Trial Outcomes & Findings for Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe (NCT NCT03034044)
NCT ID: NCT03034044
Last Updated: 2023-11-13
Results Overview
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.
COMPLETED
106 participants
From the first administration of Xyntha up to 6 months
2023-11-13
Participant Flow
Participant milestones
| Measure |
Xyntha
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
Received Xyntha
|
105
|
|
Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Xyntha
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Overall Study
Enrolled, but not received Xyntha
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Xyntha
n=105 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Age, Customized
< 30 years
|
19 Participants
n=105 Participants
|
|
Age, Customized
30- 39 years
|
29 Participants
n=105 Participants
|
|
Age, Customized
40- 49 years
|
39 Participants
n=105 Participants
|
|
Age, Customized
50- 59 years
|
11 Participants
n=105 Participants
|
|
Age, Customized
>= 60 years
|
7 Participants
n=105 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=105 Participants
|
|
Duration of the disease, Continuous
|
32.4 Years
STANDARD_DEVIATION 16.9 • n=105 Participants
|
|
Genetic mutation of factor VIII
Yes
|
0 Participants
n=105 Participants
|
|
Genetic mutation of factor VIII
No
|
36 Participants
n=105 Participants
|
|
Genetic mutation of factor VIII
Unknown
|
69 Participants
n=105 Participants
|
|
Previous exposure to plasma-derived factor VIII
Yes
|
51 Participants
n=105 Participants
|
|
Previous exposure to plasma-derived factor VIII
No
|
34 Participants
n=105 Participants
|
|
Previous exposure to plasma-derived factor VIII
Unknown
|
20 Participants
n=105 Participants
|
|
Previous used factor VIII therapy
Yes
|
93 Participants
n=105 Participants
|
|
Previous used factor VIII therapy
No
|
12 Participants
n=105 Participants
|
|
Personal history of allergic reactions to factor VIII products
Yes
|
0 Participants
n=105 Participants
|
|
Personal history of allergic reactions to factor VIII products
No
|
105 Participants
n=105 Participants
|
|
Family history of hemophilia A
Yes
|
23 Participants
n=105 Participants
|
|
Family history of hemophilia A
No
|
82 Participants
n=105 Participants
|
|
Family history of factor VIII inhibitors
Yes
|
0 Participants
n=105 Participants
|
|
Family history of factor VIII inhibitors
No
|
105 Participants
n=105 Participants
|
|
Family history of allergic reactions to factor VIII products
Yes
|
0 Participants
n=105 Participants
|
|
Family history of allergic reactions to factor VIII products
No
|
105 Participants
n=105 Participants
|
|
Disease severity
Mild
|
13 Participants
n=105 Participants
|
|
Disease severity
Moderate
|
8 Participants
n=105 Participants
|
|
Disease severity
Severe
|
80 Participants
n=105 Participants
|
|
Disease severity
Unknown
|
4 Participants
n=105 Participants
|
|
Medical history
Yes
|
45 Participants
n=105 Participants
|
|
Medical history
No
|
60 Participants
n=105 Participants
|
|
Renal Disorder
Yes
|
2 Participants
n=105 Participants
|
|
Renal Disorder
No
|
103 Participants
n=105 Participants
|
|
Hepatic Disorder
Yes
|
17 Participants
n=105 Participants
|
|
Hepatic Disorder
No
|
88 Participants
n=105 Participants
|
|
Personal History of Allergic Reactions to Factor VIII Products (within 12 months)
Yes
|
2 Participants
n=105 Participants
|
|
Personal History of Allergic Reactions to Factor VIII Products (within 12 months)
No
|
103 Participants
n=105 Participants
|
|
Concomitant treatments
Yes
|
36 Participants
n=105 Participants
|
|
Concomitant treatments
No
|
69 Participants
n=105 Participants
|
|
Concomitant therapy
Yes
|
2 Participants
n=105 Participants
|
|
Concomitant therapy
No
|
103 Participants
n=105 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.
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.
Outcome measures
| Measure |
Xyntha
n=105 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
15 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Xyntha
n=105 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) by Severity
Moderate
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Mild
|
10 Participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Severe
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.
An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Xyntha
n=105 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants Who Discontinued Due to Adverse Events
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.
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.
Outcome measures
| Measure |
Xyntha
n=105 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events
AEs
|
2 Participants
|
|
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events
SAEs
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.
An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship.
Outcome measures
| Measure |
Xyntha
n=105 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants Who Died Due to Adverse Events
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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
Outcome measures
| Measure |
Xyntha
n=6 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery
Excellent
|
6 Participants
|
|
Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery
Good
|
0 Participants
|
|
Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery
Moderate
|
0 Participants
|
|
Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery
No response
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Xyntha
n=31 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding
Excellent
|
28 Participants
|
|
Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding
Good
|
3 Participants
|
|
Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding
Moderate
|
0 Participants
|
|
Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding
No response
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of on-demand treatment (anytime within the observation period of 6 months)Population: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Xyntha
n=6 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Surgery
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of on-demand treatment (anytime within the observation period of up to 6 months)Population: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Xyntha
n=31 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Bleeding
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
It was calculated as total number of injections given throughout the study divided by total number of bleeding events.
Outcome measures
| Measure |
Xyntha
n=31 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Infusions Required to Treat Each New Bleeding Episode
|
1.22 Infusions
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Xyntha
n=6 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Surgery
|
2619.29 IU/event
Standard Deviation 1089.07
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Xyntha
n=31 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Bleeding
|
2140.08 IU/event
Standard Deviation 640.32
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Xyntha
n=90 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Percentage of Participants With Bleeding Event
|
6.67 percentage of participants
|
PRIMARY outcome
Timeframe: Within 48 hours after the prophylactic administration of Xyntha (within the duration of 6 months)Population: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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 (/) \[(number of prophylactic therapy participants)\*0.5)\]
Outcome measures
| Measure |
Xyntha
n=90 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Annualized Bleeding Rates (ABRs)
|
13.33 bleeds per participant
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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).
Outcome measures
| Measure |
Xyntha
n=90 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Number of Participants With Less Than Expected Therapeutic Effect (LETE): Prophylactic Therapy
|
6 Participants
|
PRIMARY outcome
Timeframe: From the first administration of Xyntha up to 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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).
Outcome measures
| Measure |
Xyntha
n=90 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Average Dose of Infusions Per Bleeding Event: Prophylactic Therapy
|
1881.33 IU/event
Standard Deviation 531.88
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Xyntha
n=90 Participants
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
Total Factor VIII Consumption
|
106116.16 IU
Standard Deviation 55747.74
|
Adverse Events
Xyntha
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Xyntha
n=105 participants at risk
Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.
|
|---|---|
|
General disorders
Fever
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Cardiac disorders
Hypertension
|
1.9%
2/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Nervous system disorders
Dizziness
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
3/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Vascular disorders
Factor VIII antibody positive
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Vascular disorders
Haemorrhage NOS
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Gastrointestinal disorders
Periodontal destruction
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Skeletal Pain
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Infections and infestations
Sepsis
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
3.8%
4/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Renal and urinary disorders
Haematuria
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Renal and urinary disorders
Renal calculus
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis fungal
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Laceration
|
0.95%
1/105 • From the first administration of Xyntha Solofuse prefilled syringe up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER