POST-MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF XYNTHA SOLOFUSE PREFILLED SYRINGE

Number of Participants Who Died Due to Adverse Events

时间窗: From the first administration of Xyntha up to 6 months

An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship.

Percentage of Participants With Bleeding Event

时间窗: From the first administration of Xyntha up to 6 months

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

时间窗: From the first administration of Xyntha up to 6 months

An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after first administration of Xyntha Solofuse up to 6 months. AEs included both serious and non-serious adverse event.

Number of Participants Who Discontinued Due to Adverse Events

时间窗: From the first administration of Xyntha up to 6 months

An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship.

Average Dose of Infusions Per Bleeding Event: Prophylactic Therapy

时间窗: From the first administration of Xyntha up to 6 months

The average dose of Xyntha per bleeding event according to prophylaxis therapy treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. Prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).

Number of Participants With Adverse Events (AEs) by Severity

时间窗: From the first administration of Xyntha up to 6 months

An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function, and was determined based on investigator's discretion.

Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events

时间窗: From the first administration of Xyntha up to 6 months

Treatment-related AE was any untoward medical occurrence attributed to Xyntha in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.

Number of Infusions Required to Treat Each New Bleeding Episode

时间窗: From the first administration of Xyntha up to 6 months

It was calculated as total number of injections given throughout the study divided by total number of bleeding events.

Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Bleeding

时间窗: From the first administration of Xyntha up to 6 months

The average dose of Xyntha per bleeding event was calculated as total dose of Xyntha throughout the study (in International Units \[IU\]) divided by total number of bleeding incidence. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding means treatment administered due to spontaneous bleeding or abrasion.

Total Factor VIII Consumption

时间窗: 6 months

Total factor VIII consumption for each participant was calculated by sum of the total amount of Xyntha Solofuse (in IU) infused for each Xyntha Solofuse infusion.

Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Surgery

时间窗: Within 24 hours of on-demand treatment (anytime within the observation period of 6 months)

LETE for on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as "no response" rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.

Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Bleeding

时间窗: Within 24 hours of on-demand treatment (anytime within the observation period of up to 6 months)

LETE for on-demand treatment ((administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as "no response" rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment) was defined as "no response" rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.

Annualized Bleeding Rates (ABRs)

时间窗: Within 48 hours after the prophylactic administration of Xyntha (within the duration of 6 months)

Annualized bleeding rate defined as number of bleeds under prophylactic setting (defined as bleeding occurred after 48 hours of prophylactic therapy \[administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding\]) divided by (/) \[(number of prophylactic therapy participants)\*0.5)\]

Number of Participants With Less Than Expected Therapeutic Effect (LETE): Prophylactic Therapy

时间窗: From the first administration of Xyntha up to 6 months

Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as: administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).

Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery

时间窗: From the first administration of Xyntha up to 6 months

On-demand treatment according to surgery: treatment to increase factor in preparation for surgery. Overall responses to all injection of Xyntha Solofuse prefilled syringe used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate and 4=no response, higher score = better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement starting after 8 hours following infusion, with \>=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion/condition worsens

Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding

时间窗: From the first administration of Xyntha up to 6 months

On-demand treatment according to bleeding: treatment administered for spontaneous bleeding/abrasion; not requiring surgery. Overall responses to all injection of Xyntha used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate,4=no response, higher score=better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement after 8 hours following infusion, with \>=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion, or condition worsens.

Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Surgery

时间窗: From the first administration of Xyntha up to 6 months

The average dose of Xyntha per bleeding event according to surgery in on-demand treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery means treatment to increase factor in preparation for surgery.