TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00475332

Adverse event: Infection with grade 4 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Grade 4 leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Grade 4 lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Grade 4 neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Grade 3 Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: anemia grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: grade 1 low platelet
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: grade 1 lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT00475501

Adverse event: Osteitis deformans
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: surgery for pre-existing heart condition
Serious: yes
Organ System: Cardiac disorders
Notes: Subject had a pre-existing heart condition that did not preclude participation and thought that he might have surgery after the study. it was then decided to schedule the surgery sooner, so participation in the study stopped.
Frequency: 1 affected / 14 at risk

Adverse event: urinary symptoms
Serious: no
Organ System: General disorders
Notes: urinary symptoms defined as an increased score on urinary symptom questionaire
Frequency: 1 affected / 14 at risk

Adverse event: elevated hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: elevated hematocrit was defined as 54 or greater
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: elevated prostate specific antigen
Serious: no
Organ System: General disorders
Notes: elevate PSA was defined as 2.6 or greater for study purposes
Frequency: 1 affected / 13 at risk

Adverse event: elevated prostate specific antigen
Serious: no
Organ System: General disorders
Notes: elevate PSA was defined as 2.6 or greater for study purposes
Frequency: 1 affected / 17 at risk

Adverse event: urinary symptoms
Serious: no
Organ System: General disorders
Notes: urinary symptoms defined as an increased score on urinary symptom questionaire
Frequency: 1 affected / 17 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: 83-year old subject did not show up for visits. We learned from the newspaper that he had dies, but did not learn the cause of death.
Frequency: 1 affected / 16 at risk
Study: NCT00475540

Adverse event: Surgery/reoperation for mesh exposure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Reoperation for mesh related complication, exposure
Frequency: 5 affected / 32 at risk

Adverse event: suture exposure
Serious: no
Organ System: Surgical and medical procedures
Notes: Gore-tex suture exposure
Frequency: 5 affected / 33 at risk
Study: NCT00475657

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Blood creatine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 5 at risk
Study: NCT00475709

Adverse event: Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 40 affected / 1014 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 96 affected / 1014 at risk

Adverse event: Non-structural dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1014 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1014 at risk

Adverse event: Structural deterioration
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1014 at risk

Adverse event: Reoperation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1014 at risk

Adverse event: Valve related Mortality
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1014 at risk
Study: NCT00475722

Adverse event: various minor conditions
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 61 at risk

Adverse event: Surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: bowel obstruction
Frequency: 1 affected / 59 at risk

Adverse event: bipolar relapse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: various minor conditions
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 59 at risk
Study: NCT00475787

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Patient was diagnosed with spondylotic myelopathy
Frequency: 1 affected / 69 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac related syncope, not related to study
Frequency: 2 affected / 69 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient fell on ice and injured lower back and neck
Frequency: 1 affected / 69 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated chest pain
Frequency: 1 affected / 69 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 25 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 69 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 69 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated MI
Frequency: 1 affected / 67 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 67 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 67 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 67 at risk
Study: NCT00475878

Adverse event: increasing clinical symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 75 at risk
Study: NCT00475904

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 140 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 144 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 76 at risk
Study: NCT00476008

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

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

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

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

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

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

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

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk
Study: NCT00476021

Adverse event: Death
Serious: yes
Organ System: Social circumstances
Notes: One participant died as a result of unrelated causes
Frequency: 1 affected / 51 at risk

Adverse event: Vulvovaginal injury
Serious: no
Organ System: Reproductive system and breast disorders
Notes: a participant who underwent a postplacental insertion experienced a vaginal laceration when the IUD strings were cut with scissors, requiring repair with suture
Frequency: 1 affected / 51 at risk

Adverse event: retained IUD insertion tube
Serious: no
Organ System: Reproductive system and breast disorders
Notes: IUD insertion tube appeared to have detached from the IUD inserter and had been left inside her uterus during the postplacental IUD placement. Tihs was considered a complete expulsion for the analysis
Frequency: 1 affected / 51 at risk

Adverse event: malpositioned IUD
Serious: no
Organ System: Reproductive system and breast disorders
Notes: IUD was positioned obliquely in the uterus with the arms of the IUD against the right uterine wall and the base of the IUD in the left cornua. Participant was asymptomatic.
Frequency: 1 affected / 51 at risk
Study: NCT00476047

Adverse event: Anemia Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neutropenia Grade 3 or 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 16 at risk

Adverse event: Thrombocytopenia Grade 3 or 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 16 at risk
Study: NCT00476242

Adverse event: Psychiatric worsening
Serious: yes
Organ System: Psychiatric disorders
Notes: The participant attended two outpatient visits, and was removed from the study due to psychiatric worsening (irritability, insomnia, and disorganized thinking).
Frequency: 1 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 28 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 28 at risk

Adverse event: Increased/decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 28 at risk

Adverse event: Fatigue/drowsiness
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 28 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 28 at risk

Adverse event: Body Aches
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 28 at risk

Adverse event: GI Distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 28 at risk

Adverse event: Sweating/chills
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 28 at risk

Adverse event: Faintness/dizziness
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 27 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 27 at risk

Adverse event: Increased/decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 27 at risk

Adverse event: Fatigue/drowsiness
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 27 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 27 at risk

Adverse event: Body Aches
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 27 at risk

Adverse event: GI Distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 27 at risk

Adverse event: Sweating/chills
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 27 at risk

Adverse event: Faintness/dizziness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 27 at risk
Study: NCT00476645

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin and subcutaneous tissue disorders - Edema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Skin and subcutaneous tissue disorders - Intermittent tiny sensitive area on forehead (sligh
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT00476957

Adverse event: MACCE (major adverse cardiac and cerebrovascular event
Serious: yes
Organ System: Cardiac disorders
Frequency: 579 affected / 4357 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 201 affected / 4357 at risk

Adverse event: MACCE (major adverse cardiac and cerebrovascular event
Serious: yes
Organ System: Cardiac disorders
Frequency: 507 affected / 4352 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 184 affected / 4352 at risk
Study: NCT00477087

Adverse event: Haematuria
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pancytopenic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Progressive disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Death due to progressive disease
Frequency: 1 affected / 10 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Night sweats
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT00477152

Adverse event: Infusion site cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to HYLENEX
Frequency: 1 affected / 51 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 44 affected / 51 at risk

Adverse event: Infusion site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 46 affected / 51 at risk

Adverse event: Infusion site rash
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 51 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk
Study: NCT00477165

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: decreased energy
Frequency: 3 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 27 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: pregnancy despite birth control
Frequency: 1 affected / 27 at risk
Study: NCT00477191

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

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

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

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal 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: NCT00477230

Adverse event: Mechanical Perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 32 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Diaphragmatic paralysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Chest pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 32 at risk

Adverse event: Medication Intolerance
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 32 at risk