Study: NCT03502148

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: 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.
Frequency: 1 affected / 10 at risk

Adverse event: Post-Surgical Infected Seroma
Serious: yes
Organ System: Infections and infestations
Notes: 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.
Frequency: 1 affected / 10 at risk

Adverse event: Surgical Complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 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
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Oral Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Lip Blister
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Oral Mucosal Blistering
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Tongue Blistering
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Tongue Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Angina Pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] salivary duct inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Swollen Tongue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Gastro Esophageal Reflux Disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Dry Mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Tongue Ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Non-cardiac Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Oedema Peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Palate Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Decreased Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: [During PRV111 Treatment Period] Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Procedural Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: post-PRV111 treatment period; post-surgery
Frequency: 6 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Procedural Complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: post-PRV111 treatment period; post-surgery
Frequency: 3 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Acute Respiratory Failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Malnutrition
Serious: no
Organ System: Gastrointestinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Post-Procedural Complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Post Procedural Oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Procedural Nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Pyrexia
Serious: no
Organ System: General disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Infected seroma
Serious: no
Organ System: Infections and infestations
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Gastroesophageal Reflux Disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] Fatigue
Serious: no
Organ System: General disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] post operative hypertension
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] skin graft failure
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] weight decreased
Serious: no
Organ System: Investigations
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] fluid overload
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] hypervolemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] lactic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 2 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] dysarthria
Serious: no
Organ System: Nervous system disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] agitation
Serious: no
Organ System: Psychiatric disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] acute pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] hypotension
Serious: no
Organ System: Vascular disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk

Adverse event: [Post-PRV111 Treatment, Post-Surgery] shock
Serious: no
Organ System: Vascular disorders
Notes: post-PRV111 treatment period; post-surgery
Frequency: 1 affected / 10 at risk