TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00470106

Adverse event: MRSA cellulitis in both hands.
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: 5150 hold for suicidal thinking, aggressive behavior and exessive use of alcohol
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: 5150 for threatening to sexually assault a female Veteran
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: ER visit for public intoxication.
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: 5150 hold for relapse using cocaine and alcohol
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Subject was hospitalized for 8 days due to an inflammed pancreas.
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk

Adverse event: 5150 hold for aggressive argument with his mother.
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk
Study: NCT00470158

Adverse event: infectious hospitalizations
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 201 at risk

Adverse event: noninfectious hospitalizations
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 201 at risk

Adverse event: infectious hospitalizations
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 199 at risk

Adverse event: noninfectious hospitalizations
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 199 at risk

Adverse event: infectious hospitalizations
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 201 at risk

Adverse event: infectious hospitalizations
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 198 at risk

Adverse event: noninfectious hospitalizations
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 198 at risk

Adverse event: infectious hospitalizations
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 201 at risk

Adverse event: noninfectious hospitalizations
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 201 at risk
Study: NCT00470262

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: unrelated to study medication
Frequency: 1 affected / 12 at risk
Study: NCT00470301

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 60 at risk
Study: NCT00470392

Adverse event: Exacerbation of non-target psoriasis plaques during washout of topical medications
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Grade 4 target site reaction - blistering post UVB
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Contact vs irritant dermatitis surrounding target sites secondary to bandages
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Grade 3 target site reaction - erythema with mild discomfort post UVB
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Exacerbation of psoriasis surrounding target sites secondary to bandages
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Burning sensation with use of study product
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Right knee trauma and pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Exacerbation of non-target psoriasis plaques during washout of topical medications
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Notes: evaluated and treated by the staff of the LSCVAMC Emergency Department
Frequency: 1 affected / 2 at risk
Study: NCT00470418

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 7 at risk

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperglycemic Lab Value
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Discomfort and Pain at Needle Injection Site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Hypoglycemic Lab Value
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Low Hemocrit Lab Value
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Patient had chronic anemia
Frequency: 1 affected / 7 at risk

Adverse event: Bleeding from Scratch on Arm
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 3 at risk
Study: NCT00470548

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Nasal Hemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 37 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Increased transaminases
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk
Study: NCT00470626

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Procedure or Device Related Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 death occured within 24 hours of device placement. Poor overall health likely contributed to death.

1 death occurred 185 days post-procedure and was the result of a pulmonary thromboembolism; the location of the origin of the clot was unknown.
Frequency: 2 affected / 129 at risk
Study: NCT00471068

Adverse event: Ocular pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Redness eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Inguinal hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: This SAE occurred while patient was in the run-in period taking timolol
Frequency: 1 affected / 25 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Ocular pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk
Study: NCT00471107

Adverse event: Thermal burn
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Punctate burn under reference electrode on arm
Frequency: 1 affected / 12 at risk
Study: NCT00471315

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 18 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 5 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 18 at risk
Study: NCT00471354

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 228 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 228 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 228 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 228 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 228 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 20 affected / 228 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 228 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 228 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 55 affected / 228 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 74 affected / 228 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 228 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 228 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 228 at risk
Study: NCT00471380

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

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 22 at risk

Adverse event: Sternal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not drug related
Frequency: 1 affected / 24 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not drug related
Frequency: 1 affected / 24 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 24 at risk
Study: NCT00471822

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9705 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 9705 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9705 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 117 affected / 9705 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9705 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9705 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9705 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 9705 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9705 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9705 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 9705 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 9705 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 9705 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 9705 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 9705 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 115 affected / 9705 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 9705 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 9705 at risk

Adverse event: Upper airway obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9705 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9705 at risk
Study: NCT00472030

Adverse event: Hospitalization for Congestive Heart Failure Exacerbation
Serious: yes
Organ System: Cardiac disorders
Notes: Subject with known history/treatment of Congestive Heart Failure and chronic obstructive pulmonary disease. ON 8/25/2008, subject experienced shortness of breath with hospitalization, deemed not related to study drug.
Frequency: 1 affected / 2 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject hospitalized for cellulitis at an outside hospital. Subject prescribed antibiotics for skin infection but did not take. Subsequent followup visit revealed Pemphigoid in the site Serious adverse event determined not to be related to study drug
Frequency: 1 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject presented with ankle edema at baseline. This was rated as mild, not related to study drug, no action was taken or required and this resolved without sequelae.
Frequency: 1 affected / 1 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject experienced pruritis at baseline. This was rated as moderately severe, unrelated to the study drug, was treated with concomitant medications and was continuing at the end of followup.
Frequency: 1 affected / 1 at risk

Adverse event: Staph Aureus Infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject was diagnosed with staph aureus infection which was cultured from a superficial skin erosion on the back. This was mild, unrelated to study drug, resolved without sequelae and was treated with concomitant medication.
Frequency: 1 affected / 1 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Notes: Subject was diagnosed with nasal stuffiness which was rated as mild in severity, was rated unlikely related to the study drug, was not treated and resolved without sequelae.
Frequency: 1 affected / 1 at risk

Adverse event: Cough associated Nasal Drainage
Serious: no
Organ System: General disorders
Notes: Subject experienced a cough associated with nasal drainage which was rated as mild in severity, not treated, resolved without sequelae and rated as unlikely to be related to the study drug use.
Frequency: 1 affected / 1 at risk

Adverse event: Staphylococcus infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject experienced a staphylococcus infection on the skin of the right toe. This was rated as mild in severity, resolved without sequelae, was rated unlikely to be related to study drug and required the use of concomitant medication.
Frequency: 1 affected / 1 at risk
Study: NCT00472043

Adverse event: Bile duct cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 33 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk
Study: NCT00472082

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2 at risk
Study: NCT00472108

Adverse event: Carotsid Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Superficial femoral artery to dorsalis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 32 at risk

Adverse event: Redden Ulcer and Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Abdominal aneuryse - ruptured
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: New malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 32 at risk
Study: NCT00472446

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk
Study: NCT00472576

Adverse event: Decreased Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 5 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 5 at risk

Adverse event: Difficulty falling asleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 5 at risk

Adverse event: Interrupted Sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 5 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Decreased Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 5 at risk

Adverse event: Muscle, bone, or joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Difficulty falling asleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 5 at risk

Adverse event: Interrupted Sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Terminal insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 5 at risk
Study: NCT00472641

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypomania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk