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| ID | Type | Description | Link |
|---|---|---|---|
| FD-R-006325 | Other Grant/Funding Number | FDA OOPD | |
| 5R44CA192875-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of the 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection.
Funding Source: FDA OOPD
Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer and 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection. After the surgery, subjects were followed for 6 months for disease recurrence.
Ten subjects were enrolled in the study. Up to 21 additional subjects could have been enrolled in Stage 2, if safety and efficacy endpoints were not met. The dose was not changed. All subjects were followed for 6 months post-surgery for disease recurrence.
During and at the conclusion of the treatment period, subjects were monitored for local and systemic safety, tumor response due to the treatment, and systemic drug exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label, Single Arm Study of PRV111 | Experimental | Subjects received 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRV111 (Cisplatin Transmucosal System) | Drug | Each treatment visit will include one application of a permeation enhancer and then 2, 3 or 5 PRV111 (Cisplatin Transmucosal System) applications depending on the Stage subject is enrolled in. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses | The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2. This measures presents the number of tumor responses during the PRV111 treatment period | Subjects were evaluated for efficacy during the 4 treatment visits in the 21 days prior to surgery |
| Determine a Safe Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Dose-Limiting Toxicities | The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2. This measures presents the number of reported dose-limiting toxicities during the PRV111 treatment period | 4 treatment visits in the 21 days prior to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response (Tumor Volume Change From Baseline and Pre-op Visit, Approximately 21 Days Prior to Surgical Excision of the Tumor) | Assessed by clinical measurement at baseline and at the pre-op visit | Assessed within the 21 days prior to surgical excision of the tumor |
| Number of Loco-regional Recurrences |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manijeh Goldberg, PhD | CEO, Privo Technologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | United States | ||
| University of Cincinnati Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35977936 | Derived | Goldberg M, Manzi A, Birdi A, Laporte B, Conway P, Cantin S, Mishra V, Singh A, Pearson AT, Goldberg ER, Goldberger S, Flaum B, Hasina R, London NR, Gallia GL, Bettegowda C, Young S, Sandulache V, Melville J, Shum J, O'Neill SE, Aydin E, Zhavoronkov A, Vidal A, Soto A, Alonso MJ, Rosenberg AJ, Lingen MW, D'Cruz A, Agrawal N, Izumchenko E. A nanoengineered topical transmucosal cisplatin delivery system induces anti-tumor response in animal models and patients with oral cancer. Nat Commun. 2022 Aug 17;13(1):4829. doi: 10.1038/s41467-022-31859-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label, Single Arm Study of PRV111 | Subjects received 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects included in the baseline analysis were included in the safety population. Eight subjects were evaluable for the efficacy population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-Label, Single Arm Study of PRV111 | Subjects received 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits (within 3 weeks prior to their tumor surgery). Each treatment included one application of permeation enhancer prior to PRV111 administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses | The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2. This measures presents the number of tumor responses during the PRV111 treatment period | The efficacy population consists of all subjects who completed at least 3 PRV111 treatment visits and met all inclusion/exclusion criteria. The outcome measure is expressed as the count of participants who displayed a tumor response (At least 30% tumor volume reduction based on clinical measurements). | Posted | Count of Participants | Participants | Subjects were evaluated for efficacy during the 4 treatment visits in the 21 days prior to surgery |
|
Adverse event data was collected during the PRV111 treatment period up to the last follow up visit (up to 6 months post surgery).
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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 | Neoadjuvant PRV111 (Safety Population) | Subjects received at least 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failure to Thrive | Metabolism and nutrition disorders | Systematic Assessment | This event was reported as severe and not related to study treatment by the investigator. SAE of failure to thrive, which occurred 116 days post last dose of PRV111. The SAE was 124 days after the last administration of PRV111. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| [During PRV111 Treatment Period] Oral Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manijeh Goldberg | Privo Technologies | 9785872322 | mgoldberg@privotechnologies.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2020 | Jun 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2020 | Jun 8, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2020 | Dec 1, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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Phase 1/2, Open-Label, Single-Arm
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|
Number of loco-regional recurrences at follow-up |
| Assessed 1, 3 and 6 months post surgery |
| Tumor and Lymph Node (if Available) Platinum Levels | Levels of platinum content in tumor tissue and/or lymph tissue, using a validated bioanalytical ICP-MS method. Resected tissues were digested via microwave and used to evaluate the amount of cisplatin delivered by PRV111 (Correlated to the amount of platinum detected). | 21 days from baseline through surgical excision of the tumor |
| Technical Success - Residual Cisplatin Levels Post-application | Platinum content in each residual PRV111, using a validated bioanalytical ICP-MS method and the results for all applications were averaged. | 4 treatment visits in the 21 days prior to surgery |
| Systemic Platinum Levels (Cmax) | Levels of platinum content in blood, using a validated bioanalytical ICP-MS method. Blood drawn was digested via microwave and used to evaluate the amount of systemic cisplatin exposure from PRV111 (Correlated to the amount of platinum detected). A single value for Cmax was calculated by averaging values for all subjects. | Cmax is a single value of the highest concentration of platinum in the blood reported from samples taken post-dose across all 4 treatment visits (Baseline [0], 30, 60, and 120 minutes at Visits 1-4) |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| Ben Taub Hospital | Houston | Texas | 77030 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center School of Dentistry | Houston | Texas | 77054 | United States |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects who completed at least 3/4 planned PRV111 treatment visits. |
|
|
| Primary | Determine a Safe Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Dose-Limiting Toxicities | The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2. This measures presents the number of reported dose-limiting toxicities during the PRV111 treatment period | Patients treated with at least 1 PRV111 were included | Posted | Number | dose-limiting toxicities | 4 treatment visits in the 21 days prior to surgery |
|
|
|
| Secondary | Tumor Response (Tumor Volume Change From Baseline and Pre-op Visit, Approximately 21 Days Prior to Surgical Excision of the Tumor) | Assessed by clinical measurement at baseline and at the pre-op visit | Subjects who received at least 3 PRV111 treatments and met all inclusion/exclusion criteria. | Posted | Mean | Full Range | percentage of tumor volume reduction | Assessed within the 21 days prior to surgical excision of the tumor |
|
|
|
| Secondary | Number of Loco-regional Recurrences | Number of loco-regional recurrences at follow-up | Subjects received at least 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery. | Posted | Number | number of locoregional recurrences | Assessed 1, 3 and 6 months post surgery |
|
|
|
| Secondary | Tumor and Lymph Node (if Available) Platinum Levels | Levels of platinum content in tumor tissue and/or lymph tissue, using a validated bioanalytical ICP-MS method. Resected tissues were digested via microwave and used to evaluate the amount of cisplatin delivered by PRV111 (Correlated to the amount of platinum detected). | Posted | Mean | Full Range | µg/g | 21 days from baseline through surgical excision of the tumor |
|
|
|
| Secondary | Technical Success - Residual Cisplatin Levels Post-application | Platinum content in each residual PRV111, using a validated bioanalytical ICP-MS method and the results for all applications were averaged. | Each patch was analyzed | Posted | Mean | Standard Deviation | percentage of drug released | 4 treatment visits in the 21 days prior to surgery |
|
|
|
| Secondary | Systemic Platinum Levels (Cmax) | Levels of platinum content in blood, using a validated bioanalytical ICP-MS method. Blood drawn was digested via microwave and used to evaluate the amount of systemic cisplatin exposure from PRV111 (Correlated to the amount of platinum detected). A single value for Cmax was calculated by averaging values for all subjects. | Posted | Mean | Full Range | µM | Cmax is a single value of the highest concentration of platinum in the blood reported from samples taken post-dose across all 4 treatment visits (Baseline [0], 30, 60, and 120 minutes at Visits 1-4) |
|
|
|
| 1 |
| 10 |
| 3 |
| 10 |
| 10 |
| 10 |
|
| Post-Surgical Infected Seroma | Infections and infestations | Systematic Assessment | This event was expected from standard of care surgery and determined as possibly related to treatment. The infected seroma followed 2 surgeries, (tumor resection/neck dissection and reconstructive surgery). It resolved with sequelae in the follow-up. |
|
| Surgical Complication | Injury, poisoning and procedural complications | Systematic Assessment | This event was considered not related to study treatment by the investigator and the event resolved during the follow-up period. The SAE of a procedural complication related to surgery was reported post-operatively 11 days after the last PRV111 dose |
|
| [During PRV111 Treatment Period] Glossodynia | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Lip Blister | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Oral Mucosal Blistering | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Tongue Blistering | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Tongue Discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Angina Pectoris | Cardiac disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] oropharyngeal pain | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] salivary duct inflammation | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Swollen Tongue | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Gastro Esophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Tongue Ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Non-cardiac Chest pain | General disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Oedema Peripheral | General disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Palate Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| [During PRV111 Treatment Period] Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Headache | Nervous system disorders | Systematic Assessment |
|
| [During PRV111 Treatment Period] Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| [Post-PRV111 Treatment, Post-Surgery] Procedural Pain | Injury, poisoning and procedural complications | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Procedural Complication | Injury, poisoning and procedural complications | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Anxiety | Psychiatric disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Constipation | Gastrointestinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Dysphagia | Gastrointestinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Malnutrition | Gastrointestinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Post-Procedural Complication | Injury, poisoning and procedural complications | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Nausea | Gastrointestinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Post Procedural Oedema | Injury, poisoning and procedural complications | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Procedural Nausea | Injury, poisoning and procedural complications | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Pyrexia | General disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Infected seroma | Infections and infestations | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Gastroesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] Fatigue | General disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] post operative hypertension | Injury, poisoning and procedural complications | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] skin graft failure | Injury, poisoning and procedural complications | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] weight decreased | Investigations | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] fluid overload | Metabolism and nutrition disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] hypervolemia | Metabolism and nutrition disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] lactic acidosis | Metabolism and nutrition disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] malnutrition | Metabolism and nutrition disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] dysarthria | Nervous system disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] agitation | Psychiatric disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] insomnia | Psychiatric disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] urinary retention | Renal and urinary disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] skin disorder | Skin and subcutaneous tissue disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] swelling face | Skin and subcutaneous tissue disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] hypotension | Vascular disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
| [Post-PRV111 Treatment, Post-Surgery] shock | Vascular disorders | Systematic Assessment | post-PRV111 treatment period; post-surgery |
|
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |