TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00152763

Adverse event: Deaths
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 77 at risk

Adverse event: Deaths
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Deaths
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Deaths
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 77 at risk
Study: NCT00153543

Adverse event: any arm pain in injected arm
Serious: no
Organ System: General disorders
Notes: pain in the subject's arm where they received the vaccine injection
Frequency: 20 affected / 28 at risk

Adverse event: any redness at injection site
Serious: no
Organ System: General disorders
Notes: redness in the subject's arm where they received the vaccine injection
Frequency: 2 affected / 28 at risk

Adverse event: any swelling at injection site
Serious: no
Organ System: General disorders
Notes: swelling in the subject's arm where they received the vaccine injection
Frequency: 6 affected / 28 at risk

Adverse event: any arm pain in injected arm
Serious: no
Organ System: General disorders
Notes: pain in the subject's arm where they received the vaccine injection
Frequency: 26 affected / 29 at risk

Adverse event: any redness at injection site
Serious: no
Organ System: General disorders
Notes: redness in the subject's arm where they received the vaccine injection
Frequency: 10 affected / 29 at risk

Adverse event: any swelling at injection site
Serious: no
Organ System: General disorders
Notes: swelling in the subject's arm where they received the vaccine injection
Frequency: 20 affected / 29 at risk

Adverse event: any arm pain in injected arm
Serious: no
Organ System: General disorders
Notes: pain in the subject's arm where they received the vaccine injection
Frequency: 27 affected / 29 at risk

Adverse event: any redness at injection site
Serious: no
Organ System: General disorders
Notes: redness in the subject's arm where they received the vaccine injection
Frequency: 7 affected / 29 at risk

Adverse event: any swelling at injection site
Serious: no
Organ System: General disorders
Notes: swelling in the subject's arm where they received the vaccine injection
Frequency: 17 affected / 29 at risk
Study: NCT00153842

Adverse event: Myelosuppression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk
Study: NCT00153985

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk
Study: NCT00156247

Adverse event: retinoid dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: dry/chapped lips
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk
Study: NCT00156390

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 110 at risk

Adverse event: Heart Failure Hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 110 at risk

Adverse event: Device infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 110 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: LV lead dislodgement
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 110 at risk

Adverse event: coronary sinus staining during venography
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: diaphragmatic stimulation from LV pacing requiring device reprogramming
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 110 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 77 at risk

Adverse event: Heart Failure Hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 77 at risk

Adverse event: Device infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: LV lead dislodgement
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 77 at risk

Adverse event: Atrial Lead Dislodgement
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: coronary sinus staining during venography
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: diaphragmatic stimulation from LV pacing requiring device reprogramming
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 77 at risk
Study: NCT00156715

Adverse event: Increased Psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Lump in Breast
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Could not obtain biopsy results
Frequency: 1 affected / 16 at risk

Adverse event: Suicidal Ideation/Attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Increased Appetite/Weight Gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 16 at risk

Adverse event: Gi Distress/Poor Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Cold or Flu Symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Unusual Dream Activity
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 16 at risk

Adverse event: Heaviness/Pressure
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Palpatations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk
Study: NCT00157755

Adverse event: Apnoeic attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Central venous catheterisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 55 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: High lead impedance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Implant site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Lead migration/dislodgment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Lead impedance NOS or high lead impedance
Serious: no
Organ System: General disorders
Frequency: 11 affected / 55 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Lead migration/dislodgment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Lead impedance NOS or high lead impedance
Serious: no
Organ System: General disorders
Frequency: 6 affected / 32 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk
Study: NCT00157820

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 111 at risk

Adverse event: Invasive interventions
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 111 at risk

Adverse event: Hospitalization or prolongued hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 111 at risk

Adverse event: Innapropiate shocks
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 111 at risk

Adverse event: Sustain Symptomatic AT
Serious: no
Organ System: Cardiac disorders
Notes: sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention
Frequency: 5 affected / 111 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 223 at risk

Adverse event: Invasive interventions
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 223 at risk

Adverse event: Hospitalization or prolongued hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 223 at risk

Adverse event: Innapropiate shocks
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 223 at risk

Adverse event: Sustain Symptomatic AT
Serious: no
Organ System: Cardiac disorders
Notes: sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention
Frequency: 4 affected / 223 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 223 at risk

Adverse event: Invasive interventions
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 223 at risk

Adverse event: Hospitalization or prolongued hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 36 affected / 223 at risk

Adverse event: Innapropiate shocks
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 223 at risk

Adverse event: Sustain Symptomatic AT
Serious: no
Organ System: Cardiac disorders
Notes: sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention
Frequency: 1 affected / 223 at risk
Study: NCT00157950

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 27 affected / 117 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 85 affected / 117 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 33 affected / 117 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 117 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 117 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 117 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 59 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 59 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 59 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 59 at risk
Study: NCT00158184

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Occurred after admission but prior to oral oxycodone being given.
Frequency: 2 affected / 16 at risk
Study: NCT00158223

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

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: withdrew consent
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 28 at risk

Adverse event: Severe EPS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Delirium
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: exacerbation of hemorrhoidal bleeding
Frequency: 1 affected / 25 at risk
Study: NCT00158249

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

Adverse event: NAusea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT00158379

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Suspected thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 105 at risk

Adverse event: deterioration of general condition
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 105 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 105 affected / 105 at risk
Study: NCT00158743

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

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

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

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Uterine atony
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 27 at risk
Study: NCT00159250

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

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Bilateral oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Decline in cardiac function
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Bilateral erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 5 at risk

Adverse event: Myoglobinuria
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 5 at risk
Study: NCT00159419

Adverse event: Acute phase reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 9 at risk
Study: NCT00159588

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 19 at risk
Study: NCT00159861

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Increased tendency to bruise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk
Study: NCT00159965

Adverse event: tiredness/ sleepiness
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events profile and symptoms checklist
Frequency: 1 affected / 19 at risk

Adverse event: tiredness/ sleepiness
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events profile and symptoms checklist
Frequency: 4 affected / 19 at risk
Study: NCT00160654

Adverse event: Bicytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 251 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 251 at risk

Adverse event: Coordination abnormal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 251 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 251 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 251 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 251 at risk

Adverse event: Anger
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 251 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 251 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 251 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 251 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 251 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 251 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 251 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 251 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 251 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 251 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 251 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 75 affected / 251 at risk