Trial Outcomes & Findings for Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A (NCT NCT01454739)
NCT ID: NCT01454739
Last Updated: 2020-12-19
Results Overview
An inhibitor test result greater than or equal to (\>=) 0.6 Bethesda units per milliliter (BU/mL), identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. Data was summarized by treatment regimen for participants from 997HA301/997HA307/997HA309 combined and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
Approximately 5 years
Results posted on
2020-12-19
Participant Flow
Participants who completed studies 8HA02PED \[NCT01458106\], 997HA301 \[NCT01181128\]), 997HA307 (NCT02083965) and 997HA309 (NCT02502149) were expected to be eligible to enroll in this study.
Participant milestones
| Measure |
rFVIIIFc (Participants From Study 8HA02PED)
Participants received rFVIIIFc intravenously (IV) per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P(WP): rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding prevention dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
Participants received rFVIIIFc IV as per their assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 international unit per kilogram (IU/kg)-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than (\>)3 percent (%), if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
179
|
|
Overall Study
Tailored Prophylaxis
|
59
|
131
|
|
Overall Study
Weekly Prophylaxis
|
0
|
34
|
|
Overall Study
Personalized Prophylaxis
|
3
|
23
|
|
Overall Study
Episodic
|
0
|
13
|
|
Overall Study
Surgery Subgroup
|
2
|
26
|
|
Overall Study
COMPLETED
|
54
|
158
|
|
Overall Study
NOT COMPLETED
|
7
|
21
|
Reasons for withdrawal
| Measure |
rFVIIIFc (Participants From Study 8HA02PED)
Participants received rFVIIIFc intravenously (IV) per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P(WP): rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding prevention dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
Participants received rFVIIIFc IV as per their assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 international unit per kilogram (IU/kg)-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than (\>)3 percent (%), if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Other
|
3
|
5
|
|
Overall Study
Physician Decision
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Baseline characteristics by cohort
| Measure |
rFVIIIFc (Participants From Study 8HA02PED)
n=61 Participants
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants less than (\<)12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=179 Participants
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than \>3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
61 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 5 yearsPopulation: Safety analysis set included participants who received at least 1 dose of Recombinant Human Coagulation Factor VIII Fusion Protein(rFVIIIFc) in study 8HA01EXT.
An inhibitor test result greater than or equal to (\>=) 0.6 Bethesda units per milliliter (BU/mL), identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. Data was summarized by treatment regimen for participants from 997HA301/997HA307/997HA309 combined and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.
Outcome measures
| Measure |
rFVIIIFc (8HA02PED [<6 Years Old Age Cohort])
n=30 Participants
Participants with \< 6 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc (8HA02PED [6 to <12 Years Old Age Cohort])
n=31 Participants
Participants with 6 to \<12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=179 Participants
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than \>3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|---|
|
Number of Participants With Any Positive Inhibitor Development
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 5 yearsPopulation: Full Analysis Set (FAS) included all participants who received at least 1 dose of rFVIIIFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.
ABR is annualized number of bleeding episodes per participant per year. Bleeding episodes were classified as spontaneous if participant records bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity and as traumatic if participant records bleeding event when there is known reason for bleed. ABR=(Number of bleeding episodes during efficacy period (EP)/number of days during EP)\*365.25. EP reflects sum of all intervals of time during which participants were treated with rFVIIIFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. ABR was summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.
