TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01065558

Adverse event: Flank pain
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient reported flank pain which was caused by a kidney stone. Investigator defined as not drug related, and resolved without incident. Patient received all doses and was not removed from study.
Frequency: 1 affected / 5 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Patient developed respiratory infection (pneumonia)following the trial. Investigator reported this as not related to ecopipam administration. Patient was briefly hosptialized and infection resolved.
Frequency: 1 affected / 5 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk
Study: NCT01065597

Adverse event: Induced seizure
Serious: no
Organ System: Nervous system disorders
Notes: These 3 subjects had electrically induced seizure despite aim to avoid this by using a lower dose of electricity.
Frequency: 3 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Anxiety dream
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT01065766

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4033 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Chronic hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4033 at risk

Adverse event: Hyperlipidaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4033 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Tension headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4033 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4033 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4033 at risk
Study: NCT01065818

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abnormal Liver Function
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abnormal Complete Blood Count (CBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Blood Glucose Level Increased
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 5 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 5 at risk

Adverse event: White Blood Cell (WBC) Count Increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk
Study: NCT01065844

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 1 affected / 15 at risk

Adverse event: dizziness, grade 3
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking.

Grade: Severe - limiting activities of daily life
Frequency: 1 affected / 15 at risk

Adverse event: hyponatremia, grade 4
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.
Frequency: 1 affected / 15 at risk

Adverse event: Investigations - Other, liver enzymes increased, grade 3
Serious: no
Organ System: Investigations
Notes: Marked elevations across liver function tests considered severe (grade 3)
Frequency: 2 affected / 15 at risk
Study: NCT01066000

Adverse event: Decrease of state awareness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Cardiovascular event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Decrease of state of awareness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Haemorrhoid
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Acute myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Cardiovascular event
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Menstruate
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 33 at risk

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

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 33 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk
Study: NCT01066052

Adverse event: Urethral reflux
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Trauma leading to scalp surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Measles
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Serious otitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Immunoglobulin G4 deficiency
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Chronic persistent cytolysis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 61 at risk

Adverse event: Surgery to remove large mass (meningocele/benign cyst)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Transtympanic drainage tube placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Tonsillectomy/adenoidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 61 at risk
Study: NCT01066104

Adverse event: Bilateral hilar adenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT01066364

Adverse event: Severe hot flashes with leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: IBD Exacerbation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Muscle ache with elevated CPK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk
Study: NCT01066520

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 152 at risk

Adverse event: Hypoasthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Oropharingeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 152 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 152 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 148 at risk

Adverse event: Nasopharingitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 148 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 148 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 148 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 148 at risk

Adverse event: Oropharingeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 148 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 148 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 148 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 147 at risk

Adverse event: Nasopharingitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 147 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 147 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Oropharingeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 147 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 147 at risk
Study: NCT01066546

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk
Study: NCT01066897

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: restless leg
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: odd thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk
Study: NCT01067326

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Irritated bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT01067456

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk
Study: NCT01067469

Adverse event: CNS Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vessel injury - artery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Perforation, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 36 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: ALT/SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 36 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 36 at risk

Adverse event: AST/SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 36 at risk

Adverse event: CNS Hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Muscle weakness - generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Mental status change
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Thrombus, embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 35 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 35 at risk

Adverse event: ALT/SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 35 at risk

Adverse event: AST/SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 35 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk
Study: NCT01067508

Adverse event: Cardiovascular Health
Serious: no
Organ System: Cardiac disorders
Notes: One subject was withdrawn by the investigator concerning her cardiovascular health (not specified).
Frequency: 1 affected / 9 at risk
Study: NCT01067716

Adverse event: Elevated IOP (temporary)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 57 at risk

Adverse event: Photic phenomena (i.e., halos, glare, starbursts)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 57 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 57 at risk

Adverse event: Peripheral infiltrates
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 57 at risk

Adverse event: Other - cold/flu
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Decrease in BSCVA of greater than or equal to two lines
Serious: yes
Organ System: Eye disorders
Notes: Loss of greater than or equal to two lines of BSCVA is an SAE in the context of this study.
Frequency: 1 affected / 13 at risk

Adverse event: Inadvertent insallation of Tropicamide instead of Tetracaine
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Photic phenomena (i.e., halos, glare, starbursts)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 13 at risk

Adverse event: Corneal opacity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 13 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Superficial epithelial linear laceration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Other - hairline ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk
Study: NCT01067846

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant reported infrequent coughing. Physician determined it was not study related.
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Participant reported mild headaches. Physician determined it was not study related.
Frequency: 1 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Participant reported a nauseas feeling. Physician determined it was not study related.
Frequency: 1 affected / 29 at risk

Adverse event: sensation on skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant reported a crawling sensation on skin. Physician determined it was not study related.
Frequency: 1 affected / 30 at risk

Adverse event: rash on skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant reported a rash on skin. Physician determined it was not study related.
Frequency: 1 affected / 30 at risk
Study: NCT01067976

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 426 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 426 at risk
Study: NCT01068626

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk