Trial · NCT03417102
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Estimated Annualized Bleeding Rate (ABR) for Treated Bleeds During the Efficacy Period | From Day 29 up to Day 246 or up to the last day of bleeding follow up (any day up to Day 246), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | NUMBER |
| PRIMARY | Observed Annualized Bleeding Rate (ABR) for Treated Bleeds During the Efficacy Period | From Day 29 up to Day 246 or up to the last day of bleeding follow up (any day up to Day 246), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | MEAN |
| SECONDARY | Estimated Annualized Bleeding Rate (ABR) for Treated Bleeds During the Treatment Period | From Day 1 up to Day 246 or up to the last day of bleeding follow up (any day up to Day 246), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | NUMBER |
| SECONDARY | Observed Annualized Bleeding Rate (ABR) for Treated Bleeds During the Treatment Period | From Day 1 up to Day 246 or up to the last day of bleeding follow up (any day up to Day 246), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | MEAN |
| SECONDARY | Estimated Annualized Spontaneous Bleeding Rate for Treated Bleeds During Efficacy Period | From Day 29 up to Day 246 or up to the last day of bleeding follow up (any day up to Day 246), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | NUMBER |
| SECONDARY | Observed Annualized Spontaneous Bleeding Rate for Treated Bleeds During the Efficacy Period | From Day 29 up to Day 246 or up to the last day of bleeding follow up (any day up to Day 246), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | MEAN |
| SECONDARY | Estimated Annualized Joint Bleeding Rate for Treated Bleeds During the Efficacy Period | From Day 29 up to Day 246 or up to the last day of bleeding follow up (any day up to Day 246), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | NUMBER |
| SECONDARY | Observed Annualized Joint Bleeding Rate for Treated Bleeds During the Efficacy Period | From Day 29 up to Day 246 or up to the last day of bleeding follow up (any day up to Day 246), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | MEAN |
| SECONDARY | Health-related Quality of Life (HRQOL): Change From Baseline in Haemophilia Quality of Life Questionnaire for Adults (Haem-A-QOL) Physical Health Domain Score at Month 9 | Baseline (Day 1), Month 9 | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Health-related Quality of Life (HRQOL): Change From Baseline in Haem-A-QOL Total Score at Month 9 | Baseline (Day 1), Month 9 | Analysis was performed on ITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Estimated Annualized Bleeding Rate (ABR) for Treated Bleeds During the Onset Period | From Day 1 up to Day 28 or up to the last day of bleeding follow up (any day up to Day 28), whichever was the earliest | Analysis was performed on ITT population. | episodes per participant per year | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From Baseline (Day 1) up to 15 months (i.e. 9 months treatment period + 6-months follow-up) | Analysis was performed on safety analysis set that included all participants who received at least 1 dose of study drug or were randomized to on-demand arm, analyzed according to the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03417102/outcomes