Trial · NCT01154231
BeneFIX Drug Use Results Survey [All-Case Surveillance]
NCT01154231, Completed, Pfizer; results first posted 2017-04-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BeneFIX Drug Use Results Survey [All-Case Surveillance]. Trials, record NCT01154231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01154231
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BeneFIX Drug Use Results Survey [All-Case Surveillance]
- NCT number
- NCT01154231
- Status
- Completed
- Enrollment
- 314 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hemophilia B
- Interventions
- Nonacog Alfa (Genetical Recombination)
- First posted
- 2010-06-30
- Last updated
- 2025-07-16
- Results first posted
- 2017-04-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy | 2 years for PTPs, 1 year for PUPs | Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing. |
| Primary | Number of Administrations Required for Hemostasis for Bleeding Events | 2 years for PTPs, 1 year for PUPs | Mean number of administrations for hemostasis in replacement therapy for bleeding events. |
| Secondary | Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes | 2 years for PTPs, 1 year for PUPs | Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy | 2 years for PTPs, 1 year for PUPs | Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis. | Bleeding events/year | MEDIAN |
| PRIMARY | Number of Administrations Required for Hemostasis for Bleeding Events | 2 years for PTPs, 1 year for PUPs | Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis. | administrations | MEAN |
| SECONDARY | Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes | 2 years for PTPs, 1 year for PUPs | Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis. | percentage | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy | BeneFIX (Nonacog Alfa) | 2.00 | Inter-Quartile Range 11.29 | Bleeding events/year | |
| Number of Administrations Required for Hemostasis for Bleeding Events | BeneFIX (Nonacog Alfa) | 1.8 | Full Range 4.18 | administrations | |
| Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes | BeneFIX (Nonacog Alfa) | 93.7 | 95% Confidence Interval 91.6 to 95.5 | percentage |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BeneFIX (Nonacog Alfa) | 314 | |
| Overall Study | COMPLETED | BeneFIX (Nonacog Alfa) | 312 | |
| Overall Study | NOT COMPLETED | BeneFIX (Nonacog Alfa) | 2 |
Source ClinicalTrials.gov
Adverse events31
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | BeneFIX (Nonacog Alfa) | 2 | 312 | |
| other | Urinary tract infection | Infections and infestations | BeneFIX (Nonacog Alfa) | 2 | 312 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | BeneFIX (Nonacog Alfa) | 2 | 312 | |
| other | Dizziness | Nervous system disorders | BeneFIX (Nonacog Alfa) | 2 | 312 | |
| other | Headache | Nervous system disorders | BeneFIX (Nonacog Alfa) | 2 | 312 | |
| other | Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | BeneFIX (Nonacog Alfa) | 2 | 312 | |
| other | Diarrhoea | Gastrointestinal disorders | BeneFIX (Nonacog Alfa) | 2 | 312 | |
| other | Rash | Skin and subcutaneous tissue disorders | BeneFIX (Nonacog Alfa) | 3 | 312 | |
| other | Adenovirus infection | Infections and infestations | BeneFIX (Nonacog Alfa) | 1 | 312 | |
| other | Bronchitis | Infections and infestations | BeneFIX (Nonacog Alfa) | 1 | 312 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BeneFIX (Nonacog Alfa) | ||
| Total, other adverse events | BeneFIX (Nonacog Alfa) | 35 | 312 |
| Total, serious adverse events | BeneFIX (Nonacog Alfa) | 5 | 312 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01154231
GET https://conductscience.org/api/trials/v1/NCT01154231/events?page=2