TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00177216

Adverse event: Skin irritation related to EEG electrode placement
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant reported some skin irritation at the site of electrode placement.
Frequency: 1 affected / 23 at risk

Adverse event: Collodian remover splashed in eye
Serious: no
Organ System: Eye disorders
Notes: During electrode removal, the collodian remover splashed into one of the participant's eyes.
Frequency: 1 affected / 23 at risk

Adverse event: Inpatient Hospitalization
Serious: yes
Organ System: Vascular disorders
Notes: Participant reported a hospitalization for hypertension
Frequency: 1 affected / 20 at risk
Study: NCT00177671

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 67 at risk

Adverse event: Myocardial infarcation with congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Death due to heart attack in person with history of coronary heart disease and hypertension.
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 63 at risk
Study: NCT00178256

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: community acquired pneumonia
Frequency: 1 affected / 41 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: pulmonary embolism
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Pathology showed this to be unrelated to the chemotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk
Study: NCT00178399

Adverse event: Pneumonitis/Pulmonary Infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 128 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 128 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 128 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 128 at risk
Study: NCT00178464

Adverse event: Fever resulting in Hospitalization
Serious: yes
Organ System: General disorders
Notes: may be in association w/another SAE
Frequency: 6 affected / 11 at risk

Adverse event: Severe Anemia resulting in hospitalization
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: may be assoc w/other SAEs.
Frequency: 1 affected / 11 at risk

Adverse event: Pneumonia resulting in hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vasoocclusive Crisis Pain resulting in hospitalization
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: May be assoc w/other SAEs.
Frequency: 2 affected / 11 at risk

Adverse event: Hypersplenism
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: May be associated w/other SAEs.
Frequency: 1 affected / 11 at risk

Adverse event: Asthma resulting in hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: May be assoc w/other SAEs.
Frequency: 1 affected / 11 at risk

Adverse event: Fracture resulting in hospitalization
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Acute Chest Syndrome resulting in hospitalization.
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abnormal MRA resulting in withdrawal from study.
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Scabies
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bleeding per rectum
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tarry stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk
Study: NCT00178620

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 253 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 37 at risk
Study: NCT00178646

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Visual Change
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: Altered Mental Status
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: Salivary hypersecretion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk
Study: NCT00178685

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 172 at risk

Adverse event: Dropped from study after patient quit smoking
Serious: no
Organ System: Social circumstances
Notes: Unable to locate specific adverse reaction/note from cardiology.Patient dropped from the study 2 weeks after being decreased to 2 -14 mg patches per day \& previously had quit smoking.
Frequency: 1 affected / 172 at risk

Adverse event: Patient had adverse event while being treated for MS. Unrelated to smoking study.
Serious: no
Organ System: General disorders
Notes: Patient was being treated for MS with SoluMedrol. Adverse event unrelated to smoking study.
Frequency: 1 affected / 172 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 324 at risk

Adverse event: Dropped from study after patient quit smoking
Serious: no
Organ System: Social circumstances
Notes: Unable to locate specific adverse reaction/note from cardiology.Patient dropped from the study 2 weeks after being decreased to 2 -14 mg patches per day \& previously had quit smoking.
Frequency: 1 affected / 324 at risk

Adverse event: Patient had adverse event while being treated for MS. Unrelated to smoking study.
Serious: no
Organ System: General disorders
Notes: Patient was being treated for MS with SoluMedrol. Adverse event unrelated to smoking study.
Frequency: 1 affected / 324 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 324 at risk
Study: NCT00178841

Adverse event: Hypertriglyceridemia and hypercholesterolemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypertriglyceridemia and hypercholesterolemia, two expected adverse events (AEs), were limited to grade 1 because of aggressive management using omega 3 fatty acids, long-acting niacin, fenofibrate, ezetimibe, and statins (N=4).
Frequency: 4 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: N=2 grade 3 neutropenia
Frequency: 3 affected / 4 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk
Study: NCT00179400

Adverse event: Hypotension
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Following clamp study, Blood Pressure (BP) 64/40, Heart Rate (HR) 88. Subject had no intake of oral fluids since 11p the night before study. Following infusion of 3 liters of intravenous fluid, subject was discharged in stable condition. BP 110/68.
Frequency: 1 affected / 16 at risk
Study: NCT00179413

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 282 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 282 at risk

Adverse event: Fatigue, asthenia
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 282 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Patients who met the primary endpoints of disease progression with liver failure, bleeding or liver cancer
Frequency: 53 affected / 282 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 242 affected / 282 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 282 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 267 at risk

Adverse event: Fatigue, asthenia
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 267 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Patients who met the primary endpoints of disease progression with liver failure, bleeding or liver cancer
Frequency: 59 affected / 267 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 267 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 267 at risk
Study: NCT00179959

Adverse event: Itching and Irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT00179998

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: child hospitalized for treatment of wheezing 4 months after starting Nebulized rhDNAse. Data is not available for the second period.
Frequency: 1 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough reported at any monthly assessment over 6 month study interval
Frequency: 11 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough reported at any monthly assessment over 6 month study interval
Frequency: 11 affected / 12 at risk
Study: NCT00180674

Adverse event: Minor haemorrhage
Serious: no
Organ System: General disorders
Notes: An episode of minor haemorrhage secondary to an episode of gingivitis, which resolved following antibiotics and did not require blood transfusion, but did require cessation of the anticoagulation for a short period of 2 days.
Frequency: 1 affected / 9 at risk
Study: NCT00180687

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of Nausea / vomiting episodes recorded in patient's chart
Frequency: 5 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of Nausea / vomiting episodes recorded in patient's chart
Frequency: 5 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of Nausea / vomiting episodes recorded in patient's chart
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of Nausea / vomiting episodes recorded in patient's chart
Frequency: 5 affected / 20 at risk
Study: NCT00180713

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Elevated Creatinine Kinase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk
Study: NCT00181610

Adverse event: Red marks
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Red marks
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Red marks
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT00181623

Adverse event: Tingling in hands
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Red marks at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT00181961

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

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

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

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

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

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

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

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

Adverse event: Thicker Menstrual Discharge
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk
Study: NCT00182078

Adverse event: Suicidal ideation. Tremors
Serious: no
Organ System: Psychiatric disorders
Notes: 1 subject in the sertraline arm was reported after discharge by his mother to have "tremors" and 1 incident of suicidal ideation(SI) when stressed with her. The tremors stopped after 1 week. No SI was present on evaluation, nor on followup.
Frequency: 1 affected / 17 at risk
Study: NCT00182637

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

Adverse event: Decrease Appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Insominia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain extremities, chest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: neuropathy extremities
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

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

Adverse event: chills / cough cold symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Body Aches / Flu Symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Sensitive skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk
Study: NCT00182728

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Low blood counts
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 71 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Congestive heart failure (CHF)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 71 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 71 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Infection with unknown ANC - Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Breast procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Changes in vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 71 at risk
Study: NCT00183170

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 193 at risk
Study: NCT00183196

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 50 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 39 affected / 50 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 50 at risk

Adverse event: Premature ejaculation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 39 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 50 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 29 affected / 50 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 50 at risk

Adverse event: Premature ejaculation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 50 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 31 affected / 50 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 50 at risk

Adverse event: Premature ejaculation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 40 at risk