Outcome measures
| Measure |
rFVIIIFc (8HA02PED [<6 Years Old Age Cohort])
n=30 Participants
Participants with \< 6 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc (8HA02PED [6 to <12 Years Old Age Cohort])
n=31 Participants
Participants with 6 to \<12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=179 Participants
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than \>3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|---|
|
Annualized Bleeding Rate (ABR)
Tailored Prophylaxis
|
1.18 episodes per participant per year
Interval 0.6 to 2.37
|
1.59 episodes per participant per year
Interval 0.55 to 3.55
|
0.64 episodes per participant per year
Interval 0.0 to 2.84
|
|
Annualized Bleeding Rate (ABR)
Weekly Prophylaxis
|
—
|
—
|
1.90 episodes per participant per year
Interval 0.27 to 4.85
|
|
Annualized Bleeding Rate (ABR)
Personalized Prophylaxis
|
3.72 episodes per participant per year
Interval 3.35 to 4.09
|
1.01 episodes per participant per year
Interval 1.01 to 1.01
|
4.11 episodes per participant per year
Interval 0.64 to 8.78
|
|
Annualized Bleeding Rate (ABR)
Episodic
|
—
|
—
|
19.10 episodes per participant per year
Interval 15.12 to 30.46
|
SECONDARY outcome
Timeframe: Approximately 5 yearsPopulation: FAS included all participants who received at least 1 dose of rFVIIIFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.
Bleeding episodes were classified as spontaneous if participant records a bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity. In addition, location of bleed (joint, internal, skin/mucosa or muscle) were collected. Annualized spontaneous joint bleeding episodes=(Number of spontaneous joint bleeding episodes during efficacy period (EP)/number of days during EP)\*365.25. EP reflects sum of all intervals of time during which participants were treated with rFVIIIFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Bleeding episodes were summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.
Outcome measures
| Measure |
rFVIIIFc (8HA02PED [<6 Years Old Age Cohort])
n=30 Participants
Participants with \< 6 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc (8HA02PED [6 to <12 Years Old Age Cohort])
n=31 Participants
Participants with 6 to \<12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=179 Participants
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than \>3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|---|
|
Annualized Spontaneous Joint Bleeding Episodes
Tailored Prophylaxis
|
0.00 episodes per participant per year
Interval 0.0 to 0.55
|
0.00 episodes per participant per year
Interval 0.0 to 0.55
|
0.00 episodes per participant per year
Interval 0.0 to 0.63
|
|
Annualized Spontaneous Joint Bleeding Episodes
Weekly Prophylaxis
|
—
|
—
|
0.58 episodes per participant per year
Interval 0.0 to 1.9
|
|
Annualized Spontaneous Joint Bleeding Episodes
Personalized Prophylaxis
|
2.20 episodes per participant per year
Interval 1.34 to 3.07
|
0.00 episodes per participant per year
Interval 0.0 to 0.0
|
0.91 episodes per participant per year
Interval 0.0 to 2.84
|
|
Annualized Spontaneous Joint Bleeding Episodes
Episodic
|
—
|
—
|
9.22 episodes per participant per year
Interval 4.35 to 15.7
|
SECONDARY outcome
Timeframe: Approximately 5 yearsPopulation: Safety Analysis Set included participants who received at least 1 dose of rFVIIIFc in study 8HA01EXT. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.
An exposure day is a 24-hour period in which one or more rFVIIIFc injections are given. The total number of days of exposure to rFVIIIFc were summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.
Outcome measures
| Measure |
rFVIIIFc (8HA02PED [<6 Years Old Age Cohort])
n=30 Participants
Participants with \< 6 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc (8HA02PED [6 to <12 Years Old Age Cohort])
n=31 Participants
Participants with 6 to \<12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=179 Participants
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than \>3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|---|
|
Total Number of Exposure Days (EDs)
Personalized Prophylaxis
|
127.00 days
Interval 102.0 to 152.0
|
107.0 days
Interval 107.0 to 107.0
|
223.00 days
Interval 14.0 to 535.0
|
|
Total Number of Exposure Days (EDs)
Tailored Prophylaxis
|
287.00 days
Interval 18.0 to 447.0
|
373.00 days
Interval 85.0 to 467.0
|
257.00 days
Interval 4.0 to 660.0
|
|
Total Number of Exposure Days (EDs)
Weekly Prophylaxis
|
—
|
—
|
203.50 days
Interval 5.0 to 318.0
|
|
Total Number of Exposure Days (EDs)
Episodic
|
—
|
—
|
27.00 days
Interval 0.0 to 88.0
|
SECONDARY outcome
Timeframe: Approximately 5 yearsPopulation: FAS included all participants who received at least 1 dose of rFVIIIFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.
Annualized consumption = (total international unit per kilogram \[IU/kg\] of study treatment received during the efficacy period / total number of days during the efficacy period) multiplied by 365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFVIIIFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Annualized consumption was summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.
Outcome measures
| Measure |
rFVIIIFc (8HA02PED [<6 Years Old Age Cohort])
n=30 Participants
Participants with \< 6 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc (8HA02PED [6 to <12 Years Old Age Cohort])
n=31 Participants
Participants with 6 to \<12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=179 Participants
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than \>3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|---|
|
Annualized rFVIIIFc Consumption (International Units Per Kilogram [IU/kg])
Tailored Prophylaxis
|
5417.9 IU per kilogram per year
Interval 4683.4 to 6303.9
|
4989.7 IU per kilogram per year
Interval 4293.8 to 5842.4
|
4359.8 IU per kilogram per year
Interval 3993.8 to 5630.3
|
|
Annualized rFVIIIFc Consumption (International Units Per Kilogram [IU/kg])
Weekly Prophylaxis
|
—
|
—
|
3505.2 IU per kilogram per year
Interval 3267.9 to 3639.0
|
|
Annualized rFVIIIFc Consumption (International Units Per Kilogram [IU/kg])
Personalized Prophylaxis
|
5457.1 IU per kilogram per year
Interval 4435.0 to 6479.1
|
4572.3 IU per kilogram per year
Interval 4572.3 to 4572.3
|
3926.7 IU per kilogram per year
Interval 3261.8 to 6194.8
|
|
Annualized rFVIIIFc Consumption (International Units Per Kilogram [IU/kg])
Episodic
|
—
|
—
|
801.7 IU per kilogram per year
Interval 286.2 to 1057.7
|
SECONDARY outcome
Timeframe: Approximately 5 yearsPopulation: FAS- all participants who received at least 1 dose of rFVIIIFc. Data was summarized by treatment regimen for participants from 997HA301/997HA307/997HA309 combined and study from 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.
Participants were assessed for response to their rFVIIIFc regimen using following 4-point scale: 1=Excellent:bleeding episodes responded to less than or equal to (\<=)usual number of injections/dose of rFVIIIFc or rate of breakthrough bleeding during prophylaxis was \<= that usually observed; 2=Effective: most bleeding episodes responded to same number of injections and dose, but some required more injections or higher doses, or there was minor increase in rate of breakthrough; 3=Partially Effective: bleeding episodes most often required more injections and/or higher doses than expected or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses and 4=Ineffective: routine failure to control hemostasis/hemostatic control require additional agents. Total number of scale responses =total count of scale responses for all participants; multiple responses per participant including those at scheduled and unscheduled visits are counted.
Outcome measures
| Measure |
rFVIIIFc (8HA02PED [<6 Years Old Age Cohort])
n=428 Responses
Participants with \< 6 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc (8HA02PED [6 to <12 Years Old Age Cohort])
n=1252 Responses
Participants with 6 to \<12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than \>3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|---|
|
Physicians' Global Assessment of Participant's Response to rFVIIIFc Regimen Using a 4-Point Scale
Excellent
|
403 Responses
|
1061 Responses
|
—
|
|
Physicians' Global Assessment of Participant's Response to rFVIIIFc Regimen Using a 4-Point Scale
Effective
|
24 Responses
|
186 Responses
|
—
|
|
Physicians' Global Assessment of Participant's Response to rFVIIIFc Regimen Using a 4-Point Scale
Partially Effective
|
1 Responses
|
5 Responses
|
—
|
|
Physicians' Global Assessment of Participant's Response to rFVIIIFc Regimen Using a 4-Point Scale
Ineffective
|
0 Responses
|
0 Responses
|
—
|
SECONDARY outcome
Timeframe: Approximately 5 yearsPopulation: FAS was analyzed.Data was summarized by treatment regimen for participants from 997HA301/997HA307/997HA309 combined and by age cohort (\<6 years and 6 to\<12 years old) and treatment regimen for participants from 8HA02PED per planned analysis.Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.
