TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00942994

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 202 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 209 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 209 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 209 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 209 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 209 at risk
Study: NCT00943098

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 12 affected / 70 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 70 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 70 at risk

Adverse event: Alveolar osteitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 72 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 72 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 72 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 8 affected / 72 at risk

Adverse event: Alveolar osteitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 72 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 72 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 72 at risk
Study: NCT00943150

Adverse event: Extended drainage period
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Seroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk
Study: NCT00943319

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Mental Status change
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk
Study: NCT00943579

Adverse event: Changes in bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 5 affected / 21 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Increased irritability in a variety of settings
Frequency: 3 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Persistent changes in sleep, including onset insomnia, frequent wakening during the night, lightening of sleep
Frequency: 6 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Viral or autoimmune rash
Frequency: 1 affected / 21 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Notes: Persistent increase in overall activity level in a variety of settings
Frequency: 3 affected / 21 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Increase in anxious symptoms
Frequency: 2 affected / 21 at risk

Adverse event: Repetitive Behaviors
Serious: no
Organ System: Nervous system disorders
Notes: Sustained changes in or appearance of stereotypies or other odd, repetitive behaviors
Frequency: 3 affected / 21 at risk

Adverse event: Changes in bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 5 affected / 20 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Increased irritability in a variety of settings
Frequency: 4 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Persistent changes in sleep, including onset insomnia, frequent wakening during the night, lightening of sleep
Frequency: 5 affected / 20 at risk

Adverse event: Repetitive Behaviors
Serious: no
Organ System: Nervous system disorders
Notes: Sustained changes in or appearance of stereotypies or other odd, repetitive behaviors
Frequency: 5 affected / 20 at risk
Study: NCT00943592

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 82 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 82 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 16 affected / 82 at risk

Adverse event: Hepatobiliary disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 30 affected / 82 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hepatobiliary disease
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 48 affected / 82 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 82 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 82 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Renal disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 82 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Idiopathic intracranial hypertension
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk
Study: NCT00943605

Adverse event: Seroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 30 at risk

Adverse event: Fluid aspiration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Incision opened and resutured
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Seroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Fluid aspiration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk
Study: NCT00943787

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 34 at risk

Adverse event: Vasovagal Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Lower Back Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Abdomen ecchymosis near Guardian site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk
Study: NCT00943800

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 87 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Epstein-Barr virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 87 at risk

Adverse event: Oesophageal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 87 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 87 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 87 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 87 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 87 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 87 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 87 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 87 at risk
Study: NCT00943852

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 11 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 12 at risk
Study: NCT00944450

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 12 at risk

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

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

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk
Study: NCT00944658

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

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

Adverse event: Diarrhoe
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

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

Adverse event: Flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: raised serum amylase
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Diarrhoe
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk
Study: NCT00944671

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 24 at risk

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

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

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

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk
Study: NCT00944710

Adverse event: Light Sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: New ocular deviation or worsening of preexisting deviation by at least 10 PD
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 40 at risk

Adverse event: Light Sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 33 at risk

Adverse event: New ocular deviation or worsening of preexisting deviation by at least 10 PD
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk
Study: NCT00944749

Adverse event: Hospitalization - Neutropenic fever
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 23 at risk

Adverse event: Hospitalization - Infection/ Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Hospitalization - Hemorrhage/ bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death - Hemorrhage/ bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hospitalization - Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 23 at risk

Adverse event: Hospitalization - Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk
Study: NCT00945035

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk
Study: NCT00945100

Adverse event: New ocular deviation or worsening of preexisting deviation by at least 10 pd
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 83 at risk

Adverse event: New ocular deviation or worsening of preexisting deviation by at least 10 pd
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 86 at risk
Study: NCT00945243

Adverse event: Pain and/or Weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Adjacent Level Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 11 at risk
Study: NCT00945256

Adverse event: Redness at biopsy site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Swelling at femoral catheter site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: The subject developed cellulitis near the placement of the femoral catheters 3 days post procedure.
Frequency: 1 affected / 16 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain in direct relation to infusion of Definity Microbubbles
Frequency: 1 affected / 16 at risk
Study: NCT00945282

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

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

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk