Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe glabellar lines (GL).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Placebo | Placebo Comparator | Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1. |
|
| Cohort 1: AGN-151586 | Experimental | Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1. |
|
| Cohort 2: Placebo | Placebo Comparator | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2. |
|
| Cohort 2: AGN-151586 | Experimental | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
|
| Cohort 3: Placebo | Placebo Comparator | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3. |
|
| Cohort 3: AGN-151586 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-151586 | Drug | AGN-151586 solution for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. | Baseline (Day 1) through Day 7 |
| Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention. | From first dose of study drug until the end of study (up to 42 days) |
| Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP. | From first dose of study drug until the end of study (up to 42 days) |
| Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP. |
Not provided
Not provided
Inclusion Criteria:
-Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (at least 10 weeks after study intervention).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clinical Research /ID# 237798 | Fremont | California | 94538 | United States | ||
| Ava T. Shamban MD - Santa Monica. /ID# 235353 |
Not provided
| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance | View source |
Not provided
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
A total of 198 participants with moderate to severe glabellar lines (GL) were enrolled and randomized in a 3:1 ratio to receive AGN-151586 in 5 sequential AGN-151586 dose rising cohorts or Placebo in each of the 5 cohorts.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Placebo | Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1. |
| FG001 | Cohort 1: AGN-151586 | Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1. |
| FG002 | Cohort 2: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2. |
| FG003 | Cohort 2: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| FG004 | Cohort 3: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3. |
| FG005 | Cohort 3: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| FG006 | Cohort 4: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4. |
| FG007 | Cohort 4: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| FG008 | Cohort 5: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5. |
| FG009 | Cohort 5: AGN-151586 | Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified intent-to-treat (mITT) population included all randomized participants who received the study intervention and who had at least one postintervention investigator-rated facial wrinkle scale with photonumeric guide (FWS) measurement at maximum frown.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Placebo | Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1. |
| BG001 | Cohort 1: AGN-151586 |
| 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 | Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7 | Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. | mITT population included all randomized participants who received the study intervention and who had at least one postintervention investigator-rated FWS measurement at maximum frown. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) through Day 7 |
|
All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
Not provided
| 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: Placebo | Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 1-800-633-9110 | abbvieclinicaltrials@abbvie.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2021 | Jul 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2020 | Jul 10, 2023 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
|
| Cohort 4: Placebo | Placebo Comparator | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4. |
|
| Cohort 4: AGN-151586 | Experimental | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
|
| Cohort 5: Placebo | Placebo Comparator | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5. |
|
| Cohort 5: AGN-151586 | Experimental | Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1. |
|
| Placebo | Drug | Placebo solution for injection. |
|
| From first dose of study drug until the end of study (up to 42 days) |
| Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: > 500 msec or change from baseline value: increase of > 60 msec; QTcF observed value: > 500 msec or change from baseline value: increase of > 60 msec. | From first dose of study drug until the end of study (up to 42 days) |
| Number of Participants With Anti-drug Antibodies (ADAs) | Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies. | Up to Day 42 |
| Santa Monica |
| California |
| 90404-2208 |
| United States |
| Skin and Cancer Associates, LLP /ID# 236231 | Miami | Florida | 33137-3254 | United States |
| Laser and Skin Surgery Center of Indiana /ID# 236588 | Indianapolis | Indiana | 46260-2386 | United States |
| Wilmington Dermatology Center /ID# 237055 | Wilmington | North Carolina | 28403 | United States |
| Kgl, Llc /Id# 234798 | Newtown Square | Pennsylvania | 19073-2228 | United States |
| DermResearch Inc. /ID# 234483 | Austin | Texas | 78759 | United States |
| Austin Institute for Clinical Research at SBA Dermatology /ID# 236646 | Houston | Texas | 77056-4129 | United States |
| Austin Institute for Clinical Research /ID# 237135 | Pflugerville | Texas | 78660 | United States |
| Lost to Follow-up |
|
| COVID-19-related reasons |
|
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
| BG002 | Cohort 2: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2. |
| BG003 | Cohort 2: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| BG004 | Cohort 3: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3. |
| BG005 | Cohort 3: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| BG006 | Cohort 4: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4. |
| BG007 | Cohort 4: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| BG008 | Cohort 5: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5. |
| BG009 | Cohort 5: AGN-151586 | Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1. |
| BG010 | 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 |
|
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1. |
| OG001 | Cohort 1: AGN-151586 | Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1. |
| OG002 | Cohort 2: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2. |
| OG003 | Cohort 2: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| OG004 | Cohort 3: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3. |
| OG005 | Cohort 3: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| OG006 | Cohort 4: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4. |
| OG007 | Cohort 4: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. |
| OG008 | Cohort 5: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5. |
| OG009 | Cohort 5: AGN-151586 | Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1. |
|
|
|
| Primary | Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention. | Safety population included all participants who received study intervention. | Posted | Count of Participants | Participants | From first dose of study drug until the end of study (up to 42 days) |
|
|
|
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention | Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP. | Safety population included all participants who received study intervention. | Posted | Count of Participants | Participants | From first dose of study drug until the end of study (up to 42 days) |
|
|
|
| Primary | Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention | Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP. | Safety population included all participants who received study intervention. | Posted | Count of Participants | Participants | From first dose of study drug until the end of study (up to 42 days) |
|
|
|
| Primary | Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention | Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: > 500 msec or change from baseline value: increase of > 60 msec; QTcF observed value: > 500 msec or change from baseline value: increase of > 60 msec. | Safety population included all participants who received study intervention. | Posted | Count of Participants | Participants | From first dose of study drug until the end of study (up to 42 days) |
|
|
|
| Primary | Number of Participants With Anti-drug Antibodies (ADAs) | Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies. | Safety population included all participants who received study intervention. Overall number of participants analyzed are the number of participants available for analyses. Number analyzed indicates the number of participants with data available for analysis for the below categories. | Posted | Count of Participants | Participants | Up to Day 42 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Cohort 1: AGN-151586 | Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1. | 0 | 32 | 0 | 32 | 15 | 32 |
| EG002 | Cohort 2: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG003 | Cohort 2: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. | 0 | 28 | 0 | 28 | 10 | 28 |
| EG004 | Cohort 3: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3. | 0 | 11 | 0 | 11 | 7 | 11 |
| EG005 | Cohort 3: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. | 0 | 27 | 0 | 27 | 9 | 27 |
| EG006 | Cohort 4: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4. | 0 | 10 | 0 | 10 | 3 | 10 |
| EG007 | Cohort 4: AGN-151586 | Participants received AGN-151586, IM injections in the glabellar complex on Day 1. | 0 | 30 | 0 | 30 | 9 | 30 |
| EG008 | Cohort 5: Placebo | Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG009 | Cohort 5: AGN-151586 | Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1. | 0 | 31 | 0 | 31 | 12 | 31 |
| Facial pain | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pharyngeal hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Breast induration | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
|
| Neutralizing Antibodies |
|
|