Trial Outcomes & Findings for Sculptra Aesthetic Post-Approval Study (NCT NCT02425943)

Last Updated: 2023-07-27

Results Overview

Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to \[\>=\] 0.5 (cm); papule less than \[\<\] 0.5 cm). Percentage of participants with any injection site nodule and/or papule were reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

867 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2023-07-27

Participant Flow

The study was conducted at United States from 21 May 2015 to 28 May 2021.

A total of 867 participants were enrolled and treated in this study.

Participant milestones

Participant milestones
Measure	Fitzpatrick Skin Types I-III Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 milliliter (mL) deep dermal injections in a grid pattern, spaced at a distance of approximately 1 centimeter (cm) for up to 9 weeks.	Fitzpatrick Skin Type IV-VI Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Overall Study STARTED	557	310
Overall Study COMPLETED	421	240
Overall Study NOT COMPLETED	136	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Fitzpatrick Skin Types I-III Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 milliliter (mL) deep dermal injections in a grid pattern, spaced at a distance of approximately 1 centimeter (cm) for up to 9 weeks.	Fitzpatrick Skin Type IV-VI Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Overall Study Adverse Event	3	1
Overall Study Lost to Follow-up	59	37
Overall Study Protocol Violation	4	1
Overall Study Withdrawal by Subject	64	31
Overall Study Other	6	0

Baseline Characteristics

Sculptra Aesthetic Post-Approval Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fitzpatrick Skin Type I-III n=557 Participants Participants with Fitzpatrick Skin Type I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=310 Participants Participants with Fitzpatrick Skin Type IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Total n=867 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 9.25 • n=5 Participants	52.6 years STANDARD_DEVIATION 9.56 • n=7 Participants	54.6 years STANDARD_DEVIATION 9.48 • n=5 Participants
Sex: Female, Male Female	524 Participants n=5 Participants	272 Participants n=7 Participants	796 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	38 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=5 Participants	123 Participants n=7 Participants	177 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	503 Participants n=5 Participants	187 Participants n=7 Participants	690 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	88 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) White	551 Participants n=5 Participants	203 Participants n=7 Participants	754 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Fitzpatrick Classification Skin Type Type I	32 Participants n=5 Participants	0 Participants n=7 Participants	32 Participants n=5 Participants
Fitzpatrick Classification Skin Type Type II	212 Participants n=5 Participants	0 Participants n=7 Participants	212 Participants n=5 Participants
Fitzpatrick Classification Skin Type Type III	313 Participants n=5 Participants	0 Participants n=7 Participants	313 Participants n=5 Participants
Fitzpatrick Classification Skin Type Type IV	0 Participants n=5 Participants	168 Participants n=7 Participants	168 Participants n=5 Participants
Fitzpatrick Classification Skin Type Type V	0 Participants n=5 Participants	96 Participants n=7 Participants	96 Participants n=5 Participants
Fitzpatrick Classification Skin Type Type VI	0 Participants n=5 Participants	46 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Intent to treat (ITT) Population included all participants who received at least one injection of study drug.

Outcome measures

Outcome measures
Measure	Fitzpatrick Skin Types I-III n=557 Participants Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=310 Participants Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Percentage of Participants With Any Injection Site Nodule and/or Papule	30.52 percentage of participants	24.84 percentage of participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: ITT Population included all participants who receive at least one injection of study drug.

AEIs means: "serious or non-serious adverse event that is one of scientific and medical concern specific to the sponsor's product for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Examples of AEIs were hypertrophic scarring, keloid formation, hypersensitivity reactions, skin necrosis, unexpected change in wrinkle contour, granuloma, changes in the skin pigmentation at the site of injection compared to adjacent. Percentage of participants with any AEIs (other than injection site nodule and/or papule) were reported.

Outcome measures

Outcome measures
Measure	Fitzpatrick Skin Types I-III n=557 Participants Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=310 Participants Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Percentage of Participants With Any Adverse Events of Interest (AEIs)	30.9 Percentage of participants	25.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Months 6,13 and Years 2,3 4,5

Population: ITT Population included all participants who received at least one injection of study drug. "Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for given time points.

NLF severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.

Outcome measures

Outcome measures
Measure	Fitzpatrick Skin Types I-III n=504 Participants Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=271 Participants Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Month 6	-1.73 Score on a scale Standard Deviation 0.826	-1.82 Score on a scale Standard Deviation 0.847
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Month 13	-1.74 Score on a scale Standard Deviation 0.785	-1.70 Score on a scale Standard Deviation 0.801
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 2	-1.60 Score on a scale Standard Deviation 0.833	-1.63 Score on a scale Standard Deviation 0.836
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 3	-1.16 Score on a scale Standard Deviation 0.908	-1.25 Score on a scale Standard Deviation 0.937
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 4	-0.80 Score on a scale Standard Deviation 0.927	-0.95 Score on a scale Standard Deviation 0.916
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 5	-0.47 Score on a scale Standard Deviation 0.883	-0.62 Score on a scale Standard Deviation 0.994

SECONDARY outcome

Timeframe: Baseline, Months 6,13 and Years 2,3 4,5

The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. The physician assessed the left side and the right side of the participant's face using the 5-point scale where scoring of wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the investigator at defined timepoints. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Fitzpatrick Skin Types I-III n=128 Participants Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=29 Participants Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Month 6	-1.54 Score on a scale Standard Deviation 0.835	-1.88 Score on a scale Standard Deviation 0.988
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Month 13	-1.49 Score on a scale Standard Deviation 0.924	-1.96 Score on a scale Standard Deviation 0.849
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 2	-1.47 Score on a scale Standard Deviation 0.935	-1.89 Score on a scale Standard Deviation 0.801
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 3	-1.30 Score on a scale Standard Deviation 1.038	-1.74 Score on a scale Standard Deviation 0.818
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 4	-0.93 Score on a scale Standard Deviation 1.179	-1.38 Score on a scale Standard Deviation 1.044
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 5	-0.62 Score on a scale Standard Deviation 1.255	-1.08 Score on a scale Standard Deviation 1.283

SECONDARY outcome

Timeframe: Baseline, Months 6,13 and Years 2,3 4,5

Marionette Lines severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.

Outcome measures

Outcome measures
Measure	Fitzpatrick Skin Types I-III n=313 Participants Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=116 Participants Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Month 6	-1.72 Score on a scale Standard Deviation 0.831	-1.87 Score on a scale Standard Deviation 0.798
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Month 13	-1.65 Score on a scale Standard Deviation 0.866	-1.76 Score on a scale Standard Deviation 0.825
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 3	-1.13 Score on a scale Standard Deviation 1.023	-1.24 Score on a scale Standard Deviation 1.003
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 2	-1.52 Score on a scale Standard Deviation 0.904	-1.59 Score on a scale Standard Deviation 0.858
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 4	-0.77 Score on a scale Standard Deviation 1.077	-0.93 Score on a scale Standard Deviation 0.989
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 5	-0.41 Score on a scale Standard Deviation 1.110	-0.50 Score on a scale Standard Deviation 0.945

SECONDARY outcome

Timeframe: Baseline, Months 6,13 and Years 2,3 4,5

Chin Crease severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.

Outcome measures

Outcome measures
Measure	Fitzpatrick Skin Types I-III n=200 Participants Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=79 Participants Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Month 6	-1.54 Score on a scale Standard Deviation 0.945	-1.72 Score on a scale Standard Deviation 0.861
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Month 13	-1.46 Score on a scale Standard Deviation 0.992	-1.71 Score on a scale Standard Deviation 0.921
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 2	-1.37 Score on a scale Standard Deviation 1.029	-1.61 Score on a scale Standard Deviation 0.987
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 3	-0.99 Score on a scale Standard Deviation 1.066	-1.22 Score on a scale Standard Deviation 1.027
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 4	-0.75 Score on a scale Standard Deviation 1.075	-0.86 Score on a scale Standard Deviation 1.014
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5 At Year 5	-0.40 Score on a scale Standard Deviation 1.172	-0.49 Score on a scale Standard Deviation 1.048

SECONDARY outcome

Timeframe: At 6,13 months, 2, 3, 4 and 5 years

Population: ITT Population included all participants who receive at least one injection of study drug. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and here "number analyzed" signifies participants who were evaluable for this outcome measure for given time points.

Efficacy was assessed by overall facial improvement assessed live by the Investigator assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a subjective test. The investigator independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement.

Outcome measures

Outcome measures
Measure	Fitzpatrick Skin Types I-III n=557 Participants Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=310 Participants Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Month 6 : Improved	99.4 percentage of participants	99.6 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Year 3 : Not Improved	9.4 percentage of participants	7.7 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Month 6 : Not Improved	0.6 percentage of participants	0.4 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Month 13 : Improved	99.2 percentage of participants	99.6 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Month 13 : Not Improved	0.8 percentage of participants	0.4 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Year 2 : Improved	96.6 percentage of participants	96.0 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Year 2 : Not Improved	3.4 percentage of participants	4.0 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Year 3 : Improved	90.6 percentage of participants	92.3 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Year 4 : Improved	80.6 percentage of participants	82.9 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Year 4 : Not Improved	19.4 percentage of participants	17.1 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Year 5 : Improved	69.6 percentage of participants	67.5 percentage of participants
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale Year 5 : Not Improved	30.4 percentage of participants	32.5 percentage of participants

SECONDARY outcome

Timeframe: At 6,13 months, 2, 3, 4 and 5 years

Efficacy was assessed by overall facial improvement assessed live by the participants assessment of facial appearance including the GAIS. The GAIS is a subjective test. The participant independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement (Range 0 to 3).

Outcome measures

Outcome measures
Measure	Fitzpatrick Skin Types I-III n=506 Participants Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=273 Participants Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Year 2 : Improved	91.0 percentage of participants	92.9 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Year 2: Not Improved	9.0 percentage of participants	7.1 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Year 3 : Improved	85.6 percentage of participants	88.0 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Year 4 : Not Improved	27.0 percentage of participants	23.2 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Year 5: Not Improved	33.7 percentage of participants	33.8 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Year 3: Not Improved	14.4 percentage of participants	12.0 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Year 4 : Improved	73.0 percentage of participants	76.8 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Year 5 : Improved	66.3 percentage of participants	66.3 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Month 6 : Improved	97.2 percentage of participants	97.8 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Month 6 : Not Improved	2.8 percentage of participants	2.2 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Month 13 : Improved	97.4 percentage of participants	97.4 percentage of participants
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale At Month 13 : Not Improved	2.6 percentage of participants	2.6 percentage of participants

Adverse Events

Fitzpatrick Skin Types I-III

Serious events: 39 serious events

Other events: 315 other events

Deaths: 3 deaths

Fitzpatrick Skin Type IV-VI

Serious events: 11 serious events

Other events: 150 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fitzpatrick Skin Types I-III n=557 participants at risk Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=310 participants at risk Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
Congenital, familial and genetic disorders Granuloma	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.65% 2/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.65% 2/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage IV	0.18% 1/557 • Number of events 1 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Slipping rib syndrome	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Diverticulitis	0.36% 2/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Appendicitis	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Bacterial infection	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Cellulitis	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Corona virus infection	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Pneumonia	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Urinary tract infection	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
General disorders Death	0.36% 2/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
General disorders Chest pain	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
General disorders Pain	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Injury, poisoning and procedural complications Compression fracture	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Injury, poisoning and procedural complications Multiple fractures	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Injury, poisoning and procedural complications Nerve injury	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Injury, poisoning and procedural complications Patella fracture	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Injury, poisoning and procedural complications Rib fracture	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Injury, poisoning and procedural complications Spinal fracture	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Gastrointestinal disorders Colitis ulcerative	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Gastrointestinal disorders Crohn's disease	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Hepatobiliary disorders Cholelithiasis	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Nervous system disorders Cerebellar haemorrhage	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Nervous system disorders Transient ischaemic attack	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.36% 2/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Cardiac disorders Palpitations	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Congenital, familial and genetic disorders Pancreas divisum	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Eye disorders Retinal artery occlusion	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Immune system disorders Anaphylactic reaction	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Metabolism and nutrition disorders Dehydration	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Metabolism and nutrition disorders Metabolic acidosis	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Reproductive system and breast disorders Uterine haemorrhage	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Skin and subcutaneous tissue disorders Granuloma skin	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Surgical and medical procedures Knee operation	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Vascular disorders Haematoma	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Vascular disorders Hypotension	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Nervous system disorders Multiple sclerosis	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.

Measure	Fitzpatrick Skin Types I-III n=557 participants at risk Participants with Fitzpatrick Skin Types I-III received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.	Fitzpatrick Skin Type IV-VI n=310 participants at risk Participants with Fitzpatrick Skin Types IV-VI received four Sculptra Aesthetic intra-dermal injections with 3-week intervals of multiple 0.1 to 0.2 mL deep dermal injections in a grid pattern, spaced at a distance of approximately 1 cm for up to 9 weeks.
General disorders Implant site nodule	17.1% 95/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	13.9% 43/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
General disorders Implant site papules	18.1% 101/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	13.5% 42/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Nasopharyngitis	3.6% 20/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	1.6% 5/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Sinusitis	3.6% 20/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	1.6% 5/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Bronchitis	2.3% 13/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	1.6% 5/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Influenza	1.3% 7/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	2.3% 7/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Skin and subcutaneous tissue disorders Acne	1.6% 9/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	2.3% 7/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 11/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.5% 14/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	2.5% 14/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Vascular disorders Hypertension	3.4% 19/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Endocrine disorders Hypothyroidism	2.2% 12/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Urinary tract infection	1.6% 9/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
General disorders Corona virus infection	1.1% 6/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
General disorders Upper respiratory tract infection	1.3% 7/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.65% 2/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Infections and infestations Oral herpes	0.36% 2/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Skin and subcutaneous tissue disorders Dermatitis	1.1% 6/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	1.1% 6/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.90% 5/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	1.3% 4/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	1.3% 7/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.65% 2/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.3% 7/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.36% 2/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	1.3% 4/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Injury, poisoning and procedural complications Meniscus injury	1.1% 6/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.65% 2/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.72% 4/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	1.3% 4/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Respiratory, thoracic and mediastinal disorders Cough	1.3% 7/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Psychiatric disorders Depression	1.3% 7/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.32% 1/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Immune system disorders Seasonal allergy	0.72% 4/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.97% 3/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
General disorders Implant site pain	1.6% 9/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	1.3% 4/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
General disorders Implant site discolouration	0.18% 1/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	1.6% 5/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	1.1% 6/557 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.	0.00% 0/310 • Up to 5 years ITT Population included all participants who received at least one injection of study drug.