Study of Different Interventions to Reduce Bruising Follo... | NCT05419505

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: CCH-aaes Dose Evaluation	Experimental	Participants will be administered CCH-aaes at different doses. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.	Drug: CCH-aaes
Cohort 2: CCH-aaes Concentration Evaluation	Experimental	Participants will be administered CCH-aaes at different concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.	Drug: CCH-aaes
Cohort 3: CCH-aaes Injection Depth Evaluation	Experimental	Participants will be administered CCH-aaes using different injection depths. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.	Drug: CCH-aaes
Cohort 4: CCH-aaes Injection Method Evaluation	Experimental	Participants will be administered CCH-aaes using different injection methods. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.	Drug: CCH-aaes
Cohort 5: CCH-aaes and Diluent Additive Evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CCH-aaes	Drug	Administered by subcutaneous injection.	Cohort 1: CCH-aaes Dose Evaluation Cohort 2: CCH-aaes Concentration Evaluation Cohort 3: CCH-aaes Injection Depth Evaluation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection	The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.	3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS	The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. The investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit. Percentages are based on the number of participants with an assessment at specified timepoint.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Have a body mass index of 18 to <32 kilograms (kg)/meter (m)^2 and intends to maintain stable body weight during the study.
Have both buttocks with moderate or severe cellulite as reported by the investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
Have a Hexsel Cellulite Severity Scale (CSS) Total Score of ≤12.
Has a Fitzpatrick Skin Type of I-IV
Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of participation in the study.
Be willing and able to comply with the requirements of the study.

Key Exclusion Criteria:

Has systemic conditions (coagulation disorders, skin pigmentation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation.
Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.
Has any local (in the areas to be treated) conditions (thrombosis, post-thrombosis syndrome, vascular disorder, inflammation, active infection, active cutaneous alteration, tattoo or mole) that restricts study participation.
Requires antiplatelet medication, anticoagulants, or non-steroidal anti-inflammatory drugs during the study.
Any medications, supplements, or foods that have, or have been reported to have anticoagulant effects within 14 days of treatment.
Has received treatment with investigational treatment within 30 days before treatment.
Has used or intends to use any of the local applications, therapies, injections, or procedures for the treatment of cellulite on either buttock that would restrict study participation.
Intends to initiate an intensive sport or exercise program or intensive weight reduction program during the study.
Intends to engage in strenuous activity within 48 hours of study intervention administration.
Has recently tanned or intends to tan (outdoors or indoors) during the study.
Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH.
Has any condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
Has participated in a previous investigational study of CCH or received any collagenase treatments at any time prior to treatment in this study for the treatment of cellulite of the buttocks.

In addition to the applicable aforementioned exclusion criteria, participants enrolling in Cohort 7 will be excluded from study participation if the participant:

Has any of the following medical conditions:
1. history of venous or arterial thromboembolism or current thromboembolic disease.
2. history of or current renal impairment.
3. serum creatinine concentration > 1.4 milligram/deciliter at Screening.
Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment:
1. concurrently taking combination hormonal contraceptives.
2. concurrently undergoing hormone replacement therapy.
3. is a current smoker of nicotine or cannabinoids.
Participants in Cohort 7 should avoid smoking (including vaping, nicotine, or marijuana cigarettes) during the study.

Name	Affiliation	Role
David Hernandez	Endo USA Inc., a Keenova Therapeutics Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Endo Clinical Trial Site #6		Scottsdale	Arizona	85255	United States
Endo Clinical Trial Site #4

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: CCH-aaes Dose Evaluation	Test: Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams [mg]) but maintaining the labeled concentration (0.23 mg/milliliters [mL]). Control: Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 12, 2022	Dec 19, 2023

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: CCH-aaes Dose Evaluation	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams [mg]) but maintaining the labeled concentration (0.23 mg/milliliters [mL]). Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL)
BG001	Cohort 2: CCH-aaes Concentration Evaluation	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL). Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
BG002	Cohort 3: CCH-aaes Injection Depth Evaluation	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch. Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
BG003	Cohort 4: CCH-aaes Injection Method Evaluation	Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections. Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
BG004	Cohort 5: CCH-aaes and Diluent Additive Evaluation	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive. Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
BG005	Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation	Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart. Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.
BG006	Cohort 7a: CCH-aaes and Antifibrinolytic Agent	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen. Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
BG007	Cohort 7b: CCH-aaes and Antifibrinolytic Agent	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen. Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
BG008	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection

The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes.

The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side.

Percentages are based on the number of participants with an assessment at specified timepoint.

All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

percentage of participants

3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)

ID	Title	Description
OG000	Cohort 1: CCH-aaes Dose Evaluation	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams [mg]) but maintaining the labeled concentration (0.23 mg/milliliters [mL]). Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
OG001	Cohort 2: CCH-aaes Concentration Evaluation	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL). Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
OG002	Cohort 3: CCH-aaes Injection Depth Evaluation	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch. Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.
OG003	Cohort 4: CCH-aaes Injection Method Evaluation	Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections. Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.
OG004	Cohort 5: CCH-aaes and Diluent Additive Evaluation	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive. Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).

Units	Counts
Participants	OG00021 OG00112 OG0025 OG003

Title

Denominators

Categories

Title	Measurements
	OG00090.5(69.62 to 98.83) OG00125.0(5.49 to 57.19) OG00220.0(0.51 to 71.64) OG003

Secondary

Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS

The investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit.

Percentages are based on the number of participants with an assessment at specified timepoint.

All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint.

Posted

Number

95% Confidence Interval

percentage of participants

Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)

ID	Title	Description
OG000	Cohort 1: CCH-aaes Dose Evaluation	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).

Secondary

Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection

The investigator determined the degree of improvement of each buttock by comparing treated cellulite dimples from the Day 1 pre-treatment (Baseline) digital image of each buttock to the treated dimples observed in a live assessment.

The investigator determined the degree of improvement of each buttock with the I-GAIS, which uses a 7-point scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. The investigator compared the bruising of the left (test) buttock to the right (control) buttock.

A 1-level I-GAIS responder was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at an analysis visit for that treatment area.

Percentages are based on the number of participants with an assessment at specified timepoint.

All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid assessment at a treatment area after an injection of CCH-aaes.

For Cohort 7a, on Day 22, I-GAIS was only assessed for the investigational buttock (left buttock) and for Cohort 7b, on Day 22, I-GAIS was only assessed for the control buttock (right buttock).

Posted

Number

95% Confidence Interval

percentage of participants

Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts

ID	Title	Description
OG000	Cohort 1: CCH-aaes Dose Evaluation	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).

Secondary

Percentage of Participants With Injection Site Reactions

Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that occur or worsen (increase in severity) on the same day or after the study intervention administration on Day 1. Percent of participants with TEAEs of injection site reactions are presented by left buttock (test) and right buttock (control).

A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

All participants who received at least 1 injection of CCH-aaes.

Posted

Number

95% Confidence Interval

percentage of participants

From Day 1 (after dose) through Day 180

ID	Title	Description
OG000	Cohort 1: CCH-aaes Dose Evaluation	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).
OG001	Cohort 2: CCH-aaes Concentration Evaluation	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL). Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: CCH-aaes Dose Evaluation-Test (ISR)	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mL).	0	0	22	22
EG001	Cohort 1: CCH-aaes Dose Evaluation-Control (ISR)	Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).	0	0	22	22
EG002	Cohort 2: CCH-aaes Concentration Evaluation-Test (ISR)	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).	0	0	13	14
EG003	Cohort 2: CCH-aaes Concentration Evaluation -Control (ISR)	Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).	0	0	13	14
EG004	Cohort 3: CCH-aaes Injection Depth Evaluation-Test (ISR)	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.	0	0	5	5
EG005	Cohort 3: CCH-aaes Injection Depth Evaluation-Control (ISR)	Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch.	0	0	5	5
EG006	Cohort 4: CCH-aaes Injection Method Evaluation-Test (ISR)	Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.	0	0	7	7
EG007	Cohort 4: CCH-aaes Injection Method Evaluation-Control (ISR)	Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections.	0	0	7	7
EG008	Cohort 5: CCH-aaes and Diluent Additive Evaluation-Test (ISR)	Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.	0	0	10	10
EG009	Cohort 5: CCH-aaes and Diluent Additive Evaluation-Control (ISR)	Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).	0	0	10	10
EG010	Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation -Test (ISR)	Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.	0	0	19	19
EG011	Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation-Control (ISR)	Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart.	0	0	19	19
EG012	Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Test (ISR)	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.	0	0	7	7
EG013	Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Control (ISR)	Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).	0	0	6	7
EG014	Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Test (ISR)	Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.	0	0	7	7
EG015	Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Control (ISR)	Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL).	0	0	7	7
EG016	Cohort 1: Systemic/Non-ISR AEs	Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 1.	22	22	4	22
EG017	Cohort 2: Systemic/Non-ISR AEs	Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 2.	14	14	0	14
EG018	Cohort 3: Systemic/Non-ISR AEs	Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 3.	5	5	3	5
EG019	Cohort 4: Systemic/Non-ISR AEs	Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 4.	7	7	0	7
EG020	Cohort 5: Systemic/Non-ISR AEs	Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 5.	10	10	0	10
EG021	Cohort 6: Systemic/Non-ISR AEs	Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 6.	19	19	4	19
EG022	Cohort 7a: Systemic/Non-ISR AEs	Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 7a.	7	7	0	7
EG023	Cohort 7b: Systemic/Non-ISR AEs	Adverse events that affected participants as a whole (systemic events) or non-injection site reactions in Cohort 7b.	7	7	2	7

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injection site bruising	General disorders	MedDRA 25.0	Systematic Assessment		EG00022 affected22 at risk EG00122 affected22 at risk EG00213 affected14 at risk EG00313 affected14 at risk EG0045 affected5 at risk EG0055 affected5 at risk EG0060 affected7 at risk EG0070 affected7 at risk EG00810 affected10 at risk EG00910 affected10 at risk EG01019 affected19 at risk EG01119 affected19 at risk EG0120 affected7 at risk EG0130 affected7 at risk EG0147 affected7 at risk EG0157 affected7 at risk EG0160 affected0 at risk EG0170 affected0 at risk EG0180 affected0 at risk EG0190 affected0 at risk EG0200 affected0 at risk EG0210 affected0 at risk EG0220 affected0 at risk EG0230 affected0 at risk
Injection site pain	General disorders	MedDRA 25.0	Systematic Assessment		EG0007 affected22 at risk EG0018 affected22 at risk EG0020 affected14 at risk EG003
Injection site discolouration	General disorders	MedDRA 25.0	Systematic Assessment		EG00010 affected22 at risk EG00110 affected22 at risk EG0020 affected14 at risk EG003
Injection site haemorrhage	General disorders	MedDRA 25.0	Systematic Assessment	All AEs classified as injection site hemorrhage (preferred MedDRA term) for reporting purposes were identified with the verbatim term "ecchymosis" by investigators during the study.	EG0000 affected22 at risk EG0010 affected22 at risk EG0020 affected14 at risk EG003
Injection site nodule	General disorders	MedDRA 25.0	Systematic Assessment		EG0001 affected22 at risk EG0010 affected22 at risk EG0020 affected14 at risk EG003
Injection site mass	General disorders	MedDRA 25.0	Systematic Assessment		EG0004 affected22 at risk EG0014 affected22 at risk EG0020 affected14 at risk EG003
Injection site pruritus	General disorders	MedDRA 25.0	Systematic Assessment		EG0002 affected22 at risk EG0012 affected22 at risk EG0020 affected14 at risk EG003
Injection site swelling	General disorders	MedDRA 25.0	Systematic Assessment		EG0001 affected22 at risk EG0011 affected22 at risk EG0020 affected14 at risk EG003
Injection site papule	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected22 at risk EG0010 affected22 at risk EG0020 affected14 at risk EG003
Injection site erythema	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected22 at risk EG0010 affected22 at risk EG0020 affected14 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment		EG0000 affected22 at risk EG0010 affected22 at risk EG0020 affected14 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Insulin resistance	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 affected0 at risk EG0010 affected0 at risk EG0020 affected0 at risk EG003

ID	Term
D012877	Skin Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D050299	Fibrin Modulating Agents
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D006490	Hemostatics
D003029	Coagulants
D006401	Hematologic Agents
D045506	Therapeutic Uses