A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults

Primary outcomes

1. Number of Participants with In Vitro Hypersensitivity to TAK-880 in Comparison to Gammagard S/D

   Time frame: Up to approximately 6 months

   Levels of in vitro hypersensitivity to TAK-880 in comparison to a reference product (Gammagard S/D) using hypersensitivity assays to address (but not limited to) immune cell activation and cytokine secretion, stratified by anti-IgA antibody levels will be evaluated during the study. Number of participants with In vitro hypersensitivity to TAK-880 in comparison to Gammagard S/D will be reported.

2. Number of Participants with Drug Hypersensitive Reactions to Immunoglobulin Products for Cohort 1 and 2

   Time frame: Up to approximately 6 months

   Number of Participants with drug hypersensitive reactions to immunoglobulin products who have previously received at least one infusion of Gammagard S/D in Cohorts 1 and 2 will be reported.

3. Number of Participants with History to Drug Hypersensitive Reactions

   Time frame: Up to approximately 6 months

   Number of participants with history to drug hypersensitive reactions will be reported.

4. Number of Participants Categorized by Clinical Characteristics

   Time frame: Up to approximately 6 months

   Number of participants categorized by clinical characteristics such as geographic location of residency, level of education will be reported.

5. Number of Participants Categorized by Treatment Patterns

   Time frame: Up to approximately 6 months

   Number of participants categorized by treatment patterns will be reported.

6. Health Related Quality of Life Measured by 36-Item Short Form Health Survey (SF-36)

   Time frame: Up to approximately 6 months

   SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL). SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning [ranges from 1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The total scores range from 0 to 100. Higher scores indicate better quality of life.

7. Health Related Quality of Life Measured by EuroQol 5 Dimensions Questionnaire (EQ-5D)

   Time frame: Up to approximately 6 months

   EQ-5D is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each participant, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.

8. Health Related Quality of Life Measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Validated Instrument for Cohort 1 and 2

   Time frame: Up to approximately 6 months

   TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). Scores for each domain are calculated by adding up the items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher score indicated greater satisfaction in that domain.

9. Patient Reported Outcomes (PROs) Using PID-Specific Life Quality Index (LQI) Questionnaire for Cohort 1 and 2

   Time frame: Up to approximately 6 months

   The PID-LQI questionnaire involves 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 poor" to 7: "Extremely good". The items measure the impact of the treatment on patient quality of life: factor I (treatment interference), factor II (therapy-related problems), factor III (therapy settings). Results range from 0 (maximal concern) to 100 (no concern). PROs using PID-specific LQI questionnaire in Cohort 1 and 2 will be reported.