Secondary Immune Deficiency
Conditions
Brief summary
Number of Serious Bacterial Infections (SBIs) per Participant The SBIs includes: bacteraemia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.
Detailed description
Number of Infections per Participant, Number CTCAE >= Grade 3 Infections per Participant. Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling limiting self-care activities of daily living. Infections of CTCAE Grade 3 or worse will be reported., Number of Days Hospitalized due to Infections, Number of Days With Anti-infectives Use, Number of Infection-related Deaths and Complications, Number of Infection-related Requirement for Intravenous (IV)Therapy, Number of Infection-related Requirement for Hospitalization per Participant, Number of Participants with TEAEs, Serious Adverse SAEs, AESIs, Infusion Site Reaction and Other Local Reactions. In this study, thromboembolic events are treated as AESIs., Trough Concentrations of Serum IgG, Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau(AUC[0-t]), Maximal Serum Concentration (Cmax) of IgG, Time to Maximal Serum Concentration (Tmax) of IgG
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Serious Bacterial Infections (SBIs) per Participant The SBIs includes: bacteraemia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Infections per Participant, Number CTCAE >= Grade 3 Infections per Participant. Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling limiting self-care activities of daily living. Infections of CTCAE Grade 3 or worse will be reported., Number of Days Hospitalized due to Infections, Number of Days With Anti-infectives Use, Number of Infection-related Deaths and Complications, Number of Infection-related Requirement for Intravenous (IV)Therapy, Number of Infection-related Requirement for Hospitalization per Participant, Number of Participants with TEAEs, Serious Adverse SAEs, AESIs, Infusion Site Reaction and Other Local Reactions. In this study, thromboembolic events are treated as AESIs., Trough Concentrations of Serum IgG, Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau(AUC[0-t]), Maximal Serum Concentration (Cmax) of IgG, Time to Maximal Serum Con | — |