Single or Repeat Dose of G03-52-01 in Adult Subjects | NCT05348993 | Trialant
NCT05348993
Sponsor
U.S. Army Medical Research and Development Command
Status
Completed
Last Update Posted
Feb 17, 2026Actual
Enrollment
622Actual
Phase
Phase 2
Conditions
Healthy
Botulinum Toxin
Interventions
G03-52-01
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05348993
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
G03-52-01-002
Secondary IDs
Not provided
Brief Title
Single or Repeat Dose of G03-52-01 in Adult Subjects
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of G03-52-01 in Adult Subjects
Acronym
Not provided
Organization
U.S. Army Medical Research and Development CommandFED
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 15, 2022Actual
Primary Completion Date
Feb 18, 2025Actual
Completion Date
Feb 18, 2025Actual
First Submitted Date
Mar 31, 2022
First Submission Date that Met QC Criteria
Apr 21, 2022
First Posted Date
Apr 27, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jan 16, 2026
Results First Submitted that Met QC Criteria
Feb 11, 2026
Results First Posted Date
Feb 17, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 11, 2026
Last Update Posted Date
Feb 17, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
U.S. Army Medical Research and Development CommandFED
Collaborators
Name
Class
United States Department of Defense
FED
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A Phase 2, randomized, double-blind, placebo-controlled single or repeat dose trial
Detailed Description
A Phase 2, multicenter, randomized, double-blinded, placebo-controlled study to evaluate a single (100 mg) or repeat dose (50 mg and 100 mg) of G03-52-01 administered by IM injection(s) in adult subjects. Approximately 625 subjects will be enrolled in this study.
Conditions Module
Conditions
Healthy
Botulinum Toxin
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
622Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: 50 mg G03-52-01
Experimental
Participants will receive a 50 mg dose of G03-52-01 on Days 1 and 45, administered by IM injection.
Drug: G03-52-01
Cohort 2: 100 mg G03-52-01
Experimental
Participants will receive a 100 mg dose of G03-52-01 on Days 1 and 45, administered by IM injection.
Drug: G03-52-01
Cohort 3: Placebo
Placebo Comparator
Participants will receive placebo on Days 1 and 45, administered by IM injection.
Drug: Placebo
Cohort 4: 100 mg G03-52-01
Experimental
Participants will receive a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Drug: G03-52-01
Cohort 4: Placebo
Placebo Comparator
Participants will receive placebo on Day 1, administered by IM injection.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
G03-52-01
Drug
G03-52-01 administered intramuscularly
Cohort 1: 50 mg G03-52-01
Cohort 2: 100 mg G03-52-01
Cohort 4: 100 mg G03-52-01
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any unfavourable and unintended sign, symptom, or disease temporarily associated with the use of investigational product (IP), whether or not related to the IP.
A SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a congenital abnormality/birth defect, or caused any persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Clinically significant changes in physical examination, vital signs, and clinical safety laboratory values were included as AEs.
Cohorts 1-3: 240 days; Cohort 4: 120 days
Cohorts 1-2 Only: Percentage of Participants With Target Protective Concentration Neutralizing Antibody Concentration (NAC) Value > 0.02 U/mL (Botulinum Neurotoxin [BoNT]/A) or > 0.03 U/mL (BoNT/B) at Day 45 and Day 90
Pharmacodynamic (PD) samples were tested using the Battelle Mouse Neutralization Assay (MNA) for serotypes A and B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
Day 45 and Day 90
Cohort 4 Only: Percentage of Participants With Target Protective Concentration NAC Value > 0.02 U/mL (BoNT/A) or > 0.03 U/mL (BoNT/B) at 4 and 8 Hours Post Dose
PD samples were tested using the MNA for serotypes A and B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
4 and 8 hours post dose on Day 1
Secondary Outcomes
Measure
Description
Time Frame
Cohorts 1-2 Only: Percentage of Participants With Target Protective Concentration NAC Value > 0.02 U/mL (BoNT/A) or > 0.03 U/mL (BoNT/B) at Day 120
PD samples were tested using the MNA for serotypes A and B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Informed consent understood and signed prior to screening procedures.
Assessed by the Investigator to be a healthy male or healthy, non-pregnant, non-lactating female between the ages of 18 and 65 inclusive on the day of dosing.
Able and willing to comply and be available for all protocol procedures and follow-up for the duration of the study.
Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2.
Females of child-bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1 prior to dosing.
- A woman is considered of childbearing potential unless post-menopausal (≥ 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation.
If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use medically effective contraception (methods with a failure rate of < 1% per year when used consistently and correctly) during participation in the study. Acceptable methods include:
Hormonal contraception including implants, injections or oral
Two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)
Intrauterine device (IUD) or intrauterine system
Screening clinical laboratory results within normal ranges or are no greater than a Grade 1 and deemed not clinically significant by Medical Monitor (MM) and Principal Investigator (PI). Any subjects with results that are Grade 2 or above according to Appendix B will be excluded.
- Laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or due to laboratory error may be repeated once.
The urine drug screen is negative.
For Cohorts 1-3, if a subject has a positive urine drug screen that the PI believes is caused by a currently prescribed medication, (except for THC), the PI may enroll the subject if they meet all inclusion criteria, and none of the exclusion criteria.
For Cohort 4, if a subject has a positive urine drug screen that the PI believes is caused by a currently prescribed medication or positive for THC, the PI may enroll the subject if they meet all other inclusion criteria and none of the exclusion criteria.
Breathalyzer test is negative.
Available for follow-up for the duration of the study.
Agrees not to participate in vigorous activity 2 days prior to dosing and 2 days post-dose Day 1 and Day 45 for Cohorts 1-3 and Day 1 for Cohort 4, per Investigator discretion.
Exclusion Criteria:
History of a chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject.
- Chronic medical conditions include but are not limited to diabetes; Asthma requiring use of medication in the year before screening; Autoimmune disorder such as lupus, Wegener's, rheumatoid arthritis, thyroid disease; coronary artery disease; chronic hypertension; History of malignancy except low-grade (squamous and basal cell) skin cancer thought to be cured; chronic renal, hepatic, pulmonary, or endocrine disease (except previous asthma which has required no treatment for the past year).
Known history of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins.
- Severe allergic reactions are defined as any of the following: anaphylaxis, urticaria, or angioedema.
Known allergic reactions to any of the study product components present in the formulation or in the processing.
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds).
Clinically significant abnormal electrocardiogram (ECG) at screening.
- Clinically significant abnormal ECG results include but are not limited to: complete left or right bundle branch block; other ventricular conduction block except for incomplete RBB; 2nd degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern of ST elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator.
Positive serology results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
Febrile illness with temperature ≥38°C within 7 days of dosing. Subjects with acute febrile illness within 7 days of dosing may be rescreened no earlier than 7 days following resolution of symptoms.
Female subjects that are pregnant or breastfeeding or intending to become pregnant within the projected duration of the trial starting from the Screening visit until last dose.
Donation of blood or blood product within 56 days of enrollment.
Is currently participating or has participated in a study with an investigational product (IP) within 28 days preceding Day 1 (documented receipt of placebo in a previous trial would be permissible for trial eligibility)
Plans to enroll in another clinical trial that could interfere with safety assessment of the IP at any time during the study period.
- Includes trials that have a study intervention such as a drug, biologic, or device only
Treatment with a mAB within 3 months of Day 1.
Receipt of antibody (e.g., tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG], intravenous immunoglobulin [IVIG], IM gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given.
Reported active drug or alcohol or substance abuse/independence or illicit drug use that, in the opinion of the Investigator, would interfere with adherence to study requirements.
Use of H1 antihistamines or beta-blockers within 5 days of dosing Day 1 and Day 45 for Cohorts 1-3 and Day 1 for Cohort 4 (PRN use could be allowed with MM approval).
Use of any prohibited medication within 28 days prior to study entry or planned use during the study period.
Previous exposure to botulinum toxin, receipt of antibodies against botulinum toxin, or previous treatment with equine antitoxin.
Any previous injection or any planned injection within 4 months after enrollment of botulinum toxin for cosmetic reasons, spastic dysphonia, torticollis, or any other reason.
Any illness or condition that in the judgment of the Investigator may affect the safety of the subject or the evaluation of any study endpoint.
Is a study site employee, staff, or close relative as defined.
PIs and Sub-Investigators
Staff who are supervised by the PI, Sub-Investigators
Member of the team conducting this clinical trial
Children, spouse, partners, siblings, and parents of site staff
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
AMR Mobile
Mobile
Alabama
36608
United States
AMR Tempe
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The total duration of this trial was up to approximately 254 days for cohorts 1-3 and up to approximately 134 days for cohort 4. The screening period was up to 14 days for all cohorts, and the treatment/follow-up period was 240 days for cohorts 1-3 and 120 days for cohort 4.
Recruitment Details
A total of 622 participants were enrolled into this trial in the United States between June 2022 and February 2025.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by intramuscular (IM) injection.
FG001
Cohort 1: 50 mg G03-52-01 Lot 2
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 7, 2025
Jan 16, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Single dose of G03-52-01 100 mg or placebo or a repeat dose of G03-52-01 (50mg or 100mg) or placebo on days 1 and 45
Cohorts 1-2 Only: Area Under the Concentration-time Curve to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-t)) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, below limit of quantitation (BLQ) values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the ULQ (upper limit of quantitation) of the assay for analysis.
Day 1 pre-dose, 24 hours post dose, and on Days 8, 15, 45 (prior to dosing), 49, 90, and 120
Cohorts 1-2 Only: Terminal Half-life (t1/2) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
t1/2 was determined after the first dose on Day 1. This value was calculated as t1/2 = ln(2)/ λz where λz is the elimination rate constant.
Only samples up to Day 45 predose were used in these calculations, however the above equation allows a half life greater than the sampling interval.
Day 1 pre-dose, 24 hours post dose, and on Days 8, 15 and 45 (prior to dosing)
Cohorts 1-2 Only: Maximum Observed Concentration (Cmax) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
Day 1 pre-dose, 24 hours post dose, and on Days 8, 15, 45 (prior to dosing), 49, 90, and 120
Cohorts 1-2 Only: Time of Maximum Observed Concentration (Tmax) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
Day 1 pre-dose, 24 hours post dose, and on Days 8, 15, 45 (prior to dosing), 49, 90, and 120
Cohorts 1-2 Only: Number of Participants With Anti-drug Antibodies (ADA) to Each Component of the G03-52-01 Drug Product (DP) at Each Timepoint Tested
The presence of ADA was determined using a validated electrochemiluminescence assay (ECLA) that measured total ADA in serum.
Detected and Not Detected results correspond to samples that were potential positive during screening testing. No Recorded Result (NRR) results correspond to samples that were NRR during screening testing. Percentages are based on n, the number of participants in each treatment group with a non-missing result at each time point for the given analyte.
Day 1 pre-dose and Days 15, 45 (prior to dosing), 60, 90, 120, 150, 180, and 240
Cohort 4 Only: Percentage of Participants With Target Protective NAC Value > 0.02 U/mL (BoNT/A) or > 0.03 U/mL (BoNT/B) at 2 Hours Post Dose
PD samples were tested using the MNA for serotypes A and B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
2 hours post dose on Day 1
Cohort 4 Only: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC(0-inf)) of Each Component of the G03-52-01 DP
PK parameters were measured by enzyme-linked immunosorbent assay (ELISA) or ECLA for each of the monoclonal antibodies (mAb) of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
Cohort 4 Only: AUC(0-t) of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the mAb of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
Cohort 4 Only: Total Body Clearance (CL/F) of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the monoclonal antibodies (mAb) of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
Cohort 4 Only: Cmax of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the mAb of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
Cohort 4 Only: t1/2 of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the monoclonal antibodies (mAb) of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
Cohort 4 Only: Tmax of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the mAb of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
Cohort 4 Only: Volume of Distribution (Vz/F) of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the mAb of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
Cohort 4 Only: AUC(0-t) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
Day 1 pre-dose, 2, 4, 8 and 24 hours post-dose, and on Days 30, 45, and 90
Cohort 4 Only: t1/2 for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
t1/2 was determined after the first dose on Day 1. This value was calculated as t1/2 = ln(2)/ λz where λz is the elimination rate constant.
Only samples up to Day 45 were used in these calculations, however the above equation allows a half life greater than the sampling interval.
Day 1 pre-dose, 2, 4, 8 and 24 hours post-dose, and on Days 30 and 45
Cohort 4 Only: Cmax for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
Day 1 pre-dose, 2, 4, 8 and 24 hours post-dose, and on Days 30, 45, and 90
Cohort 4 Only: Tmax for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
Day 1 pre-dose, 2, 4, 8 and 24 hours post-dose, and on Days 30, 45, and 90
Cohort 4 Only: Number of Participants With ADA to Each Component of the G03-52-01 DP at Each Timepoint Tested
The presence of ADA was determined using a validated ECLA that measured total ADA in serum.
Detected and Not Detected results correspond to samples that were potential positive during screening testing. NRR results correspond to samples that were NRR during screening testing. Percentages are based on n, the number of participants in each treatment group with a non-missing result at each time point for the given analyte.
Day 1 pre-dose and Days 90 and 120
Tempe
Arizona
85281
United States
AMR Fort Myers
Fort Myers
Florida
33912
United States
AMR Miami
Miami
Florida
33134
United States
AMR El Dorado
El Dorado
Kansas
67042
United States
AMR Newton
Newton
Kansas
67114
United States
AMR Wichita West
Wichita
Kansas
67205
United States
AMR Wichita East
Wichita
Kansas
67207
United States
AMR Lexington
Lexington
Kentucky
40509
United States
AMR New Orleans
New Orleans
Louisiana
70119
United States
AMR Kansas City
Kansas City
Missouri
64114
United States
AMR Las Vegas
Las Vegas
Nevada
89119
United States
AMR Norman
Norman
Oklahoma
73069
United States
AMR Knoxville West
Knoxville
Tennessee
37909
United States
AMR Norfolk
Norfolk
Virginia
23502
United States
Participants received a 50 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
FG002
Cohort 2: 100 mg G03-52-01 Lot 1
Participants received a 100 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
FG003
Cohort 2: 100 mg G03-52-01 Lot 2
Participants received a 100 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
FG004
Cohort 3: Placebo
Participants received placebo on Days 1 and 45, administered by IM injection.
FG005
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
FG006
Cohort 4: Placebo
Participants received placebo on Day 1, administered by IM injection.
FG00075 subjects
FG00175 subjects
FG00274 subjects
FG00374 subjects
FG00474 subjects
FG005200 subjects
FG00650 subjects
Dosed with Trial Medication
FG00075 subjects
FG00175 subjects
FG00274 subjects
FG00373 subjects
FG00474 subjects
FG005200 subjects
FG00650 subjects
COMPLETED
FG00064 subjects
FG00164 subjects
FG00259 subjects
FG00361 subjects
FG00461 subjects
FG005190 subjects
FG00647 subjects
NOT COMPLETED
FG00011 subjects
FG00111 subjects
FG00215 subjects
FG00313 subjects
FG00413 subjects
FG00510 subjects
FG0063 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0003 subjects
FG0015 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG0055 subjects
FG0061 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0027 subjects
FG0034 subjects
FG004
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0004 subjects
FG0014 subjects
FG0021 subjects
FG0033 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
BG001
Cohort 1: 50 mg G03-52-01 Lot 2
Participants received a 50 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
BG002
Cohort 2: 100 mg G03-52-01 Lot 1
Participants received a 100 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
BG003
Cohort 2: 100 mg G03-52-01 Lot 2
Participants received a 100 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
BG004
Cohort 3: Placebo
Participants received placebo on Days 1 and 45, administered by IM injection.
BG005
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
BG006
Cohort 4: Placebo
Participants received placebo on Day 1, administered by IM injection.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00075
BG00175
BG00274
BG00374
BG00474
BG005200
BG00650
BG007622
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00042
BG00139
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00013
BG00115
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any unfavourable and unintended sign, symptom, or disease temporarily associated with the use of investigational product (IP), whether or not related to the IP.
A SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a congenital abnormality/birth defect, or caused any persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Clinically significant changes in physical examination, vital signs, and clinical safety laboratory values were included as AEs.
Safety population: All participants who received at least 1 dose of IP. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
Cohorts 1-3: 240 days; Cohort 4: 120 days
ID
Title
Description
OG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
OG001
Cohort 1: 50 mg G03-52-01 Lot 2
Participants received a 50 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
OG002
Cohort 2: 100 mg G03-52-01 Lot 1
Participants received a 100 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
OG003
Cohort 2: 100 mg G03-52-01 Lot 2
Participants received a 100 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
OG004
Cohort 3: Placebo
Participants received placebo on Days 1 and 45, administered by IM injection.
OG005
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
OG006
Cohort 4: Placebo
Participants received placebo on Day 1, administered by IM injection.
Units
Counts
Participants
OG00075
OG00175
OG00274
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG00061
OG00161
OG00261
OG003
Primary
Cohorts 1-2 Only: Percentage of Participants With Target Protective Concentration Neutralizing Antibody Concentration (NAC) Value > 0.02 U/mL (Botulinum Neurotoxin [BoNT]/A) or > 0.03 U/mL (BoNT/B) at Day 45 and Day 90
Pharmacodynamic (PD) samples were tested using the Battelle Mouse Neutralization Assay (MNA) for serotypes A and B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
PD population: The PD population for Cohorts 1-2 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included. Outcome measure data is not available for Cohort 3 because this cohort did not receive the trial medication.
Posted
Number
percentage of participants
Day 45 and Day 90
ID
Title
Description
OG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
OG001
Cohort 1: 50 mg G03-52-01 Lot 2
Participants received a 50 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
Primary
Cohort 4 Only: Percentage of Participants With Target Protective Concentration NAC Value > 0.02 U/mL (BoNT/A) or > 0.03 U/mL (BoNT/B) at 4 and 8 Hours Post Dose
PD samples were tested using the MNA for serotypes A and B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
PD population: The PD population for Cohort 4 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Number
percentage of participants
4 and 8 hours post dose on Day 1
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohorts 1-2 Only: Percentage of Participants With Target Protective Concentration NAC Value > 0.02 U/mL (BoNT/A) or > 0.03 U/mL (BoNT/B) at Day 120
PD samples were tested using the MNA for serotypes A and B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
PD population: The PD population for Cohorts 1-2 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included. Outcome measure data is not available for Cohort 3 because this cohort did not receive the trial medication.
Posted
Number
percentage of participants
Day 120
ID
Title
Description
OG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
OG001
Cohort 1: 50 mg G03-52-01 Lot 2
Participants received a 50 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
OG002
Cohort 2: 100 mg G03-52-01 Lot 1
Secondary
Cohorts 1-2 Only: Area Under the Concentration-time Curve to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-t)) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, below limit of quantitation (BLQ) values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the ULQ (upper limit of quantitation) of the assay for analysis.
PD population: The PD population for Cohorts 1-2 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included. Outcome measure data is not available for Cohort 3 because this cohort did not receive the trial medication.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*U/mL
Day 1 pre-dose, 24 hours post dose, and on Days 8, 15, 45 (prior to dosing), 49, 90, and 120
ID
Title
Description
OG000
Cohort 1: 50 mg G03-52-01 Lot 1
Secondary
Cohorts 1-2 Only: Terminal Half-life (t1/2) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
t1/2 was determined after the first dose on Day 1. This value was calculated as t1/2 = ln(2)/ λz where λz is the elimination rate constant.
Only samples up to Day 45 predose were used in these calculations, however the above equation allows a half life greater than the sampling interval.
PD population: The PD population for Cohorts 1-2 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included. Outcome measure data is not available for Cohort 3 because this cohort did not receive the trial medication.
Posted
Median
Full Range
days
Day 1 pre-dose, 24 hours post dose, and on Days 8, 15 and 45 (prior to dosing)
ID
Title
Description
OG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
OG001
Cohort 1: 50 mg G03-52-01 Lot 2
Participants received a 50 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
Secondary
Cohorts 1-2 Only: Maximum Observed Concentration (Cmax) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
PD population: The PD population for Cohorts 1-2 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included. Outcome measure data is not available for Cohort 3 because this cohort did not receive the trial medication.
Posted
Geometric Mean
Geometric Coefficient of Variation
U/mL
Day 1 pre-dose, 24 hours post dose, and on Days 8, 15, 45 (prior to dosing), 49, 90, and 120
ID
Title
Description
OG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
Secondary
Cohorts 1-2 Only: Time of Maximum Observed Concentration (Tmax) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
PD population: The PD population for Cohorts 1-2 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included. Outcome measure data is not available for Cohort 3 because this cohort did not receive the trial medication.
Posted
Median
Full Range
hours
Day 1 pre-dose, 24 hours post dose, and on Days 8, 15, 45 (prior to dosing), 49, 90, and 120
ID
Title
Description
OG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
Secondary
Cohorts 1-2 Only: Number of Participants With Anti-drug Antibodies (ADA) to Each Component of the G03-52-01 Drug Product (DP) at Each Timepoint Tested
The presence of ADA was determined using a validated electrochemiluminescence assay (ECLA) that measured total ADA in serum.
Detected and Not Detected results correspond to samples that were potential positive during screening testing. No Recorded Result (NRR) results correspond to samples that were NRR during screening testing. Percentages are based on n, the number of participants in each treatment group with a non-missing result at each time point for the given analyte.
Intention to Treat (ITT) population: The ITT population for Cohorts 1-2 consisted of all participants who were randomized. Participants were analyzed according to the treatment group to which they were randomized. Only participants with data available were included. Outcome measure data is not available for Cohort 3 because this cohort did not receive the trial medication.
Posted
Count of Participants
Participants
Day 1 pre-dose and Days 15, 45 (prior to dosing), 60, 90, 120, 150, 180, and 240
ID
Title
Description
OG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
OG001
Cohort 1: 50 mg G03-52-01 Lot 2
Participants received a 50 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
Secondary
Cohort 4 Only: Percentage of Participants With Target Protective NAC Value > 0.02 U/mL (BoNT/A) or > 0.03 U/mL (BoNT/B) at 2 Hours Post Dose
PD samples were tested using the MNA for serotypes A and B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
PD population: The PD population for Cohort 4 included all Safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received.
Posted
Number
percentage of participants
2 hours post dose on Day 1
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohort 4 Only: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC(0-inf)) of Each Component of the G03-52-01 DP
PK parameters were measured by enzyme-linked immunosorbent assay (ELISA) or ECLA for each of the monoclonal antibodies (mAb) of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
PK population: The PK population for Cohort 4 included all safety population participants who had sufficiently evaluable PK results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohort 4 Only: AUC(0-t) of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the mAb of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
PK population: The PK population for Cohort 4 included all safety population participants who had sufficiently evaluable PK results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohort 4 Only: Total Body Clearance (CL/F) of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the monoclonal antibodies (mAb) of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
PK population: The PK population for Cohort 4 included all safety population participants who had sufficiently evaluable PK results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohort 4 Only: Cmax of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the mAb of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
PK population: The PK population for Cohort 4 included all safety population participants who had sufficiently evaluable PK results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohort 4 Only: t1/2 of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the monoclonal antibodies (mAb) of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
PK population: The PK population for Cohort 4 included all safety population participants who had sufficiently evaluable PK results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Median
Full Range
days
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohort 4 Only: Tmax of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the mAb of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
PK population: The PK population for Cohort 4 included all safety population participants who had sufficiently evaluable PK results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Median
Full Range
hours
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohort 4 Only: Volume of Distribution (Vz/F) of Each Component of the G03-52-01 DP
PK parameters were measured by ELISA or ECLA for each of the mAb of G03-52-01, and PK parameters were estimated for each of the six mAbs separately using noncompartmental methods in WinNonlin or a similar software package.
PK population: The PK population for Cohort 4 included all safety population participants who had sufficiently evaluable PK results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Geometric Mean
Geometric Coefficient of Variation
litres
Day 1 pre-dose, 2 hours, 4 hours, 8 hours, 24 hours, 72 hours post dose, and on Days 8, 15, 30, 45, 90, and 120
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Secondary
Cohort 4 Only: AUC(0-t) for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
PD population: The PD population for Cohort 4 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*U/mL
Day 1 pre-dose, 2, 4, 8 and 24 hours post-dose, and on Days 30, 45, and 90
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Secondary
Cohort 4 Only: t1/2 for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
t1/2 was determined after the first dose on Day 1. This value was calculated as t1/2 = ln(2)/ λz where λz is the elimination rate constant.
Only samples up to Day 45 were used in these calculations, however the above equation allows a half life greater than the sampling interval.
PD population: The PD population for Cohort 4 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Median
Full Range
days
Day 1 pre-dose, 2, 4, 8 and 24 hours post-dose, and on Days 30 and 45
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
Secondary
Cohort 4 Only: Cmax for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
PD population: The PD population for Cohort 4 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Geometric Mean
Geometric Coefficient of Variation
U/mL
Day 1 pre-dose, 2, 4, 8 and 24 hours post-dose, and on Days 30, 45, and 90
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Secondary
Cohort 4 Only: Tmax for Serotypes BoNT/A and BoNT/B
PD samples were tested by MNA for serotypes BoNT/A and BoNT/B. The MNA was used to determine the concentration of functional antibodies in a sample capable of neutralizing BoNT (i.e., amount of BoNT/A or BoNT/B toxin neutralization afforded by the combination of antibodies). NAC, as measured by the MNA, is proposed to bridge efficacy between animal models and humans.
If pre-dose concentration was inconclusive, not tested, or missing, or if there were fewer than two measurable concentrations in the participant's profile, the parameters were not determined and the participant was excluded from MNA analysis.
In the calculation of PD parameters, BLQ values were treated as zero prior to the first measurable concentration. After the first measurable concentration, subsequent BLQ values were treated as missing. Values that were above the upper limit of quantitation were set to the upper limit of quantitation of the assay for analysis.
PD population: The PD population for Cohort 4 included all safety population participants who had sufficiently evaluable PD results following dosing. Participants were analyzed according to treatment received. Only participants with data available were included.
Posted
Median
Full Range
hours
Day 1 pre-dose, 2, 4, 8 and 24 hours post-dose, and on Days 30, 45, and 90
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Secondary
Cohort 4 Only: Number of Participants With ADA to Each Component of the G03-52-01 DP at Each Timepoint Tested
The presence of ADA was determined using a validated ECLA that measured total ADA in serum.
Detected and Not Detected results correspond to samples that were potential positive during screening testing. NRR results correspond to samples that were NRR during screening testing. Percentages are based on n, the number of participants in each treatment group with a non-missing result at each time point for the given analyte.
ITT population: The ITT population for Cohort 4 consisted of all participants who were randomized. Participants were analyzed according to the treatment group to which they were randomized. Only participants with data available were included.
Posted
Count of Participants
Participants
Day 1 pre-dose and Days 90 and 120
ID
Title
Description
OG000
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
Units
Counts
Participants
OG000
Time Frame
Cohorts 1-3: 240 days; Cohort 4: 120 days
Description
All-cause mortality, serious AEs and other AEs were reported for all participants who received at least one dose of trial drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: 50 mg G03-52-01 Lot 1
Participants received a 50 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
0
75
2
75
61
75
EG001
Cohort 1: 50 mg G03-52-01 Lot 2
Participants received a 50 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
0
75
0
75
61
75
EG002
Cohort 2: 100 mg G03-52-01 Lot 1
Participants received a 100 mg dose of G03-52-01 (Lot 1) on Days 1 and 45, administered by IM injection.
0
74
1
74
61
74
EG003
Cohort 2: 100 mg G03-52-01 Lot 2
Participants received a 100 mg dose of G03-52-01 (Lot 2) on Days 1 and 45, administered by IM injection.
0
73
0
73
56
73
EG004
Cohort 3: Placebo
Participants received placebo on Days 1 and 45, administered by IM injection.
0
74
0
74
47
74
EG005
Cohort 4: 100 mg G03-52-01
Participants received a 100 mg dose of G03-52-01 on Day 1, administered by IM injection.
0
200
1
200
105
200
EG006
Cohort 4: Placebo
Participants received placebo on Day 1, administered by IM injection.
0
50
0
50
21
50
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastritis
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG0030 events0 affected73 at risk
EG0040 events0 affected74 at risk
EG0051 events1 affected200 at risk
EG0060 events0 affected50 at risk
Localised infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site pain
General disorders
MedDRA Version 25.0
Systematic Assessment
EG00039 events21 affected75 at risk
EG00135 events18 affected75 at risk
EG00242 events23 affected74 at risk
EG00324 events13 affected73 at risk
EG00424 events11 affected74 at risk
EG00577 events50 affected200 at risk
EG0063 events1 affected50 at risk
Fatigue
General disorders
MedDRA Version 25.0
Systematic Assessment
EG00021 events12 affected75 at risk
EG00118 events11 affected75 at risk
EG00217 events12 affected74 at risk
EG003
Injection site erythema
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG0013 events3 affected75 at risk
EG0025 events4 affected74 at risk
EG003
Malaise
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0004 events1 affected75 at risk
EG0012 events2 affected75 at risk
EG0023 events2 affected74 at risk
EG003
Pyrexia
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0011 events1 affected75 at risk
EG0022 events2 affected74 at risk
EG003
Injection site swelling
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0012 events2 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Feeling abnormal
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Medical device pain
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Chest pain
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Influenza like illness
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Injection site hypoaesthesia
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Injection site paraesthesia
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Injection site rash
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0009 events8 affected75 at risk
EG00110 events9 affected75 at risk
EG0024 events4 affected74 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0005 events4 affected75 at risk
EG0014 events3 affected75 at risk
EG0024 events4 affected74 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0004 events3 affected75 at risk
EG0018 events4 affected75 at risk
EG0022 events2 affected74 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0005 events4 affected75 at risk
EG0015 events5 affected75 at risk
EG0024 events4 affected74 at risk
EG003
Blood pressure increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0003 events3 affected75 at risk
EG0011 events1 affected75 at risk
EG0024 events2 affected74 at risk
EG003
Heart rate decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0003 events2 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0013 events3 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Heart rate increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0002 events1 affected75 at risk
EG0011 events1 affected75 at risk
EG0022 events2 affected74 at risk
EG003
Blood potassium increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Blood calcium increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Blood sodium increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
White blood cell count decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Basophil count increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Blood creatine phosphokinase abnormal
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Blood pressure decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Blood pressure systolic decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Blood sodium decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Eosinophil count increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Monocyte count increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Platelet count decreased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Protein urine present
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Red cell distribution width increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
White blood cell count increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG00035 events20 affected75 at risk
EG00123 events16 affected75 at risk
EG00228 events17 affected74 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0009 events7 affected75 at risk
EG0019 events5 affected75 at risk
EG00212 events10 affected74 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG00014 events8 affected75 at risk
EG0016 events6 affected75 at risk
EG0028 events6 affected74 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0003 events3 affected75 at risk
EG0012 events2 affected75 at risk
EG0025 events4 affected74 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0011 events1 affected75 at risk
EG0022 events2 affected74 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0012 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG00111 events5 affected75 at risk
EG0026 events4 affected74 at risk
EG003
Diastolic hypertension
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0012 events1 affected75 at risk
EG0025 events3 affected74 at risk
EG003
Systolic hypertension
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0011 events1 affected75 at risk
EG0024 events4 affected74 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0004 events3 affected75 at risk
EG0010 events0 affected75 at risk
EG0022 events2 affected74 at risk
EG003
Haematoma
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG00011 events9 affected75 at risk
EG00114 events11 affected75 at risk
EG0028 events7 affected74 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Femoroacetabular impingement
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Joint noise
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
COVID-19
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG0013 events3 affected75 at risk
EG0025 events5 affected74 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0003 events2 affected75 at risk
EG0014 events4 affected75 at risk
EG0023 events2 affected74 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0012 events1 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Fungal infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Gingivitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Otitis media
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Viral infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0022 events2 affected74 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA Version 25.0
Systematic Assessment
EG0004 events3 affected75 at risk
EG0015 events3 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0011 events1 affected75 at risk
EG0023 events3 affected74 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Mitral valve prolapse
Cardiac disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0022 events2 affected74 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Iliotibial band syndrome
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Periorbital haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Superficial injury of eye
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0003 events2 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0002 events2 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0012 events2 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Major depression
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Panic disorder
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Terminal insomnia
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 25.0
Systematic Assessment
EG0003 events3 affected75 at risk
EG0013 events3 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0012 events1 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Mammary duct ectasia
Reproductive system and breast disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 events1 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Goitre
Endocrine disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Hypogonadism male
Endocrine disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Thyroid cyst
Endocrine disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0012 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected74 at risk
EG003
Eye irritation
Eye disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 events0 affected75 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected74 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)