Open-Label Proof of Concept Study of VP-315 in Basal Cell... | NCT05188729

Name	Class
Instat Clinical Research	UNKNOWN
HeartcoR Solutions	UNKNOWN
Myonex	UNKNOWN
Vial Health Technology, Inc

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1 - Cohort 1: Dose Escalation VP-315 2 mg	Experimental	Cohort 1: Starting total daily dose of VP-315 will be 2 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week
Part 1 - Cohort 2: Dose Escalation VP-315 3 mg	Experimental	Cohort 2: Starting total daily dose of VP-315 will be 3 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 3 mg on Day 1, 4 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week
Part 1 - Cohort 3: Dose Escalation VP-315 4 mg	Experimental	Cohort 3: Starting total daily dose of VP-315 will be 4 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 4 mg on Day 1, 5 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week
Part 1 - Cohort 4: Dose Escalation VP-315 5 mg	Experimental	Cohort 4: Starting total daily dose of VP-315 will be 5 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 5 mg on Day 1, 6 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Part 1: VP-315 3 Day Dosing/Week	Drug	2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Percentage of Subjects With Discontinuations Due to Adverse Events	Part 1: Percentage of subjects that discontinued the study due to adverse event	Up to 9 weeks
Part 1: Percentage of Subjects With Dose-limiting Toxicities (DLTs)	Subjects with pre-determined dose-limiting toxicities such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)	Day 4 (Safety Assessment)
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity	Cutaneous injection site reactions are defined as the following preferred terms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site exfoliation, Injection site erosion, Injection site ulcer, Injection site necrosis. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA. Subjects having more than one event may appear in more than one System Organ Class or Preferred Term but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur.	Up to 9 weeks
Part 2: Percent of Subjects With Adverse Events	Part 2: Percent of subjects with adverse events, treatment-related AEs	Up to 15 weeks
Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events	Part 2: Percentage of subjects with study discontinuations due to adverse events.	Up to 15 weeks
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)

Secondary Outcomes

Measure	Description	Time Frame
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision	Clinical clearance of Target Lesion at excision as determined by visual assessment (no residual tumor seen on visual inspection). Clinical assessment using Physician Global Assessment (PGA). PGA scale: 100% Improvement, no visible tumor; 75% to less than 100% improvement, 50% to less than 75% improvement, 25% to less than 50% improvement, Up to 25% improvement, No change, Worse.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults ≥18 years of age
Clinically suspected BCC with at least 1 and up to 5 eligible lesion(s) suitable for biopsy and excision
Willing to refrain from using nonapproved topical agents on, or within 2 cm of, the target BCC lesions and surrounding areas during the treatment period. Subjects should use topical agents that are gentle (eg, Aquaphor, CeraVe) and will not irritate the skin in these areas.
Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study
Written informed consent obtained, including consent for tissue to be examined by the central dermatopathologist and stored by the Sponsor or designee
Willing to undergo BCC surgical excision procedure of target and nontarget BCC lesions after study treatment
Willing to delay surgical excision of target and nontarget BCC lesions until the end of treatment (EOT) visit
Provides written consent to allow photographs of the target and nontarget BCC lesion to be used as part of the study data
Willing to practice a highly effective method of birth control while on study and until 4 weeks after the last treatment. Highly effective birth control includes sexual abstinence, vasectomy, bilateral tubal ligation/occlusion, or a condom with spermicide (men) combined with hormonal birth control or intrauterine device in women.

BCC Lesion Eligibility

Eligible lesions are those that meet the BCC lesion eligibility specifications described herein, from samples that are either from:

HISTORICAL punch or shave biopsies (i.e., samples collected according to clinical standard of care collected within the 90 days prior to W1D1);
A 2-mm punch biopsy collected within 90 days of W1D1 for suspected BCC ≥0.5 cm to 1.0 cm, and 3-mm punch biopsy for suspected BCC >1.0 cm to 2.0 cm; or
A shave biopsy performed according to standard of care to include superficial or middle papillary dermis collected within 90 days of W1D1.

Lesions must meet the following criteria to be eligible for treatment

BCC Lesion Inclusion Criteria

For punch biopsies: the size of the lesion(s) must be ≥0.5 cm and </=2 cm in the longest diameter prior to punch biopsy.
Histological diagnosis of nodular, micronodular, or superficial BCC, as confirmed by punch or shave biopsy performed within 90 days of W1D1. (NOTE: HISTORICAL punch or shave biopsies are acceptable, provided that the biopsy was performed according to clinical standard of care and was collected within the 90 days prior to Screening.) Subject Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

Exclusion Criteria

Presence of known or suspected systemic cancer
Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit
Treatment with systemic immunotherapy, immunomodulators or immunosuppressants within the 12 weeks prior to the screening period
Genetic or nevoid conditions (eg, Gorlin / basal cell nevus syndrome, xeroderma pigmentosum)
Clinically significant laboratory values, as assessed by the investigator, for the tests listed in the Schedule of Assessments, including:
1. serum creatinine >1.5× the upper limits of normal and
2. serum tryptase concentration >11.4 ng/mL
Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the subject at undue risk, such as, but not limited to:
1. Uncontrolled infection or infection requiring antibiotics
2. Uncontrolled cardiac failure: Classification III or IV New York Heart Association
3. Subjects presenting with a systolic BP <110 mmHg and/or diastolic BP <70 mmHg at Screening or Week 1 Day 1 or a history of cerebrovascular or cardiac disorders, or subjects at particular risk of sequelae following a short hypotensive episode.
4. Uncontrolled systemic or gastrointestinal inflammatory conditions
5. Known bone marrow dysplasia
6. History of positive tests for human immunodeficiency virus/acquired immunodeficiency syndrome or active hepatitis B or C
7. History of systemic autoimmune disease requiring anti-inflammatory or immunosuppressive therapy within 3 months prior to Day 1, with the following exceptions:
i. Subjects with a history of autoimmune thyroiditis are eligible provided the subject requires only thyroid hormone replacement therapy and disease has been stable for ≥1 year

ii. Subjects with well-controlled type I diabetes (in the opinion of the investigator) are eligible

h. Known mast cell activation syndrome, mastocytosis, or chronic idiopathic urticaria
Known sensitivity to any of the ingredients in the study medication
Elective surgery within 4 weeks prior to the screening visit, during the study, or 4 weeks after the treatment period
Evidence of current chronic alcohol or drug abuse
Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit
In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study
Females who are pregnant or breastfeeding

BCC Lesion Exclusion Criteria

Recurrent or previously treated lesions
Lesions within 1 cm of the eyelids or lips, or on the hands, feet, ears, nose, and genitalia
Histological evidence of any other tumor in the biopsy specimen
Histological evidence of infiltrative, desmoplastic, sclerosing, or morpheaform BCC subtypes in the biopsy specimen
Medium- and high-risk basal cell carcinomas as defined by the National Comprehensive Cancer Network (NCCN) or Mohs Appropriate Use Criteria (ie, BCCs eligible for Mohs surgery).

TARGET LESION EXCLUSION ONLY:
For subjects with severe stasis dermatitis, target BCC lesions may not be on the lower extremities
Within 2 cm of the target BCC lesion(s):
1. Treatment with the following topical agents within the 12 weeks prior to the screening visit: aminolevulinic acid, 5-fluorouracil, corticosteroids, diclofenac, imiquimod, ingenol mebutate
2. Treatment with surgical excision, or curettage within the 2 weeks prior to the screening visit
3. Evidence of dermatological disease or confounding skin condition that may interfere with clinical evaluation (ie, psoriasis, atopic dermatitis, eczema, propensity to form keloids or hypertrophic scarring)
4. Use of topical immunomodulators during study
Within 5 cm of the target BCC lesion(s): history of any skin cancer, except for other currently identified target and nontarget BCC lesions
Target BCC lesion is in the area of prior resurfacing procedure with CO2 laser or any photodynamic and phototherapy treatment within the 3 months prior to the screening visit

Name	Affiliation	Role
Neal Bhatia, MD	Therapeutics Clinical Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Therapeutics Clinical Research		San Diego	California	92123	United States
ClearlyDerm

ID	Title	Description
FG000	Part 1 - Cohort 1 - Intra-subject Dose Escalation	2 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 13, 2023	Apr 15, 2025

Arm/Group Information

ID	Title	Description
BG000	Part 1 - All Cohorts	Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
BG001	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
BG002	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose	VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
BG003	Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)	VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses. Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
BG004	Part 2 - Cohort 4 Expansion Optimal Dosing	VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses. Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
BG005	Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)	VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses. Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
BG006	Part 2 - Cohort 5 Expansion: Optimal	VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses. Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
BG007	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Percentage is calculated using the number of subjects in the column heading as the denominator.

Baseline is defined as the most recent non-missing value prior to study treatment.

Mean

Standard Deviation

years

Participants

Units	Counts
Participants	BG00010 BG0016 BG0023 BG003

Title

Denominators

Categories

Title	Measurements
	OG0000

Primary

Part 1: Percentage of Subjects With Dose-limiting Toxicities (DLTs)

Subjects with pre-determined dose-limiting toxicities such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)

Safety Population - Part 1 only. Due to the small number of subjects in each Cohort for Part 1, data for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.

Posted

Count of Participants

Participants

Day 4 (Safety Assessment)

ID	Title	Description
OG000	Part 1 - All Cohorts	Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.

Units	Counts

Primary

Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity

Cutaneous injection site reactions are defined as the following preferred terms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site exfoliation, Injection site erosion, Injection site ulcer, Injection site necrosis.

The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA.

Subjects having more than one event may appear in more than one System Organ Class or Preferred Term but are counted at most once per each SOC and PT at the maximum severity.

Cutaneous injection site reactions are types of reactions that can be expected to occur.

Safety Population. Due to the small number of subjects in each Cohort for Part 1, data for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.

Posted

Count of Participants

Participants

Up to 9 weeks

ID	Title	Description
OG000	Part 1: All Cohorts	Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.

Primary

Part 2: Percent of Subjects With Adverse Events

Part 2: Percent of subjects with adverse events, treatment-related AEs

Safety Population

Posted

Count of Participants

Participants

Up to 15 weeks

ID	Title	Description
OG000	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
OG001	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose	VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).

Primary

Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events

Part 2: Percentage of subjects with study discontinuations due to adverse events.

Enrolled Subjects

Posted

Count of Participants

Participants

Up to 15 weeks

ID	Title	Description
OG000	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
OG001	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose	VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).

Primary

Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)

Subjects with pre-determined TRAEs of SI such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)

Safety Population

Posted

Count of Participants

Participants

Treatment Days up to 2 weeks

ID	Title	Description
OG000	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
OG001	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose	VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).

Primary

Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity

Evaluation of the tissue condition at the treatment site for the presence and severity of each of the following cutaneous reactions; Erythema, Induration, Swelling, Blister Formation, Desquamation, Erosion, Ulceration, Necrosis by a scale of None; Mild; Moderate; Severe. Subjects having more than one event may appear in more than one SOC or PT but are counted at most once per each SOC and PT at the maximum severity.

Cutaneous injection site reactions are types of reactions that can be expected to occur. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA

Safety Population

Posted

Count of Participants

Participants

Up to 105 days

ID	Title	Description
OG000	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
OG001	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose

Secondary

Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision

Clinical clearance of Target Lesion at excision as determined by visual assessment (no residual tumor seen on visual inspection). Clinical assessment using Physician Global Assessment (PGA). PGA scale: 100% Improvement, no visible tumor; 75% to less than 100% improvement, 50% to less than 75% improvement, 25% to less than 50% improvement, Up to 25% improvement, No change, Worse.

Full Analysis Population. Participants with the Physician Global Assessment completed at the End of Treatment Visit. Report is based on Target Lesion 01 and Target Lesion 2 data in separate rows.

Posted

Count of Units

Target Lesions

Day 84-91

Target Lesions

ID	Title	Description
OG000	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
OG001	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose

Secondary

Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision

Percentage of Subjects with histological clearance of treated lesion(s) at excision. Histologic clearance confirmed by central dermatopathologist.

Percentage is calculated using the number of subjects with non-missing responses within lesion as the denominator.

*Scar indicates complete histologic clearance

Full Analysis Population. Participants with Target Lesion(s) excised and histology confirmed by central dermatopathologist. Report is based on Target Lesion 01 and Target Lesion 2 data presented in separate rows. NOTE: All participants had a Target Lesion 1, however, not all participants had a Target Lesion 2, therefore, the numbers are not the same.

Posted

Count of Units

Target Lesions

Day 84-91

Target Lesions

ID	Title	Description
OG000	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
OG001	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose

Secondary

Part 2: Mean Estimated Remaining Tumor Volume at Excision

Estimate of remaining tumor volume (necrotic cells:tumor cells) at excision by central dermatopathologist

Scale: 0 = None Remaining to 100 = All Remaining.

Full Analysis Population

Posted

Mean

Standard Deviation

units on a scale

Day 84-91

ID	Title	Description
OG000	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
OG001	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose	VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).

Secondary

Part 2 (Cohorts 4 and 5 Expansion Groups): Plasma Concentrations of VP-315

Pharmacokinetics (PK) of an 8 mg dose of VP-315 administered with the optimal dosing regimen

PK Population - Part 2, Cohorts 4 Expansion and 5 Expansion subjects that consented to participate. Includes subjects in Safety Population with quantifiable PK concentration data.

Posted

Mean

Standard Deviation

h*ng/mL

Day 1-2

ID	Title	Description
OG000	Part 2 - Cohort 4 Expansion Optimal Dosing	VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses. Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
OG001	Part 2 - Cohort 5 Expansion: Optimal	VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses. Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1 - All Cohorts	Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan. Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg. Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.	10	0	10	10	10
EG001	Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose	VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.	6	0	6	6	6
EG002	Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose	VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses). Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).	3	0	3	3	3
EG003	Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)	VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses. Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).	10	1	10	10	10
EG004	Part 2 - Cohort 4 Expansion Optimal Dosing	VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses. Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).	26	0	26	26	26
EG005	Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)	VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses. Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).	10	0	10	10	10
EG006	Part 2 - Cohort 5 Expansion: Optimal	VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses. Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).	27	0	27	27	27

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injection site erythema	General disorders	MedDRA 24.1	Systematic Assessment	and administration site conditions	EG0007 events7 affected10 at risk EG0016 events6 affected6 at risk EG0023 events3 affected3 at risk EG00310 events10 affected10 at risk
Injection site induration	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0008 events8 affected10 at risk EG0015 events5 affected6 at risk EG0021 events1 affected3 at risk EG003
Injection site necrosis	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0007 events7 affected10 at risk EG0014 events4 affected6 at risk EG0022 events2 affected3 at risk EG003
Injection site swelling	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0007 events7 affected10 at risk EG0013 events3 affected6 at risk EG0022 events2 affected3 at risk EG003
Injection site erosion	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0006 events6 affected10 at risk EG0011 events1 affected6 at risk EG0021 events1 affected3 at risk EG003
Injection site exfoliation	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0007 events7 affected10 at risk EG0011 events1 affected6 at risk EG0021 events1 affected3 at risk EG003
Injection site ulcer	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0005 events5 affected10 at risk EG0011 events1 affected6 at risk EG0020 events0 affected3 at risk EG003
Injection site pain	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0000 events0 affected10 at risk EG0011 events1 affected6 at risk EG0022 events2 affected3 at risk EG003
Injection site vesicles	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0003 events3 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Injection site oedema	General disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Peripheral swelling	General disorders	MedDRA 24.1	Systematic Assessment		EG0001 events1 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment		EG0002 events2 affected10 at risk EG0011 events1 affected6 at risk EG0020 events0 affected3 at risk EG003
Hypertrophic Scar	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Blood pressure diastolic decreased	Investigations	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Body temperature increased	Investigations	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Blood pressure decreased	Investigations	MedDRA 24.1	Systematic Assessment		EG0001 events1 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment		EG0001 events1 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment		EG0001 events1 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Post procedural erythema	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Non-small cell lung carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment		EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment		EG0001 events1 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Erythema; Injection site erythema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	General disorders and administration site conditions	EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003

ID	Term
D002280	Carcinoma, Basal Cell
D012878	Skin Neoplasms
D002277	Carcinoma
D009369	Neoplasms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D018295	Neoplasms, Basal Cell
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Units	Counts
Participants	BG00010 BG0016 BG0023 BG00310 BG00426 BG00510 BG00627 BG00792
Target Lesions	BG00012 BG0017 BG0023 BG00311 BG004

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial Fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG0031 events1 affected10 at risk EG0040 events0 affected26 at risk EG0050 events0 affected10 at risk EG0060 events0 affected27 at risk
Influenza	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected6 at risk EG0020 events0 affected3 at risk EG003