Trial Outcomes & Findings for JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance (NCT NCT05316233)
NCT ID: NCT05316233
Last Updated: 2026-09-03
Results Overview
ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme). A "responder" is a participant with at least 1-grade improvement on the ATNLS.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
159 participants
Primary outcome timeframe
Month 1
Results posted on
2026-09-03
Participant Flow
A total of 159 adult participants with moderate or severe transverse neck lines were randomly assigned; 105 in the treatment group and 54 in the control group. The ITT and safety populations included 159 participants each.
Participant milestones
| Measure |
VOLITE XC Group
VOLITE XC group participants received an initial treatment and an optional touch-up treatment at 30 days. Participants were then followed for up to 6 months after the last Control Period treatment (Control Period), at which time participants could receive optional Repeat Treatment and were followed for up to 4 months (Repeat Treatment Period). Participants who received Repeat Treatment exited the study at Month 4 after the Repeat Treatment.
|
Control Group
Control group participants received no treatment and were followed for up to 6 months after randomization (Control Period), and then either exited the study or received optional treatment (initial and touch-up, if needed) in the Optional Treatment Period. Participants were followed for up to 6 months after the last treatment in the Optional Treatment Period.
|
|---|---|---|
|
Control Period
STARTED
|
105
|
54
|
|
Control Period
COMPLETED
|
97
|
50
|
|
Control Period
NOT COMPLETED
|
8
|
4
|
|
Optional Treatment Period (Control Only)
STARTED
|
0
|
43
|
|
Optional Treatment Period (Control Only)
COMPLETED
|
0
|
38
|
|
Optional Treatment Period (Control Only)
NOT COMPLETED
|
0
|
5
|
|
Repeat Treatment Period (VOLITE XC Only)
STARTED
|
46
|
0
|
|
Repeat Treatment Period (VOLITE XC Only)
COMPLETED
|
45
|
0
|
|
Repeat Treatment Period (VOLITE XC Only)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
VOLITE XC Group
VOLITE XC group participants received an initial treatment and an optional touch-up treatment at 30 days. Participants were then followed for up to 6 months after the last Control Period treatment (Control Period), at which time participants could receive optional Repeat Treatment and were followed for up to 4 months (Repeat Treatment Period). Participants who received Repeat Treatment exited the study at Month 4 after the Repeat Treatment.
|
Control Group
Control group participants received no treatment and were followed for up to 6 months after randomization (Control Period), and then either exited the study or received optional treatment (initial and touch-up, if needed) in the Optional Treatment Period. Participants were followed for up to 6 months after the last treatment in the Optional Treatment Period.
|
|---|---|---|
|
Control Period
Lost to Follow-up
|
6
|
3
|
|
Control Period
Withdrawal by Subject
|
1
|
1
|
|
Control Period
Adverse Event
|
1
|
0
|
|
Optional Treatment Period (Control Only)
Lost to Follow-up
|
0
|
1
|
|
Optional Treatment Period (Control Only)
Withdrawal by Subject
|
0
|
3
|
|
Optional Treatment Period (Control Only)
Adverse Event
|
0
|
1
|
|
Repeat Treatment Period (VOLITE XC Only)
Adverse Event
|
1
|
0
|
Baseline Characteristics
JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance
Baseline characteristics by cohort
| Measure |
VOLITE XC Group
n=105 Participants
VOLITE XC group participants received an initial treatment and an optional touch-up treatment at 30 days. Participants were then followed for up to 6 months after the last Control Period treatment (Control Period), at which time participants could receive optional Repeat Treatment and were followed for up to 4 months (Repeat Treatment Period). Participants who received Repeat Treatment exited the study at Month 4 after the Repeat Treatment.
|
Control Group
n=54 Participants
Control group participants received no treatment and were followed for up to 6 months after randomization (Control Period), and then either exited the study or received optional treatment (initial and touch-up, if needed) in the Optional Treatment Period. Participants were followed for up to 6 months after the last treatment in the Optional Treatment Period.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 Years
STANDARD_DEVIATION 8.75 • n=136 Participants
|
47.1 Years
STANDARD_DEVIATION 9.11 • n=136 Participants
|
49.2 Years
STANDARD_DEVIATION 8.97 • n=272 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=136 Participants
|
53 Participants
n=136 Participants
|
154 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=136 Participants
|
18 Participants
n=136 Participants
|
55 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=136 Participants
|
36 Participants
n=136 Participants
|
104 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
7 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
11 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=136 Participants
|
6 Participants
n=136 Participants
|
11 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=136 Participants
|
41 Participants
n=136 Participants
|
124 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: Intent-to-Treat Population. Estimated responder rate is the average number of responders across multiple imputed datasets divided by total number of participants in the population.
ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme). A "responder" is a participant with at least 1-grade improvement on the ATNLS.
Outcome measures
| Measure |
VOLITE XC Group
n=105 Participants
VOLITE XC group participants received initial treatment and an optional touch-up treatment at 30 days. Participants were then followed for up to 6 months after the last Control Period treatment (Control Period), at which time participants could receive optional Repeat Treatment and were followed for up to 4 months (Repeat Treatment Period). Participants who received Repeat Treatment exited the study at Month 4 after the Repeat Treatment.
|
Control Group
n=54 Participants
Control group participants received no treatment and were followed for up to 6 months after randomization (Control Period), and then either exited the study or received optional treatment (initial and touch-up, if needed) in the Optional Treatment Period. Participants were followed for up to 6 months after the last treatment in the Optional Treatment Period.
|
Control Group (Optional Treatment Period)
This group includes participants who were randomized to the control group and received the optional VOLITE XC treatment after the Control Period. For this group, only AEs observed during the Optional Treatment Period are reported.
|
VOLITE XC Group (Repeat Treatment Period)
This group included participants randomized to the VOLITE XC group who received repeat treatment. For this group, only AEs recorded during the repeat treatment period are reported.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving "Responder" Status Based on Evaluating Investigator's (EI) Live Assessment of Transverse Neck Lines Using the Allergan Transverse Neck Lines Scale (ATNLS)
|
74.8 Percentage of participants
Interval 66.2 to 83.39
|
16.1 Percentage of participants
Interval 5.7 to 26.52
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to end of study (up to 14 Months)Population: Safety Population
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Outcome measures
| Measure |
VOLITE XC Group
n=105 Participants
VOLITE XC group participants received initial treatment and an optional touch-up treatment at 30 days. Participants were then followed for up to 6 months after the last Control Period treatment (Control Period), at which time participants could receive optional Repeat Treatment and were followed for up to 4 months (Repeat Treatment Period). Participants who received Repeat Treatment exited the study at Month 4 after the Repeat Treatment.
|
Control Group
n=54 Participants
Control group participants received no treatment and were followed for up to 6 months after randomization (Control Period), and then either exited the study or received optional treatment (initial and touch-up, if needed) in the Optional Treatment Period. Participants were followed for up to 6 months after the last treatment in the Optional Treatment Period.
|
Control Group (Optional Treatment Period)
n=43 Participants
This group includes participants who were randomized to the control group and received the optional VOLITE XC treatment after the Control Period. For this group, only AEs observed during the Optional Treatment Period are reported.
|
VOLITE XC Group (Repeat Treatment Period)
n=46 Participants
This group included participants randomized to the VOLITE XC group who received repeat treatment. For this group, only AEs recorded during the repeat treatment period are reported.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
All Treatment-Emergent Adverse Events
|
25 Participants
|
0 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Treatment-Related TEAEs
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
At Injection Site
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Not at Injection Site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Adverse Events of Special Interest (AESIs)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Treatment-related AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Treatment-Emergent Serious Adverse Events (TESAE)
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Treatment-Related TESAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Treatment-Related TESAE at Injection Site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Treatment-Related TESAE Not at Injection Site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
TEAEs leading to withdrawal of study treatment
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 1Population: Intent-to-Treat Population. Estimated responder rate is the average number of responders across multiple imputed datasets divided by total number of participants in the population.
GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse). A "responder" is a participant who shows improvement in the overall aesthetic assessment on the neck using GAIS.
Outcome measures
| Measure |
VOLITE XC Group
n=105 Participants
VOLITE XC group participants received initial treatment and an optional touch-up treatment at 30 days. Participants were then followed for up to 6 months after the last Control Period treatment (Control Period), at which time participants could receive optional Repeat Treatment and were followed for up to 4 months (Repeat Treatment Period). Participants who received Repeat Treatment exited the study at Month 4 after the Repeat Treatment.
|
Control Group
n=54 Participants
Control group participants received no treatment and were followed for up to 6 months after randomization (Control Period), and then either exited the study or received optional treatment (initial and touch-up, if needed) in the Optional Treatment Period. Participants were followed for up to 6 months after the last treatment in the Optional Treatment Period.
|
Control Group (Optional Treatment Period)
This group includes participants who were randomized to the control group and received the optional VOLITE XC treatment after the Control Period. For this group, only AEs observed during the Optional Treatment Period are reported.
|
VOLITE XC Group (Repeat Treatment Period)
This group included participants randomized to the VOLITE XC group who received repeat treatment. For this group, only AEs recorded during the repeat treatment period are reported.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving "Responder" Status for EI's Assessment of Global Aesthetic Improvement on the Neck Using the Global Aesthetic Improvement Scale (GAIS)
|
85.8 Percentage of participants
Interval 78.44 to 93.12
|
14.9 Percentage of participants
Interval 4.86 to 25.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Month 1Population: Intent-to-Treat Population. Participants with analysis values at both baseline and Month 1.
FACE-Q is a 10-item questionnaire assessing various aspects of the neck appearance. In the FACE-Q Appraisal of the Neck questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100. A higher score indicates greater satisfaction with facial appearance.
Outcome measures
| Measure |
VOLITE XC Group
n=93 Participants
VOLITE XC group participants received initial treatment and an optional touch-up treatment at 30 days. Participants were then followed for up to 6 months after the last Control Period treatment (Control Period), at which time participants could receive optional Repeat Treatment and were followed for up to 4 months (Repeat Treatment Period). Participants who received Repeat Treatment exited the study at Month 4 after the Repeat Treatment.
|
Control Group
n=49 Participants
Control group participants received no treatment and were followed for up to 6 months after randomization (Control Period), and then either exited the study or received optional treatment (initial and touch-up, if needed) in the Optional Treatment Period. Participants were followed for up to 6 months after the last treatment in the Optional Treatment Period.
|
Control Group (Optional Treatment Period)
This group includes participants who were randomized to the control group and received the optional VOLITE XC treatment after the Control Period. For this group, only AEs observed during the Optional Treatment Period are reported.
|
VOLITE XC Group (Repeat Treatment Period)
This group included participants randomized to the VOLITE XC group who received repeat treatment. For this group, only AEs recorded during the repeat treatment period are reported.
|
|---|---|---|---|---|
|
Change From Baseline to Month 1 in the Rasch-transformed Scores on FACE-Q Appraisal of the Neck Questionnaire
|
25.7 score on a scale
Standard Deviation 21.63
|
-0.7 score on a scale
Standard Deviation 15.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 1Population: Intent-to-Treat Population. Participants with analysis values at both baseline and specified analysis visit. Outcome measure is reported for the Volite XC treatment group only as specified per protocol.
A "responder" is a participant who shows improvement in the overall aesthetic assessment in the neck using GAIS. GAIS is a 5-point ordinal scale (2=Much Improved; -2=Much Worse).
