TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00582894

Adverse event: Intracranial hemorrhage - recurrence
Serious: yes
Organ System: Vascular disorders
Notes: Event determined to be "not related" to study participation; resulted in death of participant
Frequency: 1 affected / 17 at risk

Adverse event: Positive Cytomegalovirus cultures
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hospitalized for treatment and recovered without sequelae
Frequency: 1 affected / 17 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hospitalized and recovered without sequelae
Frequency: 1 affected / 17 at risk

Adverse event: Blasts in bone marrow
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Determined to be not related to study participation; recovered without sequelae
Frequency: 1 affected / 17 at risk

Adverse event: Syncopal episode / Hypotension
Serious: no
Organ System: General disorders
Notes: Determined to be "not related" to study participation; recovered without sequelae
Frequency: 1 affected / 17 at risk
Study: NCT00582998

Adverse event: Adverse event
Serious: no
Organ System: Infections and infestations
Notes: Post operative infection noted
Frequency: 23 affected / 119 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Frequency: 20 affected / 119 at risk

Adverse event: Adverse event
Serious: no
Organ System: Infections and infestations
Notes: Post operative infection noted
Frequency: 14 affected / 130 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Frequency: 12 affected / 130 at risk
Study: NCT00583024

Adverse event: Pulmonary emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Obstruction/stenosis of airway - Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 32 at risk

Adverse event: Cold and flu symptoms
Serious: no
Organ System: General disorders
Frequency: 5 affected / 32 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk
Study: NCT00583050

Adverse event: Aneurysm Rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 1366 at risk

Adverse event: Aneurysm size increase
Serious: no
Organ System: Vascular disorders
Frequency: 68 affected / 1366 at risk
Study: NCT00583115

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk
Study: NCT00583219

Adverse event: Pelvic soreness in first 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Positional light-headedness in first 24 hours
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anxiety in first 24 hours
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Bladder spasms in first 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Urethral discomfort in first 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dysuria in first 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Urinary tract infection after 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 25 at risk

Adverse event: Perineal rash 7 days after injection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Throbbing with urination 7 days after injection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dysuria after 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 25 at risk

Adverse event: Bladder spasms after 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Urethral discomfort after 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pelvic tenderness after 24 hours
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk
Study: NCT00583349

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Systemic Absorption of Drug
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 subject had detectable systemic absorption of the drug after 1 instillation of the 450 mg dose (level 16 ng/ml). Instillation was delayed by 1 week, after which serum levels returned to undetectable and remained so for the remainder of treatment.
Frequency: 1 affected / 3 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk
Study: NCT00583414

Adverse event: Aneurysm Growth
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 401 at risk

Adverse event: Aneurysm Growth
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 401 at risk
Study: NCT00583453

Adverse event: Vomiting, grade 1
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting, grade 1
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
Frequency: 2 affected / 6 at risk

Adverse event: Dehydration, grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or lack of adequate fluid intake.

Grade 2: I.V. fluids indicated for less than 24 hours
Frequency: 2 affected / 6 at risk

Adverse event: Dysphagia, grade 2
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by difficulty in swallowing. Grade 2 = symptomatic and altered eating / swallowing
Frequency: 1 affected / 6 at risk
Study: NCT00583492

Adverse event: Influenza like illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 21 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Increased SGOT/SGPT
Frequency: 11 affected / 21 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low neutrophil counts
Frequency: 7 affected / 21 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low platelets
Frequency: 10 affected / 21 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Increased SGOT/SGPT
Frequency: 2 affected / 23 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low neutrophil counts
Frequency: 1 affected / 23 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low platelets
Frequency: 3 affected / 23 at risk
Study: NCT00583596

Adverse event: Obstruction of Pulmonary Artery with Gradient
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Mitral Valve regurgitation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Left Pulmonary artery stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Aortic Stenosis with Chest Pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 1 affected / 436 at risk

Adverse event: Atrial ectopic beats
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Echo finding
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Diabetic ketoacidosis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 436 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 436 at risk
Study: NCT00583622

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 12 at risk

Adverse event: Elevated Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Enterococcus Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 12 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 12 at risk

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

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk
Study: NCT00583661

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 22 affected / 48 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 48 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 48 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 48 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 48 at risk

Adverse event: Neurological Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 48 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 48 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 48 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 48 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 48 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk
Study: NCT00583713

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Symptomatic hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 6 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abnormal urinalysis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk
Study: NCT00583804

Adverse event: Device infection
Serious: no
Organ System: Infections and infestations
Notes: Device infection requiring removal of some or all of implanted components.
Frequency: 2 affected / 10 at risk
Study: NCT00584415

Adverse event: serious
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 119 at risk

Adverse event: pericardial effusion/tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 119 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Phrenic nerve injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 119 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 119 at risk
Study: NCT00584454

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

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

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

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

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

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

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

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

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

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT00584480

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Likely not related to HBOt treatment. Only ear pain, increased fatigue, dehydration, and increased mouthing of objects were judged to be likely related to the HBOT treatment.
Frequency: 1 affected / 10 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 10 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 10 at risk
Study: NCT00584558

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac Tamponade 3%
Frequency: 72 affected / 2420 at risk

Adverse event: IVC thrombus
Serious: no
Organ System: Vascular disorders
Notes: IVC thrombus
Frequency: 24 affected / 2420 at risk
Study: NCT00584857

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 30 at risk

Adverse event: port fracture
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk
Study: NCT00584909

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 9 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk
Study: NCT00584922

Adverse event: Esophageal erythema
Serious: yes
Organ System: Gastrointestinal disorders
Notes: by endoscopy
Frequency: 1 affected / 171 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: by endoscopy
Frequency: 12 affected / 171 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: By endoscopy
Frequency: 4 affected / 171 at risk
Study: NCT00584948

Adverse event: Road traffic accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: One participant was badly injured in a motor vehicle accident and withdrew from the study
Frequency: 1 affected / 47 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One participant was diagnosed with terminal lung cancer and withdrew from the study
Frequency: 1 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 47 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: One participant was diagnosed with ovarian cancer and withdrew from the study
Frequency: 1 affected / 47 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One participant was diagnosed with pneumonia and withdrew from the study
Frequency: 1 affected / 47 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One participant had acute appendicitis and required an appendectomy, and withdrew from the study
Frequency: 1 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk