Name (Synonyms) | Correlation |
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There is one clinical trial.
This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.
Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1-Start of data collection Time: BaselineDescription: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- Month 3 Time: Month 3Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- Month 6 Time: Month 6Description: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 2- Start of data collection Time: BaselineDescription: Median infusion volume per site
Measure: Infusion parameter 1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Start of data collection Time: BaselineDescription: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Month 3 Time: Month 3Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- Month 6 Time: Month 6Description: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 2- Start of data collection Time: BaselineDescription: Median infusion volume per infusion
Measure: Infusion parameter 1.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Start of data collection Time: BaselineDescription: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Month 3 Time: Month 3Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- Month 6 Time: Month 6Description: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 2- Start of data collection Time: BaselineDescription: Median number of infusion sites
Measure: Infusion parameter 2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Start of data collection Time: BaselineDescription: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Month 3 Time: Month 3Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- Month 6 Time: Month 6Description: Median infusion duration
Measure: Infusion parameter 3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median infusion duration
Measure: Infusion parameter 3: Cohort 2- Start of data collection Time: BaselineDescription: Median infusion duration
Measure: Infusion parameter 3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- Month 3 Follow-up Time: Month 3Description: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- Month 6 Follow-up Time: Month 6Description: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach participant's maximum infusion volume
Measure: Infusion parameter 3.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Start of data collection Time: BaselineDescription: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Month 3 Time: Month 3Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- Month 6 Time: Month 6Description: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 2- Start of data collection Time: BaselineDescription: Median number of infusions per month per participant
Measure: Infusion parameter 3.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Start of data collection Time: BaselineDescription: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Month 3 Time: Month 3Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- Month 6 Time: Month 6Description: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 2- Start of data collection Time: BaselineDescription: Median number of infusions to reach final dose interval per participant
Measure: Infusion parameter 3.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Start of data collection Time: BaselineDescription: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Month 3 Time: Month 3Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- Month 6 Time: Month 6Description: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 2- Start of data collection Time: BaselineDescription: Median maximal infusion rate per site
Measure: Infusion parameter 4.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Start of data collection Time: BaselineDescription: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Month 3 Time: Month 3Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- Month 6 Time: Month 6Description: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 2- Start of data collection Time: BaselineDescription: Number of infusions that are discontinued, slowed, or interrupted
Measure: Infusion parameter 4.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- Month 3 Time: Month 3Description: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- Month 6 Time: Month 6Description: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Median number of infusions to reach participant's maximum infusion rate
Measure: Infusion parameter 4.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Start of data collection Time: BaselineDescription: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Month 3 Time: Month 3Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- Month 6 Time: Month 6Description: Mean dose
Measure: Infusion parameter 5.1: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean dose
Measure: Infusion parameter 5.1: Cohort 2- Start of data collection Time: BaselineDescription: Mean dose
Measure: Infusion parameter 5.1: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Start of data collection Time: BaselineDescription: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Month 3 Time: Month 3Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- Month 6 Time: Month 6Description: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 2- Start of data collection Time: BaselineDescription: Mean dosing interval
Measure: Infusion parameter 5.2: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Start of data collection Time: BaselineDescription: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Month 3 Time: Month 3Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- Month 6 Time: Month 6Description: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 1- 12 Month final follow-up Time: 12 Month final follow-upDescription: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 2- Start of data collection Time: BaselineDescription: Mean number of dose adjustments
Measure: Infusion parameter 5.3: Cohort 2- 12 Month final follow-up Time: 12 Month final follow-upDescription: TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction
Measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1 Time: 12 Month final follow-upDescription: TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction
Measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2 Time: 12 Month final follow-upDescription: The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs
Measure: Life Quality Index (LSI): Cohort 1 Time: 12 Month final follow-upDescription: The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs
Measure: Life Quality Index (LSI): Cohort 2 Time: 12 Month final follow-upDescription: The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.
Measure: Treatment Preference Questionnaire: Cohort 1 Time: 12 Month final follow-upDescription: The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.
Measure: Treatment Preference Questionnaire: Cohort 2 Time: 12 Month final follow-up