Trial · NCT03169972
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 | Number of Participants Who Discontinued the Use of Study Drug | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced spontaneous bleeding episodes during the administration period. | Bleeds per year | MEDIAN |
| PRIMARY | Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced breakthrough bleeding episodes during the administration period. | Bleeds per year | MEDIAN |
| PRIMARY | Duration of Treatment of Study Drug on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | days | MEAN |
| PRIMARY | Duration of Treatment of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | days | MEAN |
| PRIMARY | Dose Per Administration of Study Drug on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | IU per kilograms (kg) | MEAN |
| PRIMARY | Dose Per Administration of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | IU per kilograms (kg) | MEAN |
| SECONDARY | Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | Number of doses per a week | MEAN |
| PRIMARY | Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | Number of doses per a bleeding episode | MEAN |
| PRIMARY | Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced breakthrough bleeding episodes during the administration period. | Percentage of bleeding episodes | NUMBER |
| PRIMARY | Hemostatic Effectiveness of Study Drug on an On-Demand Regimen | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with on-demand regimen during the administration period. | Percentage of bleeding episodes | NUMBER |
| SECONDARY | Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE) | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | 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
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GET https://conductscience.org/api/trials/v1/NCT03169972/outcomes