 3 core study | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Exceptional Use Treatment Period (EUTP): Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) up to 7 Days After Permanent Discontinuation of Study Drug | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 7 Days After Permanent Discontinuation of Study Drug | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With AEs Leading to Premature Discontinuation of Study Drug | Up to 3 years and 4 months | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With SAEs From 7 up to 60 Days After Permanent Discontinuation of Study Drug | From 7 up to 60 days after permanent discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With Deaths | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With Adverse Events of Special Interest (AESI) | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With Treatment-emergent Marked Laboratory Abnormalities up to 7 Days After Permanent Discontinuation of Study Drug | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With Liver Function Abnormalities | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With Any Time Occurrence of Hemoglobin <=10 Gram Per Deciliter (g/dL) and <=8g/dL Between Baseline and up to 7 Days After End of Treatment (EOT) | Baseline, up to 7 days after end of treatment (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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