Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019085-82 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport RU 20 U | Experimental |
| |
| Dysport RU 50 U | Experimental |
| |
| Dysport RU 75 U | Experimental |
| |
| Dysport (Azzalure) 50 U | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | I.M. (in the muscle) injection on day 1 (single treatment cycle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Treatment Emergent Adverse Event (TEAE) | Up to Day 113 (±3 days) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ipsen Study Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private practice | Bordeaux | France | ||||
| Private practice |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Not provided
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
A total of 178 patients were screened. 2 patient did not meet the entry criteria. 176 patients were randomized.Patients were randomized into 5 groups.
Study was performed as a multicentre study at eight investigational sites in France and Germany. Date of first enrolment: 30-Mar-2011 and Date of last completed: 27-Sep-2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| FG001 | Dysport NG 20 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) Ready to Use (RU) |
| FG002 | Dysport NG 50 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| FG003 | Dysport NG 75 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| FG004 | Dysport 50 U | Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| BG001 | Dysport NG 20 U |
| 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 Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2. | Intent-to-Treat Population: The intent-to-treat (ITT) population included all randomised subjects who received study treatment, regardless of the actual amount injected. N'=number of subjects with assessment | Posted | Number | percentage of subjects | Day 29 |
|
Up to Day 113 (±3 days)
Not provided
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 | Placebo | Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Botulinum toxin type A | Biological | I.M. on day 1 (single treatment cycle) |
|
|
| Placebo | Drug | I.M. on day 1 (single treatment cycle) |
|
| Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | Days 8, 15, 57, 85 and 113 |
| Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | Days 8, 15, 57, 85 and 113 |
| Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Days 8, 15, 57, 85 and 113 |
| Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2. | Days 8, 15, 29, 57, 85 and 113 |
| Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2. | Day 113 |
| Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment | A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment | Days 8, 15, 29, 57, 85 and 113 |
| Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment | A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment. | Days 8, 15, 29, 57, 85 and 113 |
| Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment | A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment. | Days 8, 15, 29, 57, 85 and 113 |
| Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | Days 8, 15, 29, 57, 85 and 113 |
| Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | Days 8, 15, 29, 57, 85 and 113 |
| Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | Days 8, 15, 29, 57, 85 and 113 |
| Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity) | Day 29 |
| Cannes |
| France |
| Private practice | Juan-les-Pins | France |
| Private practice | Paris | France |
| Charité hospital | Berlin | Germany |
| Private clinic | Dresden | Germany |
| Private clinic | Munich | Germany |
| Private clinic | Starnberg | Germany |
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| BG002 | Dysport NG 50 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| BG003 | Dysport NG 75 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| BG004 | Dysport 50 U | Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| OG001 | Dysport NG 20 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| OG002 | Dysport NG 50 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
| OG003 | Dysport NG 75 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) |
|
|
|
| Secondary | Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2. | ITT Population; Day 29 (N'=34,36,35,33,35); N'= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit | Posted | Number | percentage of subjects | Day 29 |
|
|
|
| Secondary | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ITT Population; N'=number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit | Posted | Number | percentage of subjects | Days 8, 15, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | ITT Population; N'= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit | Posted | Number | percentage of subjects | Days 8, 15, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | ITT Population; N'= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit | Posted | Number | percentage of subjects | Days 8, 15, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2. | ITT Population; N'= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit; | Posted | Number | percentage of subjects | Days 8, 15, 29, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2. | ITT Population; N'=number of responders at Day 29 | Posted | Number | percentage of subjects | Day 113 |
|
|
|
| Secondary | Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment | A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment | ITT Population; N'= number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit | Posted | Number | percentage of subjects | Days 8, 15, 29, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment | A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment. | ITT Population; N'= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit | Posted | Number | percentage of subjects | Days 8, 15, 29, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment | A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment. | ITT Population; N'= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit | Posted | Number | percentage of subjects | Days 8, 15, 29, 57, 85 and 113 |
|
|
|
| Other Pre-specified | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Treatment Emergent Adverse Event (TEAE) | Safety Population: The safety population included all randomised subjects who received study treatment, regardless of the actual amount injected | Posted | Number | participants | Up to Day 113 (±3 days) |
|
|
|
| Secondary | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ITT Population; N'=number of subjects with assessment | Posted | Number | percentage of subjects | Days 8, 15, 29, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | ITT Population; N'=number of subjects with assessment | Posted | Number | percentage of subjects | Days 8, 15, 29, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ITT Population; N'=number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit | Posted | Number | percentage of subjects | Days 8, 15, 29, 57, 85 and 113 |
|
|
|
| Secondary | Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity) | ITT Population; N'=number of subjects with an assessment at Day 29 | Posted | Number | percentage of subjects | Day 29 |
|
|
|
| 0 |
| 35 |
| 12 |
| 35 |
| EG001 | Dysport NG 20 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) | 1 | 36 | 14 | 36 |
| EG002 | Dysport NG 50 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) | 0 | 35 | 10 | 35 |
| EG003 | Dysport NG 75 U | Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) | 0 | 35 | 11 | 35 |
| EG004 | Dysport 50 U | Botulinum type A toxin ((Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) | 0 | 35 | 10 | 35 |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Eczema infected | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site anaesthesia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Laparoscopy | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
Not provided
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| ILA: Day 15 (N'=33,36,35,35) |
|
| ILA: Day 57 (N'=33,35,34,34) |
|
| ILA: Day 85 (N'=34,33,34,32) |
|
| ILA: Day 113 (N'=34,36,35,34) |
|
| SSA: Day 15 (N'=33,36,35,35) |
|
| SSA: Day 57 (N'=34,35,34,34) |
|
| SSA: Day 85 (N'=34,35,34,32) |
|
| SSA: Day 113 (N'=34,36,35,34) |
|
| Day 15 (N'=34,36,35,35,34) |
|
| Day 57 (N'=34,35,34,34,34) |
|
| Day 85 (N'=34,33,34,32,34) |
|
| Day 113 (N'=34,36,35,34,35) |
|
| ILA: Day 15 (N'=18,17,13,14) |
|
| ILA: Day 29 (N'=18,17,13,14) |
|
| ILA: Day 57 (N'=17,16,13,14) |
|
| ILA: Day 85 (N'=18,17,12,14) |
|
| ILA: Day 113 (N'=18,17,13,14) |
|
| SSA: Day 29 (N'=1,33,30,27,29) |
|
| ILA: Day 15 (N'=33,36,35,35,34) |
|
| ILA: Day 29 (N'=34,36,35,33,35) |
|
| ILA: Day 57 (N'=33,35,34,34,34) |
|
| ILA: Day 85 (N'=34,33,34,32,34) |
|
| ILA: Day 113 (N'=34,36,35,34,35) |
|
| ILA: Day 15 (N'=18,17,13,14,18) |
|
| ILA: Day 29 (N'=18,17,13,14,19) |
|
| ILA: Day 57 (N'=17,16,13,14,19) |
|
| ILA: Day 85 (N'=18,17,12,14,19) |
|
| ILA: Day 113 (N'=18,17,13,14,19) |
|
| SSA: Day 15 (N'=33,36,35,35,34) |
|
| SSA: Day 29 (N'=34,36,35,33,35) |
|
| SSA: Day 57 (N'=34,35,34,34,34) |
|
| SSA: Day 85 (N'=34,35,34,32,34) |
|
| SSA: Day 113 (N'=34,36,35,34,35) |
|
| Severe TEAE |
|
| Related TEAE |
|
| Related and severe TEAE |
|
| TEAE leading to withdrawal |
|
| TEAE leading to death |
|
| Serious Adverse Event (SAE) |
|
| ILA: Day 15 (N'=36,35,35,34) |
|
| ILA: Day 29 (N'=36,35,33,35) |
|
| ILA: Day 57 (N'=35,34,34,34) |
|
| ILA: Day 85 (N'=33,34,32,34) |
|
| ILA: Day 113 (N'=36,35,34,35) |
|
| SSA: Day 15 (N'=36,35,35,34) |
|
| SSA: Day 29 (N'=36,35,33,35) |
|
| SSA: Day 57 (N'=35,34,34,34) |
|
| SSA: Day 85 (N'=35,34,32,34) |
|
| SSA: Day 113 (N'=36,35,34,35) |
|
| ILA: Day 15 (N'=17,13,14,18) |
|
| ILA: Day 29 (N'=17,13,14,19) |
|
| ILA: Day 57 (N'=16,13,14,19) |
|
| ILA: Day 85 (N'=17,12,14,19) |
|
| ILA: Day 113 (N'=17,13,14,19) |
|