Trial Outcomes & Findings for CoolSculpting® Elite for Non-Invasive Fat Reduction (NCT NCT04897867)
NCT ID: NCT04897867
Last Updated: 2023-10-05
Results Overview
The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Results posted on
2023-10-05
Participant Flow
Participant milestones
| Measure |
CoolSculpting® Elite System
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|
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Overall Study
STARTED
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110
|
|
Overall Study
Safety Population
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110
|
|
Overall Study
Received Treatment in Session 2
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100
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Overall Study
Evaluable Population 1
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96
|
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Overall Study
Evaluable Population 3
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107
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Overall Study
COMPLETED
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99
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Overall Study
NOT COMPLETED
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11
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Reasons for withdrawal
| Measure |
CoolSculpting® Elite System
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|
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Overall Study
Withdrawal of Consent
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1
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Overall Study
Pregnancy
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1
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Overall Study
Lost to Follow-up
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7
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Overall Study
Reason not Specified
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2
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Baseline Characteristics
Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
Baseline characteristics by cohort
| Measure |
CoolSculpting® Elite System
n=110 Participants
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|
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Age, Continuous
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43.0 years
STANDARD_DEVIATION 12.05 • n=110 Participants
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Sex: Female, Male
Female
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82 Participants
n=110 Participants
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Sex: Female, Male
Male
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28 Participants
n=110 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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7 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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71 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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Race/Ethnicity, Customized
Race · Black or African American
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3 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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Race/Ethnicity, Customized
Race · Chinese
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11 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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Race/Ethnicity, Customized
Race · Middle Eastern
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1 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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|
Race/Ethnicity, Customized
Race · Taiwanese
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1 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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|
Race/Ethnicity, Customized
Race · White or Caucasian
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61 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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|
Race/Ethnicity, Customized
Race · Other
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2 Participants
n=79 Participants • Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites.
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PRIMARY outcome
Timeframe: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)Population: Evaluable Population 1 consisted of all participants who completed the cryolipolysis treatment plan to the midsection and completed the Cryolipolysis Satisfaction Questionnaire (CSQ)-Midsection Item #1 at 12 weeks after the final treatment session and who do not have any significant protocol deviation or violation.
The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Outcome measures
| Measure |
CoolSculpting® Elite System
n=96 Participants
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
|
CoolSculpting® Elite: Treatment Session 2
Participants who received a second CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|---|
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Percentage of Participants With "Satisfied" or "Very Satisfied" on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection
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83.3 percentage of participants
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—
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PRIMARY outcome
Timeframe: First treatment to Follow-up/Exit Visit (Week 12 + 14 days for those participants who received only 1 treatment session and Week 20 + 14 days for those participants who received 2 treatment sessions)Population: Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). AEs are reported separately for each of the two treatment sessions.
An AE will be considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date (and time, if known) of the first dose of study intervention. An AE will be considered a TESAE if it is a TEAE that additionally meets any SAE criterion. TEADE is defined as any TEAE with a reasonable possibility (Possible, Probable, or Causal relationship) that the event may have been caused by the study device. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made.
Outcome measures
| Measure |
CoolSculpting® Elite System
n=110 Participants
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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CoolSculpting® Elite: Treatment Session 2
n=100 Participants
Participants who received a second CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|---|
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Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Any Treatment-Emergent Adverse Event (TEAE)
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5 Participants
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5 Participants
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Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Any Treatment-Emergent Serious Adverse Event (TESAE)
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0 Participants
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0 Participants
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Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Any Unanticipated Treatment-Emergent Adverse Event (UTEAE)
|
0 Participants
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0 Participants
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Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Any Unanticipated Treatment-Emergent Serious Adverse Event (UTESAE)
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0 Participants
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0 Participants
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Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Any Treatment-Emergent Adverse Device Effect (TEADE)
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2 Participants
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4 Participants
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Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Any Treatment-Emergent Serious Adverse Device Effect (TESADE)
|
0 Participants
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0 Participants
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Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Any Unanticipated Treatment-Emergent Adverse Device Effect (UTEADE)
|
0 Participants
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0 Participants
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Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Any Unanticipated Treatment-Emergent Serious Adverse Device Effect (UTESADE)
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)Population: Evaluable Population 3 (N=107) consisted of all participants who completed the cryolipolysis treatment plan for any body areas (Midsection, Upper Arms, Inner Thighs, Outer Thighs and Submental Area) and do not have any significant protocol deviation or violation. Overall number analyzed is the number of participants available for analysis for CSQ-Overall Item 1 (n=53).
The CSQ-Overall is a 1-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® Elite treatment when midsection and one or more additional body area were selected for treatment. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure when considering the treated areas using a 5-item scale ranging from Very satisfied to Very dissatisfied.
Outcome measures
| Measure |
CoolSculpting® Elite System
n=53 Participants
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
|
CoolSculpting® Elite: Treatment Session 2
Participants who received a second CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|---|
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Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With "Satisfied" or "Very Satisfied" on CSQ-Overall Item 1
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83.0 percentage of participants
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—
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SECONDARY outcome
Timeframe: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)Population: Evaluable Population consisted of all participants who completed the cryolipolysis treatment plan to one or more additional body areas (Upper Arms, Inner Thighs, Outer Thighs, Submental Area), whether midsection treatment was completed or not, and do not have any significant protocol deviation or violation. Number analyzed for each category is the number of participants with available data for the respective individual body area.
The CSQ- Upper Arms, CSQ-Inner Thighs, CSQ-Outer Thighs, CSQ-Fat Under Chin are 1-item Patient-reported Outcome (PRO) instruments that measure participant's satisfaction with CoolSculpting® Elite treatment for the optional additional individual body area(s) treated. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure for the optional additional individual body area(s) treated on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Outcome measures
| Measure |
CoolSculpting® Elite System
n=58 Participants
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
|
CoolSculpting® Elite: Treatment Session 2
Participants who received a second CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|---|
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Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1
CSQ - Inner Thighs
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58.3 percentage of participants
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—
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Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1
CSQ - Outer Thighs
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33.3 percentage of participants
|
—
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Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1
CSQ - Upper Arms
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88.0 percentage of participants
|
—
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Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1
CSQ - Fat Under Chin
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83.3 percentage of participants
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—
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SECONDARY outcome
Timeframe: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who recieved 2 treatment sessions)Population: Evaluable Population 3 (N=107) consisted of all participants who completed the cryolipolysis treatment plan for any body areas (Midsection, Upper Arms, Inner Thighs, Outer Thighs and Submental Area) and do not have any significant protocol deviation or violation. Overall number analyzed is the number of participants evaluable for any of the body areas. Number analyzed for each category are the number of participants evaluable for the respective individual body area.
Success was defined as at least 70% correct identification of the pre-treatment images.
Outcome measures
| Measure |
CoolSculpting® Elite System
n=107 Participants
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
|
CoolSculpting® Elite: Treatment Session 2
Participants who received a second CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|---|
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Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
Midsection
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88.0 percentage of participants
|
—
|
|
Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
Inner Thighs
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60.0 percentage of participants
|
—
|
|
Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
Outer Thighs
|
100 percentage of participants
|
—
|
|
Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
Upper Arms
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
Submental Area
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66.7 percentage of participants
|
—
|
Adverse Events
CoolSculpting Elite: Treatment Session 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
CoolSculpting Elite: Treatment Session 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CoolSculpting Elite: Treatment Session 1
n=110 participants at risk
Participants who received one CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
|
CoolSculpting Elite: Treatment Session 2
n=100 participants at risk
Participants who received a second CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.
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|---|---|---|
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Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
0.91%
1/110 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
1.0%
1/100 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/110 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
1.0%
1/100 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
|
General disorders
MEDICAL DEVICE PAIN
|
0.00%
0/110 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
1.0%
1/100 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
|
Infections and infestations
INFLUENZA
|
0.91%
1/110 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
0.00%
0/100 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.91%
1/110 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
0.00%
0/100 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
|
Infections and infestations
SINUSITIS
|
0.91%
1/110 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
0.00%
0/100 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
|
Infections and infestations
TOOTH INFECTION
|
0.91%
1/110 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
0.00%
0/100 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/110 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
1.0%
1/100 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.91%
1/110 • Number of events 1 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
|
2.0%
2/100 • Number of events 2 • First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
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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