Trial · NCT01485796
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Related Systemic Adverse Events (Excluding Infections) | 7 months (per subject) | |
| Primary | Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | A point estimate and 95% confidence interval for the rate of related systemic adverse events per infusion was derived using a Poisson model. |
| Secondary | Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2 | 6 months (per subject) | |
| Secondary | Proportion of Subjects Who Maintain a Treatment Interval of 3 or 4 Weeks in Epoch 2 for 24 Weeks | 6 months (per subject) | |
| Secondary | Number of Related Local Adverse Events (Excluding Infections) | 7 months (per subject) | |
| Secondary | Rate of Related Local Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | A point estimate and 95% confidence interval for the rate of related local adverse events per infusion was derived using a Poisson model. |
| Secondary | Number of All Related Adverse Events (Excluding Infections) | 7 months (per subject) | |
| Secondary | Rate of All Adverse Events (Excluding Infections) Per Infusion | 7 months (per subject) | A point estimate and 95% confidence interval for the rate of adverse events per infusion was derived using a Poisson model. |
| Secondary | Number of Subjects Who Develop Neutralizing Antibodies to rHuPH20 | 7 months (per subject) | |
| Secondary | Trough Levels of Immunoglobulin G (IgG) | 7 months (per subject) | IgG trough levels at the beginning of Study Epoch 1 (previous immunoglobulin treatment) and at the end of Study Epoch 2 were analyzed. |
| Secondary | Number of Infusions Per Month in Epoch 1 and Epoch 2 | 7 months (per subject) | Non-parametric descriptive statistics (median, range) are provided. |
| Secondary | Number of Infusion Sites (Needle Sticks) Per Month in Epoch 1 and Epoch 2 | 7 months (per subject) | Non-parametric descriptive statistics (median, range) are provided. |
| Secondary | Duration of Infusion in Epoch 1 and Epoch 2 | 7 months (per subject) | Non-parametric descriptive statistics (median, range) are provided. |
| Secondary | Maximum Infusion Rate in Epoch 1 and Epoch 2 | 7 months (per subject) | Non-parametric descriptive statistics (median, range) are provided. |
| Secondary | Number of Weeks to Reach Final 3 or 4-week Dose Interval | 7 months (per subject) | Non-parametric descriptive statistics (median, range) are provided. |
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.
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GET https://conductscience.org/api/trials/v1/NCT01485796/registered