TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05227118

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Intestinal pseudo-obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Electric shock sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 22 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT05227209

Adverse event: Sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 64 at risk

Adverse event: Hyperprolactinaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 64 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 64 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 64 at risk

Adverse event: Blood prolactin increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 64 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 64 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 4 affected / 64 at risk
Study: NCT05227820

Adverse event: Elevated Lipase
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: one participant showed evidence at one time point of elevated lipase on safety labs. Labs returned to normal on follow up.
Frequency: 1 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: One patient reported dizziness during a study check in
Frequency: 1 affected / 23 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: One patient reported a dry mouth in a regular study check up
Frequency: 1 affected / 23 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: One patient demonstrated a lab value indicating a urinary tract infection following a safety lab visit. Patient recovered after antiviral treatment.
Frequency: 1 affected / 23 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: One patient demonstrated an elevated heart rate at a study safety visit
Frequency: 1 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: One patient reported having suffered and recovered from a bout of diarrhea at a study check in
Frequency: 1 affected / 23 at risk

Adverse event: COVID-19 Infection
Serious: no
Organ System: Infections and infestations
Notes: One patient experienced an infection with the COVID-19 virus during the trial.
Frequency: 1 affected / 23 at risk

Adverse event: Joint injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One patient reported having tripped and injured their knee during the trial.
Frequency: 1 affected / 23 at risk
Study: NCT05228132

Adverse event: Not Device Related-Septic Shock
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis - bacteraemia, viraemia and fungaemia - Day 17 - Not Related to Device or Procedure
Frequency: 1 affected / 7 at risk

Adverse event: Device Related-Thrombosis in device
Serious: yes
Organ System: Product Issues
Notes: Thrombosis in device - Clotted Catheter - Day 55 - Likely device related, Unlikely procedure related
Frequency: 1 affected / 7 at risk

Adverse event: Device Related-Thrombosis in device
Serious: yes
Organ System: Product Issues
Notes: Thrombosis in device - Clotted Catheter - Day 20 - Likely device related, Not procedure related
Frequency: 1 affected / 7 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Procedural Pain - Acute Post-Op Pain - Day 0 - Not device related, Likely procedure related
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness - Day 40 - Not procedure or device related
Frequency: 1 affected / 7 at risk
Study: NCT05228457

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: A mild headache occurred after the participant received TMS. It was of low intensity and resolved within a few hours without any intervention.
Frequency: 5 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: A mild headache occurred after the participant received TMS. It was of low intensity and resolved within a few hours without any intervention.
Frequency: 2 affected / 13 at risk
Study: NCT05228730

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT05233163

Adverse event: Transient episode of symptomatic hypotension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Increased urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Eye stye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Leg cramping
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Lower extremity pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Lower extremity wound infection
Serious: no
Organ System: Infections and infestations
Notes: Skin trauma prior to study enrollment; initial improvement followed by subsequent worsening of wound
Frequency: 1 affected / 15 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Mechanical fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 15 at risk

Adverse event: Tingling sensation in arm
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Foot pain, acute onset
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Head congestion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: Irregular heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Disruption in taste and appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Bilateral groin intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT05233566

Adverse event: Ramsay Hunt syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Postoperative Apnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Subjective arm/leg weakness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Deep Venous Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Death (underlying etiology unable to be determined)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Blisters around incision
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fever and chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk
Study: NCT05234957

Adverse event: undercorrection/recurrence
Serious: no
Organ System: Eye disorders
Notes: postoperative deviation equal or greater than 10 prism diopter exotropia/phoria at distant and/or near fixation.
Frequency: 8 affected / 20 at risk

Adverse event: undercorrection/recurrence
Serious: no
Organ System: Eye disorders
Notes: postoperative deviation equal or greater than 10 prism diopter exotropia/phoria at distant and/or near fixation.
Frequency: 4 affected / 20 at risk

Adverse event: overcorrection
Serious: no
Organ System: Eye disorders
Notes: postoperative deviation equal or greater than 10 prism diopter esotropia/phoria at distant and/or near fixation.
Frequency: 1 affected / 20 at risk
Study: NCT05236257

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 42 at risk
Study: NCT05239455

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk
Study: NCT05239598

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk
Study: NCT05241288

Adverse event: COPD Exacerbation with hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: Metastatic Lung Cancer
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Progression of known lung cancer leading to death.
Frequency: 1 affected / 54 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 54 at risk
Study: NCT05241470

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 52 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 53 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Respiratory Depression related to congestive heart failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Poor organ function
Serious: yes
Organ System: General disorders
Notes: Kidney, heart, liver
Frequency: 1 affected / 54 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 54 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 54 at risk
Study: NCT05244187

Adverse event: Paraesthesia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 59 at risk

Adverse event: difficulty bending knee
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 59 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Somnolence
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 61 at risk
Study: NCT05244226

Adverse event: Altered mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk
Study: NCT05245071

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 22 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Keratopathy
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 22 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 22 at risk
Study: NCT05245682

Adverse event: Radiation Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 9 affected / 10 at risk

Adverse event: Throat/Tumor Pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 10 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 10 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk
Study: NCT05246280

Adverse event: Skin laceration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: The sbj, a 78-year-old female, fell from a ladder and was hospitalized due to a scalp laceration. The scalp laceration was serious due to hospitalization, moderate in intensity, and unexpected. All events were reported as definitely not related.
Frequency: 1 affected / 169 at risk

Adverse event: Blunt abdominal trauma
Serious: yes
Organ System: Social circumstances
Notes: The subject, a 63-year-old female, was in a motor vehicle accident and hospitalized due to blunt abdominal trauma, abdominal ecchymosis and right index finger pain. All events were reported as definitely not related.
Frequency: 1 affected / 169 at risk

Adverse event: snycope
Serious: yes
Organ System: Cardiac disorders
Notes: The subject, a 70-year-old female, was hospitalized due to syncope. It was reported as definitely not related to the investigational drug or procedure.
Frequency: 1 affected / 169 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: General disorders
Notes: The subject, a 74-year-old female, was hospitalized due to appendicitis perforated on 04 July 2023. It was reported as definitely not related to the investigational drug or procedure.
Frequency: 1 affected / 169 at risk

Adverse event: Non-Cardiac Atypical Chest Pain
Serious: yes
Organ System: Cardiac disorders
Notes: The subject, a 57-year-old female, was hospitalized due to noncardiac atypical chest pain on 02 March 2023. It was reported as definitely not related to the investigational drug or procedure.
Frequency: 1 affected / 169 at risk
Study: NCT05248867

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 156 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 156 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 482 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 482 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 482 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 145 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 437 at risk
Study: NCT05248997

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 99 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Electrocardiogram PR shortened
Serious: no
Organ System: Investigations
Frequency: 1 affected / 105 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk
Study: NCT05249127

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 urosepsis. Serious criteria: hospitalization. Not related to 64Cu-SAR-bisPSMA. Commenced Day 3 post injection. Resolved in 5 days.
Frequency: 1 affected / 52 at risk