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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004384-31 | EudraCT Number |
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To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT10109L | Experimental | MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. |
|
| Placebo | Placebo Comparator | Placebo will be injected into the GL: initial double-blind treatment on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT10109L | Drug | MT10109L will be injected into the GL. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30 | The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe |
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Inclusion Criteria
• Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| SangMi Park | Medytox Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigate MD | Scottsdale | Arizona | 85255 | United States | ||
| Art of Skin MD |
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234 met the inclusion/exclusion criteria and were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/MT10109L | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments. |
| FG001 | MT10109L/MT10109L | MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
234 participants were included in the Intent To Treat (ITT) population (80 participants in the placebo group and 154 participants in the MT10109L group).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/MT10109L | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments. |
| BG001 | MT10109L/MT10109L |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30 | The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline. | All primary and secondary efficacy analyses endpoints were carried out using the Intent-To-Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint. Analyses of the secondary efficacy variables were performed using observed data. | Posted | Count of Participants | Participants | Day 30 |
The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
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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 | Placebo | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part post day 180, up to 2 open-label study interventions during the retreatment period. Placebo participants were allowed to enter open-label phase for retreatment but the TEAEs with onset date after the retreatment were not counted here. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA, Version 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA, Version 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Young Ryu | Medytox Inc. | +82-2-6901-5424 | aab005@medytox.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 | Sep 30, 2020 | Jul 17, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2020 | Jul 17, 2023 | SAP_003.pdf |
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| Placebo | Drug | Placebo will be injected into the GL. |
|
| Day 30 |
| The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS) | The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS). | Day 1 (first treatment) to Day 180 |
| The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL) | The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied. | Day 60 |
| The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS). | The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. | Day 30 |
| Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration | This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). |
| Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP) | Change from baseline at study exit. | Baseline to Study exit (Day 360 or early exit) |
| Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP) | Change from baseline at study exit. | Baseline to Study exit (Day 360 or early exit) |
| Mean Change From Baseline in Vital Signs - Pulse Rate | Change from baseline at study exit. | Baseline to Study exit (Day 360 or early exit) |
| Mean Change From Baseline in Vital Signs - Respiratory Rate | Change from baseline at study exit. | Baseline to Study exit (Day 360 or early exit) |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate | Change from baseline at study exit. | Baseline to Study Exit (Day 360 or early exit) |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | Change from baseline at study exit. | Baseline to Study Exit (Day 360 or early exit) |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | Change from baseline at study exit. | Baseline to Study Exit (Day 360 or early exit) |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | Change from baseline at study exit. | Baseline to Study Exit (Day 360 or early exit) |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | Change from baseline at study exit. | Baseline to Study Exit (Day 360 or early exit) |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | Change from baseline at study exit. | Baseline to Study Exit (Day 360 or early exit) |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | Change from baseline at study exit. | Baseline to Study Exit (Day 360 or early exit) |
| Number of Participants With Binding and Neutralizing Antibodies | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. | Up to Study Exit (Day 360 or early exit) |
| Solana Beach |
| California |
| 92075 |
| United States |
| Weinkle Dermatology | Bradenton | Florida | 34209 | United States |
| Etre, Cosmetic Dermatology and Laser Center | New Orleans | Louisiana | 70130 | United States |
| Dermatology and Laser Surgery Center of New York | New York | New York | 10028 | United States |
| SkinSearch of Rochester, Inc. | Rochester | New York | 14623 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| Aventiv Research, Inc. | Dublin | Ohio | 43016 | United States |
| Westlake Dermatology & Cosmetic Surgery | Austin | Texas | 78746 | United States |
| Centre de la Fontaine | Loverval | Hainaut | 6280 | Belgium |
| Medical Skin Care | Sint-Truiden | Limburg | 3800 | Belgium |
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| CHU Liege | Liège | 4000 | Belgium |
| Kazan State Medical University | Kazan' | Tatarstan Republic | 420105 | Russia |
| Medical Centre Capital-Zdorovie | Moscow | 109369 | Russia |
| Lost to Follow-up |
|
| Pregnancy |
|
| Physician Decision |
|
| Protocol Violation |
|
| Other (Early termination, COVID, Family issue) |
|
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Placebo/MT10109L | Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments. |
| OG001 | MT10109L/MT10109L | MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. |
|
|
| Secondary | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe | All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| Secondary | The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS) | The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS). | The analysis population for this outcome includes the participants who achieved a rating of ≥ 2-gradeimprovement from baseline in GL severity at maximum frown at Day 30 of double-blind period according to investigator assessments using the Facial Wrinkle Scale (FWS). This corresponds to the responders for Outcome 2. Note: Analyses of the secondary efficacy variables were performed using observed data. | Posted | Median | 95% Confidence Interval | Days | Day 1 (first treatment) to Day 180 |
|
|
|
| Secondary | The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL) | The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied. | All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which wasdefined as all participants who were randomized. Analyses of the secondary efficacy variables wereperformed using observed data | Posted | Count of Participants | Participants | Day 60 |
|
|
|
| Secondary | The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS). | The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. | All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| Secondary | Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration | This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. | All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow. | Posted | Count of Participants | Participants | The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit). |
|
|
|
| Secondary | Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP) | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | mmHg | Baseline to Study exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP) | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | mmHg | Baseline to Study exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Vital Signs - Pulse Rate | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | beats/min | Baseline to Study exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Vital Signs - Respiratory Rate | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | breaths/min | Baseline to Study exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | beats/min | Baseline to Study Exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Study Exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Study Exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Study Exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Study Exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Study Exit (Day 360 or early exit) |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | Change from baseline at study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Study Exit (Day 360 or early exit) |
|
|
|
| Secondary | Number of Participants With Binding and Neutralizing Antibodies | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. | All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Up to Study Exit (Day 360 or early exit) |
|
|
|
| 0 |
| 80 |
| 3 |
| 80 |
| 8 |
| 80 |
| EG001 | MT10109L | MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo participants who experienced TEAE after receiving MT10109L during open-label phase were counted here. | 0 | 223 | 5 | 223 | 32 | 223 |
| Pneumonia | Infections and infestations | MedDRA, Version 23.1 | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA, Version 23.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 23.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA, Version 23.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA, Version 23.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA, Version 23.1 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 23.1 | Systematic Assessment |
|
| Breast Cancer Stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 23.1 | Systematic Assessment |
|
| Malignant Melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 23.1 | Systematic Assessment |
|
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA, Version 23.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA, Version 23.1 | Systematic Assessment |
|
General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results.