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| Name | Class |
|---|---|
| Innovaderm Research Inc. | OTHER |
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The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.
Neutrophilic dermatoses are a spectrum of inflammatory disorders characterized by skin lesions resulting from a neutrophil-rich inflammatory infiltrate in the absence of infection. Pyoderma gangrenosum is associated with a neutrophilic leukocytosis, which is likely to be triggered by C5a. This study is set up based on the hypothesis that vilobelimab might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vilobelimab 800 mg Q2W | Experimental | Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W. |
|
| vilobelimab 1600 mg Q2W | Experimental | Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W. |
|
| vilobelimab 2400 mg Q2W | Experimental | Dose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 3 (N=7) received vilobelimab 2400 mg every Q2W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vilobelimab | Drug | IV infusions of vilobelimab diluted in sodium chloride. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Number of patients with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, and adverse events of special interest (AESIs) TEAEs are defined as adverse events that start at or after the first administration of study drug. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study drug. AESIs are defined as infusion-related reactions, including acute and delayed hypersensitivity and anaphylactic reactions during or after infusion; Meningitis; Meningococcal septicaemia; Invasive infection. As adverse events will be reported in details in the safety section, no separate reporting on System Organ Class (SOC) or Preferred Term (PT) level etc. is done here. | From treatment start until end of study (including observational visits), an average of 249 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | Efficacy endpoint: Proportion of patients with a clinical response, defined as Physician's Global Assessment (PGA) score ≤3 of target ulcer at Visit V4, V6, V10 and V16 (End of Treatment [EOT]) (SAF). PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse |
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Inclusion Criteria:
In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:
History of
Clinical examination (or photographic evidence) of
Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Niels C. Riedemann, M.D., Ph.D. | InflaRx GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InflaRx Site #07 | Sacramento | California | 95816 | United States | ||
| InflaRx Site #08 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vilobelimab 800 mg Q2W | Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W. |
| FG001 | Vilobelimab 1600 mg Q2W | Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W. |
| FG002 | Vilobelimab 2400 mg Q2W | Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vilobelimab 800 mg Q2W | Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W. |
| BG001 | Vilobelimab 1600 mg Q2W |
| 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 | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Number of patients with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, and adverse events of special interest (AESIs) TEAEs are defined as adverse events that start at or after the first administration of study drug. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study drug. AESIs are defined as infusion-related reactions, including acute and delayed hypersensitivity and anaphylactic reactions during or after infusion; Meningitis; Meningococcal septicaemia; Invasive infection. As adverse events will be reported in details in the safety section, no separate reporting on System Organ Class (SOC) or Preferred Term (PT) level etc. is done here. | Safety set | Posted | Count of Participants | Participants | From treatment start until end of study (including observational visits), an average of 249 days |
|
From treatment start until end of study (including observational visits), an average of 249 days
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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 | Vilobelimab 800 mg Q2W | Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocarditis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Niels C. Riedemann | InflaRx | +49-(0) 3641-508 180 | niels.riedemann@inflarx.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2020 | Sep 4, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 14, 2020 | Sep 4, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D017511 | Pyoderma Gangrenosum |
| ID | Term |
|---|---|
| D011711 | Pyoderma |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
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| ID | Term |
|---|---|
| C000706656 | vilobelimab |
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IV infusions of vilobelimab diluted in sodium chloride
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|
| From treatment start until V16 (Day 189) |
| Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] | Efficacy endpoint: Kaplan-Meier analysis of time to first clinical remission (complete closure of target ulcer) defined as PGA score of ≤ 1, PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse | From treatment start until end of study (including observational visits), an average of 249 days |
| Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | Efficacy endpoint: Percentage change in wound area [percent change] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16. | From treatment start until V16 (Day 189) |
| Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | Efficacy endpoint: Percentage change in wound volume [percent change] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16. | From treatment start until V16 (Day 189) |
| Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | Efficacy endpoint: Rate of change per day in area of target ulcer [mm²/day] between Visits V1 and V16 (photographic assessment) | From treatment start until V16 (Day 189) |
| Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | Efficacy endpoint: Number of patients with a decrease in area of target ulcer of ≥ 50% by photographic assessment at Visit V16 (EOT) compared to Baseline | From treatment start until V16 (Day 189) |
| Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | Efficacy endpoint: Number of patients with a decrease in area of target ulcer of 100% at Visit V16 (EOT) compared to Baseline (remission) (photographic assessment) | From treatment start until V16 (Day 189) |
| Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | Efficacy endpoint: Degree of erythema of the target ulcer at Visit V4, V6, V10 and V16 (EOT) (investigator assessment) | From treatment start until V16 (Day 189) |
| Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | Efficacy endpoint: Border elevation of the target ulcer at visits V4, V6, V10 and V16 (EOT) (investigator assessment) | From treatment start until V16 (Day 189) |
| Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | Efficacy endpoint: Percentage change from Baseline in pain assessed by Numeric Rating Scale (NRS) [percent change] at visits V4, V6, V10 and V16 (EOT) Mean (SD) The NRS is an 11-point scale (from 0 represent no pain to 10 representing the worst pain the subject can imagine). | From treatment start until V16 (Day 189) |
| Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | Efficacy endpoint: Percentage change from Baseline in Dermatology Life Quality Index (DLQI) [percent change] at visits V4, V6, V10, and V16 (EOT) The DLQI comprises 10 questions with single scores 0 (No effect on patient's life) to 3 (large effect on patient's life). The DLQI total score is calculated by summing up the score of each question resulting in a minimum of 0 (best) and a maximum of 30 (worst). | From treatment start until V16 (Day 189) |
| Miami |
| Florida |
| 33125 |
| United States |
| InflaRx Site #03 | Tampa | Florida | 33613 | United States |
| InflaRx Site #10 | St Louis | Missouri | 63110 | United States |
| InflaRx Site #05 | Columbus | Ohio | 43210 | United States |
| InflaRx Site #12 | Hershey | Pennsylvania | 17033 | United States |
| InflaRx Site #09 | Pittsburgh | Pennsylvania | 15213 | United States |
| InflaRx Site #01 | Richmond Hill | Ontario | Canada |
| InflaRx Site #21 | Rzeszów | 35-055 | Poland |
| InflaRx Site #20 | Wroclaw | 50-566 | Poland |
Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W.
| BG002 | Vilobelimab 2400 mg Q2W | Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W). |
| BG003 | 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 |
|
| Baseline Disease Characteristic: Duration of pyoderma gangrenosum | Mean | Standard Deviation | years |
|
| Baseline Disease Characteristic: Wound area at baseline | For two patients the measurements could not be obtained because photos were not taken correctly. | Mean | Standard Deviation | area [mm²] |
|
| Vilobelimab 800 mg Q2W |
Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W),with option to increase dose from Day 57 to 1600 mg every Q2W. |
| OG001 | Vilobelimab 1600 mg Q2W | Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W. |
| OG002 | Vilobelimab 2400 mg Q2W | Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W). |
|
|
| Secondary | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | Efficacy endpoint: Proportion of patients with a clinical response, defined as Physician's Global Assessment (PGA) score ≤3 of target ulcer at Visit V4, V6, V10 and V16 (End of Treatment [EOT]) (SAF). PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse | Safety Set | Posted | Count of Participants | Participants | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] | Efficacy endpoint: Kaplan-Meier analysis of time to first clinical remission (complete closure of target ulcer) defined as PGA score of ≤ 1, PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse | Safety Set | Posted | Median | Inter-Quartile Range | days | From treatment start until end of study (including observational visits), an average of 249 days |
|
|
|
| Secondary | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | Efficacy endpoint: Percentage change in wound area [percent change] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16. | Safety Set Only patients with an available wound area measurement at both relevant visits are included in the respective analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. | Posted | Mean | Standard Deviation | percent change | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | Efficacy endpoint: Percentage change in wound volume [percent change] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16. | Safety Set Only patients with an available wound volume measurement at both relevant visits are included in the respective analysis. Wound volume for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. Additionally, sometimes the pictures allowed to measure the wound area, but not the volume as several pictures had to be taken to estimate the volume adequately. | Posted | Mean | Standard Deviation | percent change | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | Efficacy endpoint: Rate of change per day in area of target ulcer [mm²/day] between Visits V1 and V16 (photographic assessment) | Safety Set Only patients with an available wound area measurement at both relevant visits (V1 and V16) are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. | Posted | Mean | Standard Deviation | mm²/day | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | Efficacy endpoint: Number of patients with a decrease in area of target ulcer of ≥ 50% by photographic assessment at Visit V16 (EOT) compared to Baseline | Safety Set Only patients with an available wound area measurement at baseline and V16 are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. | Posted | Count of Participants | Participants | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | Efficacy endpoint: Number of patients with a decrease in area of target ulcer of 100% at Visit V16 (EOT) compared to Baseline (remission) (photographic assessment) | Safety Set Only patients with an available wound area measurement at baseline and V16 are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. | Posted | Count of Participants | Participants | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | Efficacy endpoint: Degree of erythema of the target ulcer at Visit V4, V6, V10 and V16 (EOT) (investigator assessment) | Safety set | Posted | Count of Participants | Participants | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | Efficacy endpoint: Border elevation of the target ulcer at visits V4, V6, V10 and V16 (EOT) (investigator assessment) | Safety Set | Posted | Count of Participants | Participants | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | Efficacy endpoint: Percentage change from Baseline in pain assessed by Numeric Rating Scale (NRS) [percent change] at visits V4, V6, V10 and V16 (EOT) Mean (SD) The NRS is an 11-point scale (from 0 represent no pain to 10 representing the worst pain the subject can imagine). | Safety set Only patients with an available NRS at both relevant visits are included in the respective analysis. | Posted | Mean | Standard Deviation | percent change | From treatment start until V16 (Day 189) |
|
|
|
| Secondary | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | Efficacy endpoint: Percentage change from Baseline in Dermatology Life Quality Index (DLQI) [percent change] at visits V4, V6, V10, and V16 (EOT) The DLQI comprises 10 questions with single scores 0 (No effect on patient's life) to 3 (large effect on patient's life). The DLQI total score is calculated by summing up the score of each question resulting in a minimum of 0 (best) and a maximum of 30 (worst). | Safety set Only patients with an available DLQI at both relevant visits are included in the respective analysis. | Posted | Mean | Standard Deviation | percent change | From treatment start until V16 (Day 189) |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Vilobelimab 1600 mg Q2W | Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W. | 0 | 6 | 1 | 6 | 3 | 6 |
| EG002 | Vilobelimab 2400 mg Q2W | Group 3 (N=7) received vilobelimab 2400 mg every 2 weeks (Q2W). | 0 | 7 | 2 | 7 | 5 | 7 |
| Erysipelas | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Superinfection bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Wound infection pseudomonas | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Superficial vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
Publication of the results of the Study conducted at the Study Site shall not be made before the first multi-site publication by Sponsor occured within 18 months
| D012883 |
| Skin Ulcer |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| V6 |
|
|
| V10 |
|
|
| V16 |
|
|
| V1-V6 |
|
|
| V1-V16 |
|
|
| V6-V10 |
|
|
| V10-V16 |
|
|
| V1-V6 |
|
|
| V1-V16 |
|
|
| V6-V10 |
|
|
| V10-V16 |
|
|
| Slight (1) |
|
| Moderate (2) |
|
| Severe (3) |
|
| Very severe (4) |
|
| V6 |
|
|
| V10 |
|
|
| V16 |
|
|
| Slight (1) |
|
| Moderate (2) |
|
| Severe (3) |
|
| Very severe (4) |
|
| V6 |
|
|
| V10 |
|
|
| V16 |
|
|
| V1-V6 |
|
|
| V1-V10 |
|
|
| V1-V16 |
|
|
| V1-V6 |
|
|
| V1-V10 |
|
|
| V1-V16 |
|
|