TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01617577

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: all headaches occured after lumbar puncture regardless of GCSF or placebo treatment
Frequency: 1 affected / 8 at risk

Adverse event: generalized aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: relieved in all subjects with non-steroidal anti-inflammatory agents (tyelone or motrin)
Frequency: 2 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: all headaches occured after lumbar puncture regardless of GCSF or placebo treatment
Frequency: 1 affected / 8 at risk

Adverse event: generalized aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: relieved in all subjects with non-steroidal anti-inflammatory agents (tyelone or motrin)
Frequency: 5 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT01617603

Adverse event: Cyst resection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Resection of a papillary cyst in the bladder. Post study SAE, no relationship to the product.
Frequency: 1 affected / 20 at risk

Adverse event: Pacemaker installation
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia needing a pacemaker fitting
Frequency: 1 affected / 21 at risk
Study: NCT01618214

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 172 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Adenosquamous cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 172 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA15.1).
Frequency: 1 affected / 172 at risk

Adverse event: Meniere
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 172 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA15.1).
Frequency: 1 affected / 172 at risk

Adverse event: Heat stroke
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 172 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 172 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 172 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA15.1).
Frequency: 13 affected / 172 at risk
Study: NCT01618422

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 111 at risk
Study: NCT01618864

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild irritation with bumps or pimples on the cheeks
Frequency: 2 affected / 23 at risk
Study: NCT01618955

Adverse event: Exostosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk
Study: NCT01618968

Adverse event: Fatigue (10 mg Vibex MTX SC Thigh)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rheumatoid Arthritis (10 mg Vibex MTX SC Abdomen)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Sick Sinus Syndrome (15 mg Vibex MTX SC Thigh)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea (20 mg MTX Oral)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Myocardial Infarction (25 mg Vibex MTX SC Abdomen)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk
Study: NCT01619488

Adverse event: Band slippage, leading to removal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk
Study: NCT01619878

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cerebral malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 20 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 20 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk
Study: NCT01620047

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 20 at risk
Study: NCT01620060

Adverse event: Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Dystonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 105 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 105 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 105 at risk

Adverse event: Somnelence
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 105 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 105 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 105 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 105 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 105 at risk
Study: NCT01620086

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: headache following rTMS
Frequency: 3 affected / 13 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Ear and labyrinth disorders
Notes: subject reported sinus infection
Frequency: 1 affected / 13 at risk

Adverse event: left tooth pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: left tooth and jaw pain which resolved
Frequency: 1 affected / 13 at risk
Study: NCT01620138

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01620177

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

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: This AE was the result of wisdom teeth pain, and the participant subsequently had the teeth removed.
Frequency: 1 affected / 29 at risk

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

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Change in Status Perception
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Change in Status Perception
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Loss of Consciousness with IV Insertion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Disorientation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk
Study: NCT01620190

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 26 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 26 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk
Study: NCT01620593

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Increased Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Increased Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk
Study: NCT01621009

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 234 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 234 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 234 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 234 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 234 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 229 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 229 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 229 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 229 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 229 at risk
Study: NCT01621633

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk
Study: NCT01621776

Adverse event: Hypoglycemic Event
Serious: no
Organ System: Endocrine disorders
Notes: The participants have a diagnosis of diabetes. A hypoglycemic event is not an unusual occurrence for them to experience.
Frequency: 41 affected / 41 at risk

Adverse event: Hypoglycemic Event
Serious: no
Organ System: Endocrine disorders
Notes: The participants have a diagnosis of diabetes. A hypoglycemic event is not an unusual occurrence for them to experience.
Frequency: 40 affected / 40 at risk

Adverse event: Hypoglycemic Event
Serious: no
Organ System: Endocrine disorders
Notes: The participants have a diagnosis of diabetes. A hypoglycemic event is not an unusual occurrence for them to experience.
Frequency: 18 affected / 18 at risk
Study: NCT01621880

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 58 at risk

Adverse event: Fatigued
Serious: no
Organ System: General disorders
Frequency: 7 affected / 58 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 58 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 58 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 58 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 58 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 58 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 58 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 54 at risk

Adverse event: Fatigued
Serious: no
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 54 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 54 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 54 at risk

Adverse event: Gain weight
Serious: no
Organ System: General disorders
Frequency: 5 affected / 54 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 54 at risk
Study: NCT01621906

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk
Study: NCT01622231

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

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 61 at risk
Study: NCT01622257

Adverse event: Localized reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 66 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 66 at risk

Adverse event: Generalized malaise
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 66 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 66 at risk

Adverse event: Generalized malaise
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 66 at risk

Adverse event: Localized reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 66 at risk
Study: NCT01623154

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 2 affected / 99 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: cough
Frequency: 1 affected / 99 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dry Mouth
Frequency: 1 affected / 99 at risk

Adverse event: Acute Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Notes: Acute Upper Respiratory Infection
Frequency: 1 affected / 99 at risk
Study: NCT01623271

Adverse event: Expected Side Effects of Gralise
Serious: no
Organ System: General disorders
Notes: - Headache, nausea, dizziness, fatigue, increased joint pain
Frequency: 2 affected / 5 at risk
Study: NCT01623310

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 223 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 223 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 223 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 223 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 223 at risk

Adverse event: Intraocular Pressure Increase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 223 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 223 at risk

Adverse event: Spontaneously Reported Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 223 at risk

Adverse event: Nasal mucosal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 223 at risk

Adverse event: Nasal septum disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 223 at risk

Adverse event: Nasal septum ulceration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 223 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 223 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 223 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 223 at risk

Adverse event: Epistaxis Identified via Nasal Endoscopy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 223 at risk
Study: NCT01623323

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 705 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 705 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 705 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 705 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 705 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 102 affected / 705 at risk

Adverse event: Nasal mucosal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 72 affected / 705 at risk

Adverse event: Nasal Septal Disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 705 at risk