Evaluation of Safety and Efficacy of Deoxycholic Acid Inj... | NCT01305577

ID	Type	Description	Link
2010-020690-17	EudraCT Number

Status Module

Name	Class
Bayer	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Drug: Placebo
Deoxycholic Acid Injection 1 mg/cm²	Experimental	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Drug: Deoxycholic acid injection
Deoxycholic Acid Injection 2 mg/cm²	Experimental	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	Drug: Deoxycholic acid injection

Name	Type	Description	Arm Group Labels	Other Names
Deoxycholic acid injection	Drug		Deoxycholic Acid Injection 1 mg/cm² Deoxycholic Acid Injection 2 mg/cm²	ATX-101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response	A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.	Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Percentage of Participants With a Subject Self Rating Scale (SSRS) Response	A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.	Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a CR-SMFRS 2-grade Response	A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS).
Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
Body mass index (BMI) greater than 30.
Currently on or considering starting a weight reduction regimen.
Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
Previous randomization into this study or previous treatment with ATX-101.
Treatment with an investigational device or agent within 30 days of randomization.

Name	Affiliation	Role
Frederick Beddingfield, MD, PhD	Kythera Biopharmaceuticals, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Oudenaarde	Minderbroederstaraat	9700	Belgium
Investigational Site

PubMed Identifier	Type	Citation	Retractions
24984785	Derived	McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
FG001	Deoxycholic Acid Injection 2 mg/cm²

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
BG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
BG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.8± 10.94 BG00146.7± 9.78 BG00246.6± 10.17 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

18 - 50 years

Title	Measurements
	BG00077 BG00179 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00095 BG00195 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0000 BG0010 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00073.83± 11.518 BG00173.53± 12.413 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m²

Title

Denominators

Categories

Title	Measurements
	BG00025.94± 2.724 BG00125.66± 3.063 BG002

Fitzpatrick Skin Type

Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:

Type I: Pale white skin, blue/hazel eyes, blond/red hair; Always burns, does not tan.
Type II: Fair skin, blue eyes; Burns easily, tans poorly.
Type III: Darker white skin; Tans after initial burn.
Type IV: Light brown skin; Burns minimally, tans easily.
Type V: Brown skin; Rarely burns, tans darkly easily.
Type VI: Dark brown or black skin; Never burns, always tans darkly.

Number

participants

Title

Denominators

Categories

I-III

Title	Measurements
	BG000108 BG001

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 a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response

A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.

The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.

Intent-to-treat (ITT) population, which consisted of all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.

Posted

Number

percentage of participants

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

ID	Title	Description
OG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Units	Counts
Participants	OG000120 OG001121 OG002122

Title

Denominators

Categories

Title	Measurements
	OG00059.2 OG00165.3 OG00223.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo. An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.	Regression, Logistic	Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.	<0.001		Odds Ratio (OR)	4.73			2-Sided	95	2.70	8.28			The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.	No

Secondary

Percentage of Participants With a CR-SMFRS 2-grade Response

A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.

Intent-to-treat population; LOCF method was used to impute missing data

Posted

Number

percentage of participants

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

ID	Title	Description
OG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Primary

Percentage of Participants With a Subject Self Rating Scale (SSRS) Response

A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.

The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.

Intent-to-treat population; LOCF method was used to impute missing data

Posted

Number

percentage of participants

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

ID	Title	Description
OG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG002	Placebo

Secondary

Change From Baseline in CR-SMFRS Scores

A negative change from Baseline indicates improvement.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

units on a scale

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

ID	Title	Description
OG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Secondary

Change From Baseline in SSRS Scores

A positive change from Baseline indicates improvement.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

units on a scale

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

ID	Title	Description
OG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Secondary

Change From Baseline in Submental Fat Thickness

Submental thickness was measured using caliper devices.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

ID	Title	Description
OG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Secondary

Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)

The PR-SMFRS is based on the participant's response to the question "How much fat do you currently have under your chin?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score.

Intent-to-treat population with available data

Posted

Number

percentage of participants

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

ID	Title	Description
OG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Secondary

Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)

The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.

Not Posted

Jan 2016

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

Secondary

Change From Baseline in Self-rating of Attractiveness

Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:

How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are?" Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.

A positive change from Baseline indicates improvement.

Intent-to-treat population with available data

Posted

Mean

Standard Deviation

units on a scale

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

ID	Title	Description
OG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
OG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Secondary

Change From Baseline in Derriford Appearance Scale 24 (DAS24)

Not Posted

Jan 2016

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

Secondary

Change From Baseline in Body Image Quality of Life Inventory (BIQLI)

Not Posted

Jan 2016

Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Deoxycholic Acid Injection 1 mg/cm²	Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	1	119	111	119
EG001	Deoxycholic Acid Injection 2 mg/cm²	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	3	121	115	121
EG002	Placebo	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.	2	122	75	122

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Adhesions	Gastrointestinal disorders	MedDRA Version 14.1	Systematic Assessment	EG0000 affected119 at risk EG0011 affected121 at risk EG0020 affected122 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Systematic Assessment	EG0000 affected119 at risk EG0011 affected121 at risk EG0020 affected122 at risk
Non-Hodgkin's Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 14.1	Systematic Assessment	EG0000 affected119 at risk EG0010 affected121 at risk EG0021 affected122 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 14.1	Systematic Assessment	EG0000 affected119 at risk EG0011 affected121 at risk EG0020 affected122 at risk
Depression	Psychiatric disorders	MedDRA Version 14.1	Systematic Assessment	EG0001 affected119 at risk EG0010 affected121 at risk EG0020 affected122 at risk
Chronic Tonsillitis	Infections and infestations	MedDRA Version 14.1	Systematic Assessment	EG0000 affected119 at risk EG0010 affected121 at risk EG0021 affected122 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Systematic Assessment	EG0000 affected119 at risk EG0010 affected121 at risk EG0021 affected122 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection Site Pain	General disorders	MedDRA Version 14.1	Systematic Assessment	EG00092 affected119 at risk EG00197 affected121 at risk EG00231 affected122 at risk
Injection Site Haematoma	General disorders	MedDRA Version 14.1	Systematic Assessment	EG00065 affected119 at risk EG00162 affected121 at risk EG00248 affected122 at risk
Injection Site Swelling	General disorders	MedDRA Version 14.1	Systematic Assessment	EG00063 affected119 at risk EG00163 affected121 at risk EG00226 affected122 at risk
Injection Site Anaesthesia	General disorders	MedDRA Version 14.1	Systematic Assessment	EG00057 affected119 at risk EG00162 affected121 at risk EG0023 affected122 at risk
Injection Site Erythema	General disorders	MedDRA Version 14.1	Systematic Assessment	EG00046 affected119 at risk EG00145 affected121 at risk EG00228 affected122 at risk
Injection Site Induration	General disorders	MedDRA Version 14.1	Systematic Assessment	EG00022 affected119 at risk EG00133 affected121 at risk EG0023 affected122 at risk
Injection Site Oedema	General disorders	MedDRA Version 14.1	Systematic Assessment	EG00021 affected119 at risk EG00121 affected121 at risk EG00212 affected122 at risk
Injection Site Pruritus	General disorders	MedDRA Version 14.1	Systematic Assessment	EG00011 affected119 at risk EG0013 affected121 at risk EG0021 affected122 at risk
Injection Site Haemorrhage	General disorders	MedDRA Version 14.1	Systematic Assessment	EG0006 affected119 at risk EG0017 affected121 at risk EG0026 affected122 at risk
Injection Site Nodule	General disorders	MedDRA Version 14.1	Systematic Assessment	EG0001 affected119 at risk EG0019 affected121 at risk EG0020 affected122 at risk
Injection Site Warmth	General disorders	MedDRA Version 14.1	Systematic Assessment	EG0006 affected119 at risk EG0011 affected121 at risk EG0021 affected122 at risk
Headache	Nervous system disorders	MedDRA Version 14.1	Systematic Assessment	EG0008 affected119 at risk EG0017 affected121 at risk EG0027 affected122 at risk

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D002793	Cholic Acids
D001647	Bile Acids and Salts
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D002757	Cholanes