Trial · NCT02675465
Results by group67
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 67
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 1 | Number of subjects with TEAEs | 11 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 2 | Number of subjects with TEAEs | 6 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 3 | Number of subjects with TEAEs | 6 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 4 | Number of subjects with TEAEs | 6 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 1 | Number of subjects with TESAEs | 7 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 2 | Number of subjects with TESAEs | 4 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 3 | Number of subjects with TESAEs | 4 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 4 | Number of subjects with TESAEs | 6 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 1 | Number of subjects with AEs leading to discontinuation | 1 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 2 | Number of subjects with AEs leading to discontinuation | 2 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 3 | Number of subjects with AEs leading to discontinuation | 0 | Participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug | Cohort 4 | Number of subjects with AEs leading to discontinuation | 0 | Participants | |
| Plasma Human Acid α-glucosidase (GAA) Activity Levels as Measured by Maximum Observed Plasma Concentration (Cmax). | Cohort 1 | Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (1st dose) | 108836 | Geometric Coefficient of Variation 20.5 | nmol/mL/hr |
| Plasma Human Acid α-glucosidase (GAA) Activity Levels as Measured by Maximum Observed Plasma Concentration (Cmax). | Cohort 3 | Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (1st dose) | 132400 | Geometric Coefficient of Variation 14.3 | nmol/mL/hr |
| Plasma Human Acid α-glucosidase (GAA) Activity Levels as Measured by Maximum Observed Plasma Concentration (Cmax). | Cohort 1 | Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (3rd dose) | 119624 | Geometric Coefficient of Variation 25.7 | nmol/mL/hr |
| Plasma Human Acid α-glucosidase (GAA) Activity Levels as Measured by Maximum Observed Plasma Concentration (Cmax). | Cohort 3 | Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (3rd dose) | 105842 | Geometric Coefficient of Variation 15.4 | nmol/mL/hr |
| Plasma GAA Activity Levels as Measured by Time to Reach the Maximum Observed Plasma Concentration (Tmax). | Cohort 1 | Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (1st Dose) | 3.49 | Full Range 3.47 to 4.00 | h |
| Plasma GAA Activity Levels as Measured by Time to Reach the Maximum Observed Plasma Concentration (Tmax). | Cohort 3 | Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (1st Dose) | 3.97 | Full Range 3.47 to 4.00 | h |
| Plasma GAA Activity Levels as Measured by Time to Reach the Maximum Observed Plasma Concentration (Tmax). | Cohort 1 | Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (3rd Dose) | 3.57 | Full Range 3.35 to 4.00 | h |
| Plasma GAA Activity Levels as Measured by Time to Reach the Maximum Observed Plasma Concentration (Tmax). | Cohort 3 | Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (3rd Dose) | 3.66 | Full Range 3.50 to 3.98 | h |
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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