Trial · NCT02004704
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) Except Infusion-Associated Reactions (IARs) | From the signature of informed consent up to 9 years or until olipudase alfa was commercially accessible, whichever came first | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With IARs | From the signature of informed consent up to 9 years or until olipudase alfa was commercially accessible, whichever came first | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | For Adults: Number of Participants With Abnormality in Complete Physical Examinations Including Abbreviated Physical Exam | Baseline (Day 1 of original study), Month 78 | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | For Pediatrics: Number of Participants With Abnormality in Complete Physical Examinations Including Abbreviated Physical Exam | Baseline (Day 1 of original study), Month 84 | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | For Adults: Number of Participants With Abnormality in Extended Neurological Examinations | Baseline (Day 1 of original study), Month 78 | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | For Pediatrics: Number of Participants With Abnormality in Extended Neurological Examinations | Baseline (Day 1 of original study), Month 84 | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs | Baseline (Day 1 of original study) up to 9 years or until olipudase alfa was commercially accessible, whichever came first | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With PCSA in Clinical Chemistry Parameters | Baseline (Day 1 of original study) up to 9 years or until olipudase alfa was commercially accessible, whichever came first | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With PCSA in Liver Function Tests | Baseline (Day 1 of original study) up to 9 years or until olipudase alfa was commercially accessible, whichever came first | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With PCSA in Hematology Parameters | Baseline (Day 1 of original study) up to 9 years or until olipudase alfa was commercially accessible, whichever came first | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With PCSA in Electrocardiogram (ECG) | Baseline (Day 1 of original study) up to 9 years or until olipudase alfa was commercially accessible, whichever came first | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | For Adults: Percent Change From Baseline in Pre-Infusion Plasma Ceramide at Month 90 | Baseline (Day 1 of original study) and Month 90 (pre-infusion) | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | percent change | MEAN |
| PRIMARY | For Pediatrics: Percent Change From Baseline in Pre-Infusion Plasma Ceramide at Month 66 | Baseline (Day 1 of original study) and Month 66 (pre-infusion) | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | percent change | MEAN |
| PRIMARY | Participants From Adult Study DFI13412: Number of Participants With Abnormal Liver Biopsy | Baseline (Day 1 of original study) and Month 36 | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participants From Pediatric Study DFI13803: Number of Participants With Abnormalities in Liver Ultrasound Doppler | Baseline (Day 1 of original study), Week 2 and Months 12, 18 and 24 | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Anti-Drug Antibodies (ADA) Against Olipudase Alfa | Baseline (Day 1 of original study) up to 9 years or until olipudase alfa was commercially accessible, whichever came first | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Spleen and Liver Volumes at Month 102 for Adults and Month 84 for Pediatrics | Baseline (Day 1 of original study), Month 102 for adults and Month 84 for pediatrics | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | percent change | MEAN |
| SECONDARY | Change From Baseline in Pulmonary Imaging by High Resolution Computed Tomography (HRCT) at Month 102 for Adults and Month 84 for Pediatrics | Baseline (Day 1 of original study), Month 102 for adults and Month 84 for pediatrics | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | score on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Percent Predicted Diffusing Capacity of Lungs For Carbon Monoxide (DLco) (Hemoglobin-Adjusted) at Month 78 for Adults and Month 84 for Pediatrics | Baseline (Day 1 of original study), Month 78 for adults and Month 84 for pediatrics | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Platelet Count at Month 90 for Adults and Month 78 for Pediatrics | Baseline (Day 1 of original study), Month 90 for adults (pre-infusion) and Month 78 for pediatrics (pre-infusion) | Results are based on the Safety analysis set which consisted of all enrolled participants who received at least 1 infusion (partial or total) of olipudase alfa in the current study. Only those participants with data collected at specified timepoints are reported. | percent change | MEAN |
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/NCT02004704/outcomes