Outcome measures
| Measure |
VOLITE XC Group
n=94 Participants
VOLITE XC group participants received initial treatment and an optional touch-up treatment at 30 days. Participants were then followed for up to 6 months after the last Control Period treatment (Control Period), at which time participants could receive optional Repeat Treatment and were followed for up to 4 months (Repeat Treatment Period). Participants who received Repeat Treatment exited the study at Month 4 after the Repeat Treatment.
|
Control Group
Control group participants received no treatment and were followed for up to 6 months after randomization (Control Period), and then either exited the study or received optional treatment (initial and touch-up, if needed) in the Optional Treatment Period. Participants were followed for up to 6 months after the last treatment in the Optional Treatment Period.
|
Control Group (Optional Treatment Period)
This group includes participants who were randomized to the control group and received the optional VOLITE XC treatment after the Control Period. For this group, only AEs observed during the Optional Treatment Period are reported.
|
VOLITE XC Group (Repeat Treatment Period)
This group included participants randomized to the VOLITE XC group who received repeat treatment. For this group, only AEs recorded during the repeat treatment period are reported.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving "Responder" Status for Participant's Assessment of Global Aesthetic Improvement on the Neck Using GAIS
|
89.4 Percentage of participants
Interval 81.3 to 94.78
|
—
|
—
|
—
|
Adverse Events
VOLITE XC Group (Control Period)
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Control Group (Control Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (Optional Treatment Period)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
VOLITE XC Group (Repeat Treatment Period)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VOLITE XC Group (Control Period)
n=105 participants at risk
This group includes participants randomized to the VOLITE XC group who received VOLITE XC treatment during the Control Period. For this group, only AEs observed during the Control Period were recorded.
|
Control Group (Control Period)
n=54 participants at risk
This group includes participants who were randomized to the control group. For this group, only AEs observed during the Control Period were recorded.
|
Control Group (Optional Treatment Period)
n=43 participants at risk
This group includes participants who were randomized to the control group and received the optional VOLITE XC treatment after the Control Period. For this group, only AEs observed during the Optional Treatment Period were recorded.
|
VOLITE XC Group (Repeat Treatment Period)
n=46 participants at risk
This group included participants randomized to the VOLITE XC group who received repeat treatment. For this group, only AEs recorded during the repeat treatment period were recorded.
|
|---|---|---|---|---|
|
Infections and infestations
CYSTITIS
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.95%
1/105 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
SINUSITIS
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
Other adverse events
| Measure |
VOLITE XC Group (Control Period)
n=105 participants at risk
This group includes participants randomized to the VOLITE XC group who received VOLITE XC treatment during the Control Period. For this group, only AEs observed during the Control Period were recorded.
|
Control Group (Control Period)
n=54 participants at risk
This group includes participants who were randomized to the control group. For this group, only AEs observed during the Control Period were recorded.
|
Control Group (Optional Treatment Period)
n=43 participants at risk
This group includes participants who were randomized to the control group and received the optional VOLITE XC treatment after the Control Period. For this group, only AEs observed during the Optional Treatment Period were recorded.
|
VOLITE XC Group (Repeat Treatment Period)
n=46 participants at risk
This group included participants randomized to the VOLITE XC group who received repeat treatment. For this group, only AEs recorded during the repeat treatment period were recorded.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
DERMOID CYST
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Eye disorders
DRY EYE
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Eye disorders
VITREOUS DETACHMENT
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
General disorders
INJECTION SITE BRUISING
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
General disorders
INJECTION SITE MASS
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
General disorders
INJECTION SITE PAPULE
|
3.8%
4/105 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
COVID-19
|
3.8%
4/105 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
INFLUENZA
|
1.9%
2/105 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
RHINITIS
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Injury, poisoning and procedural complications
FALL
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Injury, poisoning and procedural complications
NAIL INJURY
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Investigations
HEPATOBILIARY SCAN ABNORMAL
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Musculoskeletal and connective tissue disorders
TORTICOLLIS
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Nervous system disorders
REVERSIBLE CEREBRAL VASOCONSTRICTION SYNDROME
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.3%
1/43 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
1.9%
2/105 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.95%
1/105 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/46 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/105 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
0.00%
0/43 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
2.2%
1/46 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 7.1 months for the VOLITE XC Group (Control Period); 6.3 months for the Control Group (Control Period); 7.0 months for the Optional VOLITE XC Group (Optional Treatment Period); and 4.0 months for the VOLITE XC Repeat Treatment Group (Repeat Treatment Period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER