Trial Outcomes & Findings for Registry For Patients Treated With BeneFix In Usual Care Setting In Germany (NCT NCT00714415)
NCT ID: NCT00714415
Last Updated: 2018-10-25
Results Overview
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
Recruitment status
COMPLETED
Target enrollment
80 participants
Primary outcome timeframe
Baseline until last visit (up to 8.7 years)
Results posted on
2018-10-25
Participant Flow
Participant milestones
| Measure |
BeneFIX: On-Demand
Participants were treated with intravenous (IV) injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 international units per kilogram \[IU/kg\]). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
55
|
|
Overall Study
COMPLETED
|
23
|
55
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
BeneFIX: On-Demand
Participants were treated with intravenous (IV) injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 international units per kilogram \[IU/kg\]). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
Baseline characteristics by cohort
| Measure |
BeneFIX: On Demand
n=25 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=55 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.2 years
STANDARD_DEVIATION 18.8 • n=99 Participants
|
16.0 years
STANDARD_DEVIATION 12.2 • n=107 Participants
|
17.3 years
STANDARD_DEVIATION 14.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline until last visit (up to 8.7 years)Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
Outcome measures
| Measure |
BeneFIX: On Demand
n=25 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=55 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
19 participants
|
49 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
8 participants
|
29 participants
|
PRIMARY outcome
Timeframe: Baseline until last visit (up to 8.7 years)Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious. Relatedness to BeneFIX was assessed by the investigator.
Outcome measures
| Measure |
BeneFIX: On Demand
n=25 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=55 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
2 participants
|
8 participants
|
|
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline until last visit (up to 8.7 years)Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.
FIX inhibitor development was defined as measured inhibitor titer of greater than (\>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
Outcome measures
| Measure |
BeneFIX: On Demand
n=25 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=55 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
|
1 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline until last visit (up to 8.7 years)Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity.
Outcome measures
| Measure |
BeneFIX: On Demand
n=25 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=55 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) of Special Interest
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: End of study visit (any time up to 8.7 years)Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor.
Outcome measures
| Measure |
BeneFIX: On Demand
n=23 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=54 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Investigator Assessment of Treatment Tolerability of Participants
Very good
|
16 participants
|
35 participants
|
|
Investigator Assessment of Treatment Tolerability of Participants
Good
|
7 participants
|
18 participants
|
|
Investigator Assessment of Treatment Tolerability of Participants
Moderate
|
0 participants
|
1 participants
|
|
Investigator Assessment of Treatment Tolerability of Participants
Poor
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: End of study visit (any time up to 8.7 years)Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor.
Outcome measures
| Measure |
BeneFIX: On Demand
n=22 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=52 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Participant Assessment of Treatment Tolerability
Very good
|
16 participants
|
37 participants
|
|
Participant Assessment of Treatment Tolerability
Good
|
6 participants
|
14 participants
|
|
Participant Assessment of Treatment Tolerability
Moderate
|
0 participants
|
1 participants
|
|
Participant Assessment of Treatment Tolerability
Poor
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline until last visit (up to 8.7 years)Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Participants documented all bleeding episodes in a diary during the study.
Outcome measures
| Measure |
BeneFIX: On Demand
n=22 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=54 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Mean Total Number of Bleeding Episodes in Participants
|
16.7 bleeding episodes
Standard Deviation 21.2
|
17.6 bleeding episodes
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Baseline until last visit (up to 8.7 years)Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
Outcome measures
| Measure |
BeneFIX: On Demand
n=22 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=54 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Mean Total Number of Bleeding Episodes Per Year in Participants
|
4.7 bleeding episodes per year
Standard Deviation 4.7
|
4.2 bleeding episodes per year
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, up to 8.7 yearsPopulation: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement was defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.
Outcome measures
| Measure |
BeneFIX: On Demand
n=15 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=34 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work
Improved
|
4 participants
|
7 participants
|
|
Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work
Unchanged
|
9 participants
|
20 participants
|
|
Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work
Worsened
|
2 participants
|
7 participants
|
SECONDARY outcome
Timeframe: End of study visit (any time up to 8.7 years)Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor.
Outcome measures
| Measure |
BeneFIX: On Demand
n=23 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=54 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Investigator Assessment of Treatment Efficacy of Participants
Very good
|
10 participants
|
24 participants
|
|
Investigator Assessment of Treatment Efficacy of Participants
Good
|
11 participants
|
30 participants
|
|
Investigator Assessment of Treatment Efficacy of Participants
Moderate
|
1 participants
|
0 participants
|
|
Investigator Assessment of Treatment Efficacy of Participants
Poor
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: End of study visit (any time up to 8.7 years)Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor.
Outcome measures
| Measure |
BeneFIX: On Demand
n=23 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=54 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Investigator Assessment of Treatment Handling of Participants
Very good
|
13 participants
|
34 participants
|
|
Investigator Assessment of Treatment Handling of Participants
Good
|
10 participants
|
20 participants
|
|
Investigator Assessment of Treatment Handling of Participants
Moderate
|
0 participants
|
0 participants
|
|
Investigator Assessment of Treatment Handling of Participants
Poor
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: End of study visit (any time up to 8.7 years)Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
Outcome measures
| Measure |
BeneFIX: On Demand
n=22 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=52 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Assessment of Treatment Efficacy by the Participants
Moderate
|
0 participants
|
0 participants
|
|
Assessment of Treatment Efficacy by the Participants
Very good
|
11 participants
|
27 participants
|
|
Assessment of Treatment Efficacy by the Participants
Good
|
10 participants
|
25 participants
|
|
Assessment of Treatment Efficacy by the Participants
Poor
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: End of study visit (any time up to 8.7 years)Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
Outcome measures
| Measure |
BeneFIX: On Demand
n=22 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=52 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Assessment of Treatment Handling by the Participants
Very good
|
13 participants
|
37 participants
|
|
Assessment of Treatment Handling by the Participants
Good
|
8 participants
|
15 participants
|
|
Assessment of Treatment Handling by the Participants
Moderate
|
1 participants
|
0 participants
|
|
Assessment of Treatment Handling by the Participants
Poor
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to 8.7 yearsPopulation: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied.
Outcome measures
| Measure |
BeneFIX: On Demand
n=23 Participants
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=54 Participants
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Investigator Assessment of Treatment Satisfaction of Participants
Very satisfied
|
12 participants
|
27 participants
|
|
Investigator Assessment of Treatment Satisfaction of Participants
Satisfied
|
9 participants
|
27 participants
|
|
Investigator Assessment of Treatment Satisfaction of Participants
Unsatisfied
|
1 participants
|
0 participants
|
|
Investigator Assessment of Treatment Satisfaction of Participants
Very unsatisfied
|
1 participants
|
0 participants
|
Adverse Events
BeneFIX: On Demand
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
BeneFIX: Prophylaxis
Serious events: 29 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BeneFIX: On Demand
n=25 participants at risk
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=55 participants at risk
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Middle ear disorder
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Cataract
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Adverse event
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Complication associated with device
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Condition aggravated
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
General physical health deterioration
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Impaired healing
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mass
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Necrosis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Polyp
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Abscess
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Blister infected
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Device related infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Impetigo
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pilonidal cyst
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Angiogram
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Inhibiting antibodies positive
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Extraskeletal ossification
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Synovial disorder
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Seizure
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Syncope
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Product Issues
Device defective
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar atrophy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Synovectomy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
BeneFIX: On Demand
n=25 participants at risk
Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
BeneFIX: Prophylaxis
n=55 participants at risk
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Ear pain
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Goitre
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Secondary hypogonadism
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eye haemorrhage
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eye swelling
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
3/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
4/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Haematochezia
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Loose tooth
|
8.0%
2/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Adverse event
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest discomfort
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest pain
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Impaired healing
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site haematoma
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Local swelling
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
4/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Medical device discomfort
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Peripheral swelling
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Polyp
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Allergy to venom
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Food allergy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Abscess
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cystitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Device related infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Furuncle
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastrointestinal infection
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gingivitis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Influenza
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Laryngitis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Lung infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Micrococcus infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Otitis media
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Superinfection
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.0%
2/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.5%
8/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
8.0%
2/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Concussion
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.0%
4/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.5%
14/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Fall
|
28.0%
7/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
38.2%
21/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Joint injury
|
12.0%
3/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.1%
5/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Laceration
|
12.0%
3/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.2%
10/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
21.8%
12/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.7%
7/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Limb injury
|
12.0%
3/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.2%
10/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
8.0%
2/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.7%
7/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Sports injury
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.2%
10/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
20.0%
5/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
21.8%
12/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Wound
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspiration joint
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood urine present
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Laboratory test abnormal
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Oesophagoscopy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Transaminases increased
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
30.9%
17/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
12.0%
3/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
21.8%
12/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
6/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
4/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
6/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
12.0%
3/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.1%
5/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
4/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.4%
9/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pelvic deformity
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue haemorrhage
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral fibroma
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
8.0%
2/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Piriformis syndrome
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Seizure
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Pregnancy, puerperium and perinatal conditions
Delivery
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Product Issues
Device issue
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Stress
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Breast haematoma
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.6%
2/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.7%
7/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subepidermal
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.5%
3/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Adenoidectomy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Artificial crown procedure
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Circumcision
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Ear tube insertion
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Eye operation
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Gingivectomy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Nail operation
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Tonsillectomy
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Haematoma
|
12.0%
3/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
21.8%
12/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Haemorrhage
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.7%
7/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/25 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.8%
1/55 • Baseline until last visit (up to 8.7 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER