TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03359811

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 33 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Low urinary input
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 33 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 33 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Intraabdominal Abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 35 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 35 at risk

Adverse event: Low urinary input
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 35 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 35 at risk
Study: NCT03359889

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT03360071

Adverse event: systemic reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: mild systemic reaction defined by local inflammation and/or flushing or hives.
Frequency: 3 affected / 17 at risk
Study: NCT03360656

Adverse event: Chills
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 30 at risk

Adverse event: Insufficient cooling
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Adverse effects on systemic blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 30 at risk
Study: NCT03360747

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Loss of libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk
Study: NCT03361137

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

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

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

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Adhesiolysis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 9 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk
Study: NCT03361176

Adverse event: Erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erosion of skin within the submental treatment area
Frequency: 1 affected / 20 at risk

Adverse event: Neck pain secondary to motor vehicle accident
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT03361423

Adverse event: Feeling hot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 126 at risk

Adverse event: Numbness of the arm
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Pain in the arm
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Redness of the skin at the treatment area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 126 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Feeling hot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 126 at risk

Adverse event: Redness of the skin at the treatment area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Neck and shoulder pain
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 126 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 126 at risk
Study: NCT03362515

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: increased headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: burning sensation in throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT03362957

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 14 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 14 at risk

Adverse event: Skin changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: bleeding at access site
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Skin changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Skin Ischemia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT03363165

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Colonoscopy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pain or discomfort at the study drug injection sites
Serious: no
Organ System: General disorders
Frequency: 7 affected / 18 at risk

Adverse event: Redness or irritation at the study drug injection sites
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Stayed overnight in the hospital
Serious: no
Organ System: General disorders
Frequency: 6 affected / 18 at risk

Adverse event: Lower extremity revascularization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Fall and fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Palpitations and anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Blood transfusion/anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Muscle strain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Lower extremity arterial bypass surgery
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain or discomfort at the study drug injection sites
Serious: no
Organ System: General disorders
Frequency: 13 affected / 21 at risk

Adverse event: Redness or irritation at the study drug injection sites
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Venous thromboembolism (deep venous thrombosis or pulmonary embolism)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Stayed overnight in the hospital
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk
Study: NCT03363659

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: 60 year old female with a history of Glioblastoma multiforme, presented with increased fatigue and new onset jaundice. Liver biopsy, which favored drug-induced liver injury likely due to chemotherapy agents.
Frequency: 1 affected / 13 at risk
Study: NCT03363906

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 23 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk
Study: NCT03364023

Adverse event: Symptomatic Intracranial Hemorrhage (sICH)
Serious: yes
Organ System: Nervous system disorders
Notes: Symptomatic Intracranial Hemorrhage (sICH) at 24 ± 8 hrs post procedure
Frequency: 14 affected / 183 at risk
Study: NCT03364192

Adverse event: Non-Serious Adverse Event-Unrelated to Study Participation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk
Study: NCT03364647

Adverse event: Patellar Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk
Study: NCT03364686

Adverse event: Weakly positive antibodies
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Subject developed transient antibiotin antibodies without evidence of hemolysis. The test was weakly positive at Visit 8 and was undetected at Visit 10.
Frequency: 1 affected / 6 at risk
Study: NCT03364738

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 22 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 22 at risk

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

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 22 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 22 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 22 at risk
Study: NCT03365011

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Temporary, fully resolved
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Temporary, fully resolved
Frequency: 1 affected / 40 at risk

Adverse event: Panic attack
Serious: no
Organ System: General disorders
Notes: Temporary, fully resolved
Frequency: 1 affected / 40 at risk
Study: NCT03365154

Adverse event: Other
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient scheduled for tracheostomy revision. Received a feeding tube and developed constipation.
Frequency: 1 affected / 10 at risk

Adverse event: Amputation below the knee
Serious: yes
Organ System: Infections and infestations
Notes: Left foot/toe pain due to gangrene with amputation of non-treated limb
Frequency: 1 affected / 10 at risk

Adverse event: Bleeding complication requires transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: GI bleed
Frequency: 1 affected / 10 at risk

Adverse event: Other
Serious: yes
Organ System: Infections and infestations
Notes: Non-healing wound treated with Vancomycin; Anemia requiring transfusion; acute kidney injury in setting of hyperglycemis treated with drugs
Frequency: 1 affected / 10 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 1 affected / 10 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Notes: Routine care visit revealed skin disorder. Treated with Bactrim DS
Frequency: 1 affected / 10 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Notes: Non-healing wound treated with Keflex
Frequency: 1 affected / 10 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Notes: Hepatitis C with hepatic steatosis. Discharged and referred to hepatoloogy.
Frequency: 1 affected / 10 at risk
Study: NCT03366012

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk
Study: NCT03366194

Adverse event: Hyperpigmentation transient
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Hyperpigmentation of treatment area that lasts longer than 2 weeks but less than six months
Frequency: 2 affected / 34 at risk
Study: NCT03366298

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 12 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 12 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 12 at risk
Study: NCT03366649

Adverse event: Atrial fibrillation + congestive heart failure (CHF)
Serious: yes
Organ System: Cardiac disorders
Notes: Hospital admission due to Atrial fibrillation + congestive heart failure (CHF)
Frequency: 1 affected / 26 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Hospital admission due to Atrial Flutter
Frequency: 1 affected / 26 at risk

Adverse event: Acute cholecystitis with perforated gallbladder
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospital admission due to acute cholecystitis with perforated gallbladder
Frequency: 1 affected / 26 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Notes: Hospital admission due to syncope.
Frequency: 1 affected / 26 at risk
Study: NCT03366792

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 46 at risk
Study: NCT03367793

Adverse event: Vision complaint related to comparison with earlier randomized treatment or habitual spectacles
Serious: no
Organ System: Eye disorders
Notes: Patients reporting blur at a particular viewing distance, not liking glasses as well as previous ones, or changing glasses wear behavior.
Frequency: 7 affected / 29 at risk

Adverse event: Vision complaint related to comparison with earlier randomized treatment or habitual spectacles
Serious: no
Organ System: Eye disorders
Notes: Patients reporting blur at a particular viewing distance, not liking glasses as well as previous ones, or changing glasses wear behavior.
Frequency: 1 affected / 30 at risk

Adverse event: Upper Respiratory Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reports of cough or runny nose
Frequency: 4 affected / 30 at risk

Adverse event: Vision complaint related to comparison with earlier randomized treatment or habitual spectacles
Serious: no
Organ System: Eye disorders
Notes: Patients reporting blur at a particular viewing distance, not liking glasses as well as previous ones, or changing glasses wear behavior.
Frequency: 2 affected / 30 at risk

Adverse event: Upper Respiratory Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reports of cough or runny nose
Frequency: 2 affected / 30 at risk
Study: NCT03367910

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT03368066

Adverse event: Liver-related death
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Death partially or completely attributed to patient's liver disease
Frequency: 24 affected / 100 at risk

Adverse event: Non-liver-related death
Serious: yes
Organ System: General disorders
Notes: Death not related to underlying liver disease
Frequency: 1 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient who experienced nausea after Cosyntropin administration, resolved with IV anti-emetic therapy
Frequency: 1 affected / 100 at risk