Using eDiary, participant received rating for treatment response to any bleeding episode (BE) using 4-point scale- 1=Excellent: Abrupt pain relief and/or improvement in signs of bleeding within approximately (approx.) 8 hours (h) after initial injection (inj.); 2=Good: Definite pain relief and/or improvement in signs of bleeding within approx. 8h after an injection, but possibly requiring more than 1 injection after 24-48h for complete resolution; 3=Moderate: Probable/slight beneficial effect within 8h after initial injection and requires more than 1 injection and 4=None: No improvement, or condition worsens within approx. 8h after initial injection. This assessment was to be made approx. 8 to 12h from time the injection was given to treat BE and prior to any additional doses of rFVIIIFc given for same bleeding episode. Percentages are based on the number of bleeding episodes for which a response (excellent or good) was provided for the first injection during the efficacy period.
Outcome measures
| Measure |
rFVIIIFc (8HA02PED [<6 Years Old Age Cohort])
n=167 Injections
Participants with \< 6 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc (8HA02PED [6 to <12 Years Old Age Cohort])
n=172 Injections
Participants with 6 to \<12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=1734 Injections
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than \>3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
|---|---|---|---|
|
Participant's Assessment of Response (Excellent or Good Response) to rFVIIIFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale
Tailored Prophylaxis
|
139 Injections
|
155 Injections
|
475 Injections
|
|
Participant's Assessment of Response (Excellent or Good Response) to rFVIIIFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale
Weekly Prophylaxis
|
—
|
—
|
260 Injections
|
|
Participant's Assessment of Response (Excellent or Good Response) to rFVIIIFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale
Personalized Prophylaxis
|
9 Injections
|
1 Injections
|
318 Injections
|
|
Participant's Assessment of Response (Excellent or Good Response) to rFVIIIFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale
Episodic
|
—
|
—
|
338 Injections
|
Adverse Events
rFVIIIFc (Participants From Study 8HA02PED)
Serious events: 20 serious events
Other events: 49 other events
Deaths: 0 deaths
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
Serious events: 43 serious events
Other events: 110 other events
Deaths: 0 deaths
Overall(Participants From 8HA02PED/997HA301/997HA307/997HA309)
Serious events: 63 serious events
Other events: 159 other events
Deaths: 0 deaths
Participants From Study 8HA02PED- Surgery Subgroup
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants From 997HA301/997HA307/997HA309- Surgery Subgroup
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rFVIIIFc (Participants From Study 8HA02PED)
n=61 participants at risk
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=179 participants at risk
Participants received rFVIIIFc IV as per their assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 international unit per kilogram (IU/kg)-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than (\>)3 percent (%), if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc IV based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
Overall(Participants From 8HA02PED/997HA301/997HA307/997HA309)
n=240 participants at risk
All participants who received rFVIIIFc drug in study 8HA01EXT, from studies 8HA02PED and 97HA301/997HA307/997HA309. AEs emergent during major surgical/rehabilitation periods are excluded and are presented as separate groups.
|
Participants From Study 8HA02PED- Surgery Subgroup
n=2 participants at risk
Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFVIIIFc as appropriate for the type of surgery. Participants returned to a regular rFVIIIFc regimen once all dosing for the postoperative rehabilitation period had been completed.
