TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01027897

Adverse event: Lower gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to drug
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Not related to drug
Frequency: 1 affected / 30 at risk

Adverse event: Post operative wound
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: post operative wound infection. Not related to drug
Frequency: 1 affected / 30 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Not related to drug
Frequency: 2 affected / 30 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Doubtful if related to drug
Frequency: 1 affected / 30 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not related to drug
Frequency: 2 affected / 30 at risk
Study: NCT01027910

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: grade 3 or 4 neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 14 at risk
Study: NCT01028014

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Problem resolved after she took Diflucan that she had at home.
Frequency: 1 affected / 10 at risk

Adverse event: Voiding discomfort
Serious: no
Organ System: Renal and urinary disorders
Notes: Discomfort with voiding; improved with Azo-Standard.
Frequency: 1 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dry mouth resolved after the first two days of study medication.
Frequency: 1 affected / 10 at risk

Adverse event: Voiding discomfort
Serious: no
Organ System: Renal and urinary disorders
Notes: Discomfort with voiding; improved with Azo-Standard.
Frequency: 1 affected / 10 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Reported migraine like headaches over the weekend. Headaches stopped two days later. No further problems with headaches.
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Subject had mild nausea at bedtime after taking study medication. Instructed to take medication iwth food at dinner time and the problem was resolved.
Frequency: 1 affected / 10 at risk

Adverse event: Voiding discomfort
Serious: no
Organ System: Renal and urinary disorders
Notes: Discomfort with voiding; improved with Azo-Standard.
Frequency: 1 affected / 6 at risk
Study: NCT01028027

Adverse event: Increased IOP
Serious: no
Organ System: Eye disorders
Notes: Overall IOP change from baseline \>5mmHg
Frequency: 16 affected / 177 at risk

Adverse event: Increased IOP
Serious: no
Organ System: Eye disorders
Notes: Overall IOP change from baseline \>5mmHg
Frequency: 36 affected / 177 at risk
Study: NCT01028053

Adverse event: Anaphylactoid reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 232 at risk
Study: NCT01028300

Adverse event: Non-infected seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain-abdomen
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT01028352

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk
Study: NCT01028378

Adverse event: BSCVA loss of 2 or more lines
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 195 at risk

Adverse event: Retinal Detachments
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 195 at risk
Study: NCT01028391

Adverse event: All Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Coronary artery insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: All Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 164 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 164 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: All Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: All Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 164 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 164 at risk

Adverse event: All Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 153 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: All Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: All Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 153 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 153 at risk
Study: NCT01028560

Adverse event: Asthma related hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: asthma exacerbation requiring hospitalization
Frequency: 7 affected / 23 at risk

Adverse event: Cellulitis/skin abscess/infected insect bite
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 23 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Asthma related hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: asthma exacerbation requiring hospitalization
Frequency: 6 affected / 27 at risk

Adverse event: Cellulitis/skin abscess/infected insect bite
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Local allergic reaction after immunotherapy injectionss
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 22 of 27 (81%): erythema or induration or edema of ≤ 2.5 cm in diameter) 2 of 27 (7%): erythema or induration or edema of \> 2.5 cm in diameter but \< 50% surface area of upper arm 9 of 27 (33%): mild delayed local reaction
Frequency: 22 affected / 27 at risk

Adverse event: Systemic allergic reactions after immunotherapy injections
Serious: no
Organ System: Immune system disorders
Notes: Systemic reactions were defined as immediate if occurring within 2 hours after injections and delayed if between 2-48 hours after allergy immunotherapy.
Frequency: 12 affected / 27 at risk
Study: NCT01028677

Adverse event: low blood pressure due to blood-draw
Serious: no
Organ System: Vascular disorders
Notes: This subject experienced a drop in blood pressure (79/43) and heart rate (46) during the blood draw for the baseline visit. Subject was given breakfast and felt better after a few minutes and blood pressure/heart rate returned to normal.
Frequency: 1 affected / 10 at risk
Study: NCT01028716

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Rehospitalization for acute hypoxemic respiratory failure
Frequency: 1 affected / 45 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Worsening dyspnea with drop in EF to 35%
Frequency: 1 affected / 45 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: DAH requiring intubation and ICU admission. Resulted in Death.
Frequency: 1 affected / 45 at risk

Adverse event: Acute hypoxemia respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Notes: including arrythmia
Frequency: 13 affected / 45 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Including episodes of febrile neutropenia, infections and viral reactivations with BK and CMV in the blood.
Frequency: 42 affected / 45 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 45 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 45 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 45 at risk

Adverse event: GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 45 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 45 at risk

Adverse event: Derm
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 45 at risk
Study: NCT01028820

Adverse event: Anxiety
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 13 at risk

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

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

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 13 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 13 at risk

Adverse event: Increased Sleep
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 13 at risk
Study: NCT01028846

Adverse event: Mild Hypoglycemia (Asymptomatic)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1. During the observation period following the pancreatic clamp, a glucose level was noted to be 56 mg/dL. Dextrose subsequently infused and rapidly brought glucose levels to within normal limits. Subject remained asymptomatic.
Frequency: 1 affected / 10 at risk
Study: NCT01028911

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

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

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

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

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

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 7 at risk

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

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

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

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT01029002

Adverse event: Cardiac Hospitalization and ED Visits
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 36 at risk

Adverse event: Non-cardiac Hospitalization and ED Visits
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 36 at risk

Adverse event: Cardiac Hospitalization and ED Visits
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 38 at risk

Adverse event: Non-cardiac Hospitalization and ED Visits
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 38 at risk
Study: NCT01029535

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 103 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 103 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 103 at risk

Adverse event: Swelling face
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 99 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 99 at risk
Study: NCT01029587

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

Adverse event: Anticoagulation drug level below therapeutic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk
Study: NCT01029691

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: pre-existing severe fetal growth restrictions involved in both cases; IRB approved determination that these are unrelated to study participation or intervention. Neonatal deaths not tracked in standard of care arm
Frequency: 2 affected / 36 at risk

Adverse event: medical abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: severe growth restriction of fetus with no interval growth on serial ultrasounds as well as oligohydramnios
Frequency: 1 affected / 77 at risk
Study: NCT01029782

Adverse event: Vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 102 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk
Study: NCT01029795

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Infectious mononucleosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

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

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk
Study: NCT01029912

Adverse event: Discomfort from stimulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Discomfort from stimulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT01029925

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 7 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: lower extremity edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

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

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

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

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

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

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: disequilibrium
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

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

Adverse event: elevated AST
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

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

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

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