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This is a Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate the Relative Bioavailability of CVN424 Suspension and Tablet Formulations in Healthy Volunteers Under Fasted and Fed Conditions.
32 healthy male or female participants will be enrolled in 1 of 6 sequences (designated as 1 through 6, respectively) in an ascending fashion. Sequences 1, 3, 4, and 5 will have 5 participants each, and Sequences 2 and 6 will have 6 participants each.
Each sequence will proceed through the three cross-overs (suspension-fasted, tablet-fed, and tablet-fasted) according to the schematic, with dosing to occur on Days 1 of Periods 1, 2, and 3. Participants in the fasted portion of each sequence will be dosed under overnight fasted conditions and will remain fasted for 4 hours post-dose. Water consumption is permitted as desired except for 1 hour before and after administration of the Study Drug.
To assess the effect of food on CVN424 bioavailability in tablet formulation, the single dose will be administered after ingestion of a standardized high-fat, high-calorie meal according to FDA Guidance for Industry (Food-effect bioavailability and fed bioequivalence studies, Jun 2022).
Participants for all sequences will be admitted to the study unit 1 day prior to dosing and remain in the unit for safety and pharmacokinetics (PK) assessments through 96 hours post-dose. The total confinement period will be 5 nights for each period unless extended at the discretion of the Investigator, e.g., for monitoring and/or management of adverse events (AEs).
Once 96-hour post-dose PK has been collected, participants will be discharged from the unit for the remainder of the washout period and return the day prior for their next scheduled dosing period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspension (fasted) | Active Comparator | 150 milligrams (mg) of CVN424 administered in a single dose of suspension formulation. |
|
| Tablet (fed) | Active Comparator | 150 milligrams (mg) tablet of CVN424 administered in a single dose after ingestion of a standardized high-fat, high-calorie meal according to FDA Guidance for Industry (Food-effect bioavailability and fed bioequivalence studies, Jun 2022). |
|
| Tablet (fasted) | Active Comparator | 150 milligrams (mg) tablet of CVN424 administered in a single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVN424 | Drug | 150 mg of either tablet or suspension formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measured Non Zero Concentration (AUC0-t) of CVN424 Suspension Fasted and Tablet Fasted | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| Area Under the Plasma Concentration Time Curve From Time 0 to 96 Hours (AUC 0-96h) of CVN424 Suspension Fasted and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) of CVN424 Suspension Fasted and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| Time to Reach Cmax (Tmax) of CVN424 Suspension and Tablet | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| Time Taken for Drug to Appear in Systemic Circulation Following Administration (Tlag) of CVN424 Suspension and Tablet | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| AUC(0-96 Hrs) of CVN424 Tablet Fed and Tablet Fasted |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Martin Bexon, MD | Cerevance Beta, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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A total of 32 participants entered the study and were randomized per protocol to 6 treatment sequences.
This was an Open-label, single oral dose, 3-way cross-over trial that evaluated the relative bioavailability of CVN424 suspension and tablet formulations and also included the assessment of the effect of food on the tablet formulation in healthy adult volunteers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence ABC | Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 3. There was a washout period of 14 days between each treatment period. |
| FG001 | Treatment Sequence ACB | Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period. |
| FG002 | Treatment Sequence BAC | Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 2 and Treatment C: CVN424 150 mg Tablet (fed) in period 3. There was a washout period of 14 days between each treatment period. |
| FG003 | Treatment Sequence BCA | Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 3. There was a washout period of 14 days between each treatment period. |
| FG004 | Treatment Sequence CAB | Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment A: CVN424 150 mg suspension (fasted) in period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period. |
| FG005 | Treatment Sequence CBA | Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in period 3. There was a washout period of 14 days between each treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Dosing 1 (Day 1) |
| |||||||||||||
| Washout Period (7 Days) |
| |||||||||||||
| Period 2: Dosing 2 (Day 1) |
| |||||||||||||
| Washout Period (7 Days) |
| |||||||||||||
| Period 3: Dosing 3 (Day 1) |
|
Safety Analysis Set consisted of all participants who were enrolled and received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence ABC | Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 3. There was a washout period of 14 days between each treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measured Non Zero Concentration (AUC0-t) of CVN424 Suspension Fasted and Tablet Fasted | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set consists of all participants who received study drug and had at least 1 measurable plasma concentration. Only those participants with data available at specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: CVN424 150 mg Suspension (Fasted) | Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Charles, Executive Director Regulatory Affairs | Cerevance | (408) 220-5722 | michelle.charles@cerevance.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2022 | Mar 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2022 | Mar 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. |
| Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| Cmax of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| Tmax of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| Tlag of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
| Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) | An adverse event is any untoward medical occurrence in a clinical research study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. | Up to Day 35 |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Treatment Sequence ACB | Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period. |
| BG002 | Treatment Sequence BAC | Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 2 and Treatment C: CVN424 150 mg Tablet (fed) in period 3. There was a washout period of 14 days between each treatment period. |
| BG003 | Treatment Sequence BCA | Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 3. There was a washout period of 14 days between each treatment period. |
| BG004 | Treatment Sequence CAB | Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment A: CVN424 150 mg suspension (fasted) in period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period. |
| BG005 | Treatment Sequence CBA | Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in period 3. There was a washout period of 14 days between each treatment period. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Treatment B: CVN424 150 mg Tablet (Fasted) | Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition. |
|
|
|
| Primary | Area Under the Plasma Concentration Time Curve From Time 0 to 96 Hours (AUC 0-96h) of CVN424 Suspension Fasted and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of CVN424 Suspension Fasted and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Primary | Time to Reach Cmax (Tmax) of CVN424 Suspension and Tablet | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Median | Full Range | hours | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Primary | Time Taken for Drug to Appear in Systemic Circulation Following Administration (Tlag) of CVN424 Suspension and Tablet | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Median | Full Range | hours | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Secondary | AUC(0-t) of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Secondary | AUC(0-96 Hrs) of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Secondary | Cmax of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Secondary | Tmax of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Median | Full Range | hours | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Secondary | Tlag of CVN424 Tablet Fed and Tablet Fasted | Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis. | PK Analysis Set. Only those participants with data available at specified timepoints have been presented. | Posted | Median | Full Range | hours | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose |
|
|
|
|
| Secondary | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) | An adverse event is any untoward medical occurrence in a clinical research study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. | Safety Analysis Set. | Posted | Count of Participants | Participants | Up to Day 35 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 8 |
| 30 |
| EG001 | Treatment B: CVN424 150 mg Tablet (Fasted) | Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition. | 0 | 30 | 0 | 30 | 11 | 30 |
| EG002 | Treatment C: CVN424 150 mg Tablet (Fed) | Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition. | 0 | 32 | 0 | 32 | 11 | 32 |
| Asthenopia | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Nasal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Median Difference (Final Values) |
| 2.78 |
| 2-Sided |
| 90 |
| 2.4475 |
| 3.0035 |
| Other |
| Median Difference (Final Values) |
| 0.25 |
| 2-Sided |
| 90 |
| 0.0000 |
| 0.2510 |
| Other |