|
Participants From 997HA301/997HA307/997HA309- Surgery Subgroup
n=26 participants at risk
Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFVIIIFc as appropriate for the type of surgery. Participants returned to a regular rFVIIIFc regimen once all dosing for the postoperative rehabilitation period had been completed.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
General disorders
Device breakage
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
General disorders
Device dislocation
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
General disorders
Infusion site mass
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
General disorders
Pyrexia
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Device related infection
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.1%
2/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.83%
2/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Influenza
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.83%
2/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Sinusitis
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Staphylococcal infection
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Tooth abscess
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Viral infection
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Fall
|
9.8%
6/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
2.5%
6/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
3.3%
2/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.83%
2/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Head injury
|
9.8%
6/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
2.9%
7/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.1%
2/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.83%
2/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Investigations
Body temperature increased
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.1%
2/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.83%
2/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
3.3%
2/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.7%
3/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
2.1%
5/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
6.1%
11/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
4.6%
11/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.1%
2/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.83%
2/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Nervous system disorders
Headache
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Psychiatric disorders
Depression
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.83%
2/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Surgical and medical procedures
Bone graft
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Surgical and medical procedures
Central venous catheter removal
|
6.6%
4/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.7%
4/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Surgical and medical procedures
Central venous catheterisation
|
3.3%
2/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.2%
3/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Surgical and medical procedures
Circumcision
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.1%
2/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.83%
2/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.56%
1/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Vascular disorders
Superior vena cava syndrome
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Vascular disorders
Superior vena caval stenosis
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.42%
1/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
3.8%
1/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
Other adverse events
| Measure |
rFVIIIFc (Participants From Study 8HA02PED)
n=61 participants at risk
Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of \>3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants \<12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.
|
rFVIIIFc(Participants From Studies 997HA301/997HA307/997HA309)
n=179 participants at risk
Participants received rFVIIIFc IV as per their assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 international unit per kilogram (IU/kg)-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than (\>)3 percent (%), if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc IV based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.
|
Overall(Participants From 8HA02PED/997HA301/997HA307/997HA309)
n=240 participants at risk
All participants who received rFVIIIFc drug in study 8HA01EXT, from studies 8HA02PED and 97HA301/997HA307/997HA309. AEs emergent during major surgical/rehabilitation periods are excluded and are presented as separate groups.
|
Participants From Study 8HA02PED- Surgery Subgroup
n=2 participants at risk
Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFVIIIFc as appropriate for the type of surgery. Participants returned to a regular rFVIIIFc regimen once all dosing for the postoperative rehabilitation period had been completed.
|
Participants From 997HA301/997HA307/997HA309- Surgery Subgroup
n=26 participants at risk
Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFVIIIFc as appropriate for the type of surgery. Participants returned to a regular rFVIIIFc regimen once all dosing for the postoperative rehabilitation period had been completed.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
5/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
8.9%
16/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
8.8%
21/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Vomiting
|
13.1%
8/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
3.4%
6/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
5.8%
14/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
General disorders
Pyrexia
|
9.8%
6/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
2.8%
5/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
4.6%
11/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Immune system disorders
Seasonal allergy
|
14.8%
9/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
2.8%
5/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
5.8%
14/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Gastroenteritis viral
|
9.8%
6/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.1%
2/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
3.3%
8/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Influenza
|
4.9%
3/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
7.8%
14/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
7.1%
17/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
6/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
20.7%
37/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
17.9%
43/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Pharyngitis
|
6.6%
4/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.1%
2/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
2.5%
6/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Tonsillitis
|
19.7%
12/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.1%
2/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
5.8%
14/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
21.3%
13/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
10.6%
19/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
13.3%
32/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Viral infection
|
6.6%
4/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
1.7%
3/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
2.9%
7/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.5%
7/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
2.9%
7/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Fall
|
18.0%
11/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
7.8%
14/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
10.4%
25/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.6%
1/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
8.4%
15/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
6.7%
16/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.6%
4/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
5.6%
10/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
5.8%
14/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.5%
7/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
11.2%
20/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
11.2%
27/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
5/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
6.1%
11/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
6.7%
16/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Nervous system disorders
Headache
|
16.4%
10/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
8.4%
15/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
10.4%
25/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.1%
8/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
5.0%
9/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
7.1%
17/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Vascular disorders
Hypertension
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
5.0%
9/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
3.8%
9/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
7.7%
2/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/61 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/179 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/240 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
0.00%
0/2 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
7.7%
2/26 • From signing Informed Consent Form (ICF) through follow-up (approximately 5 years)
Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
|
Additional Information
Bioverativ Study Medical Director
Bioverativ Therapeutics Inc.
Phone: 781-6631801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER