Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Participants Experiencing any Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality |
Number of participants experiencing any treatment-emergent SAEs and/or AEs, regardless of causality will be assessed. An AE is defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants Experiencing Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) |
Number of participants experiencing causally related SAEs and/or AEs will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants with Serious and/or Non-Serious Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs) |
Number of participants with serious and/or non-serious ARs plus suspected ARs will be assessed. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or an AE that begins during infusion of IP or within 72 hours following the end of IP infusion, or an AE for which causality assessment is missing or indeterminate. |
Throughout the study period of approximately 7 years |
|
| Primary |
Rate of Adverse Events (AEs) that may be a Result of Immune-Mediated Responses |
Rate of AEs that may be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex mediated reactions -local, Immune complex mediated reactions-systemic which will be expressed as the number of events per infusion and per participant-year will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions, Regardless of Causality |
Causality is a determination of whether there is a reasonable possibility that the IP is etiologically related to/associated with the AE. Number of treatment-emergent serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions, regardless of causality will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions |
Number of causally related serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Adverse Events (AEs) Temporally Associated with Infusions |
Number of AEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion will be assessed. |
During or within 72 hours after completion of an infusion |
|
| Primary |
Number of Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Associated with Infusions |
Number of serious and/or non-serious ARs plus suspected ARs associated with infusions will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Infusions Associated with One or More Systemic Adverse Events (AEs) |
Number of infusions associated with 1 or more systemic AEs will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Infusions Associated with One or More Local Infusion Site Reactions |
Number of infusions associated with 1 or more local infusion site reactions will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion was Interrupted or Stopped due to Intolerability and/or Adverse Events (AEs) |
Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Rates of Systemic and local Adverse Events (AEs), Regardless of Causality |
Rates of systemic and local AEs, regardless of causality will be expressed as number of events per infusion, per participant, and per participant-year. |
Throughout the study period of approximately 7 years |
|
| Primary |
Rates of Causally Related Systemic and Local Adverse Events (AEs) |
Rates of causally related systemic and local AEs, will be expressed as number of events per infusion, per participant, and per participant-year. |
Throughout the study period of approximately 7 years |
|
| Primary |
Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs) |
Rates of systemic and local adverse reactions (ARs) plus suspected ARs, will be expressed as number of events per infusion, per participant, and per participant-year. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study |
Number of participants with an adverse event (AE) that led to discontinuation from study will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Moderate or Severe Adverse Events (AEs) that may be a Result of Immune-Mediated Responses |
Number of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Rate per Infusion of Moderate or Severe Adverse Events (AEs) that may be a Result of Immune-Mediated Responses |
Rate per infusion of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants Experiencing Treatment-Emergent Local Infusion Site Reactions |
Number of participants experiencing treatment-emergent local infusion site reactions will be assessed. All local infusion site treatment-emergent AEs will be reported as adverse reactions. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants with Treatment-Emergent with Local Tolerability Events |
Number of participants with treatment-emergent with local tolerability events during the first 8 weeks of open-label extension study 161505 among participants originally randomized to placebo (no ramp up), versus during the 8 week-ramp-up period for participants originally randomized to HYQVIA in double-blind Study 161403 will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants in whom Infusion Rate was Reduced and/or the Infusion was Interrupted or Stopped due to Intolerability and/or Adverse Events (AEs) |
Number of participants in whom infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants with Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate per Site, and Infusion Volume per Site |
Number of participants experiencing local infusion reactions, as a function of dosing interval, infusion rate per site, and infusion volume per site will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants whose Anti-Hyaluronidase Antibody Titers Rise by Greater Than or Equal (> or =) ( 4 Fold from the Original Baseline Value from Study 161403 Using Combined Data from Both Studies (161403 and 161505) |
Number of participants whose anti-hyaluronidase antibody titers rise by > or = 4 fold from the original baseline value from study 161403 using combined data from both studies (161403 and 161505) will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Incidence of Binding Antibodies to rHuPH20 |
Incidence of binding antibodies to rHuPH20 will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Incidence of Neutralizing Antibodies to rHuPH20 |
Incidence of neutralizing antibodies to rHuPH20 will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants with a Decline of Anti-rHuPH20 Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or Study 161601 and/or to Less than (<)160 at the Study Completion or Early Discontinuation |
Number of participants with a decline of anti-rHuPH20 antibody titers to the antibody titer level at baseline in Study 161403 or Study 161601 and/or to <160 at the study completion or early discontinuation will be assessed. |
Throughout the study period of approximately 7 years |
|
| Primary |
Number of Participants who have Greater than (>) 10,000 Titer of Binding Antibodies to rHuPH20: Neutralizing Antibodies and Cross Reactivity with Hyal-1,2 and 4 |
Number of participants who have >10,000 titer of binding antibodies to rHuPH20: neutralizing antibodies and cross reactivity with Hyal-1,2 and 4 will be assessed. |
Throughout the study period of approximately 7 years |
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