TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00439673

Adverse event: Perineal infiltration
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Bronchopneumonic outbreak
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Hemorragic shock
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Right pleuropneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Local inflamation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Sedation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Fever in neutropenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 62 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Broncopneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Inflammatory bowel
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Bowel abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Right lung pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hyperpyrexia and hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Confusion and disorientation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Somnolence and obtundation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Head and facial contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk
Study: NCT00440050

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 164 at risk

Adverse event: deep venous thrombosis/pulmonary embolus
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 164 at risk

Adverse event: other
Serious: yes
Organ System: General disorders
Frequency: 44 affected / 164 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 164 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 164 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 33 affected / 164 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 164 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 164 at risk

Adverse event: other
Serious: no
Organ System: General disorders
Frequency: 88 affected / 164 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 214 at risk

Adverse event: deep venous thrombosis/pulmonary embolus
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 214 at risk

Adverse event: other
Serious: yes
Organ System: General disorders
Frequency: 57 affected / 214 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 238 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 238 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 42 affected / 238 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 238 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 238 at risk

Adverse event: other
Serious: no
Organ System: General disorders
Frequency: 119 affected / 238 at risk
Study: NCT00440180

Adverse event: Increased Liver Enzymes
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Increased Liver Enzymes
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk
Study: NCT00440232

Adverse event: sleepiness/fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea (may be secondary to study medication or associated symptom of migraine)
Frequency: 3 affected / 36 at risk

Adverse event: sleepiness/fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk
Study: NCT00440700

Adverse event: Self-extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 122 at risk

Adverse event: Seizure activity
Serious: yes
Organ System: Nervous system disorders
Notes: seizure activity noted in patient after ICU admission for stroke
Frequency: 1 affected / 122 at risk

Adverse event: Self-extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 118 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Subject noted to have history of allergies. Ears became stuffy after wearing study headphones.
Frequency: 1 affected / 118 at risk

Adverse event: Impaired hearing
Serious: no
Organ System: Ear and labyrinth disorders
Notes: New loss of hearing acuity; determined to be of unknown etiology after ear, nose throat consult. No issues with understanding verbal communication with staff or research staff.
Frequency: 1 affected / 118 at risk

Adverse event: Self-extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Seizure activity
Serious: yes
Organ System: Nervous system disorders
Notes: seizure activity noted in patient after ICU admission for stroke
Frequency: 1 affected / 124 at risk

Adverse event: Impaired hearing
Serious: no
Organ System: Ear and labyrinth disorders
Notes: New loss of hearing acuity; determined to be of unknown etiology after ear, nose throat consult. No issues with understanding verbal communication with staff or research staff.
Frequency: 1 affected / 124 at risk
Study: NCT00440999

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Prolonged hospitalisation due to fever
Frequency: 1 affected / 228 at risk

Adverse event: Typhoid fever
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalisation
Frequency: 1 affected / 228 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 228 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 228 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 228 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 228 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 228 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 228 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 228 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 228 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 228 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 228 at risk
Study: NCT00441064

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 126 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 124 at risk
Study: NCT00441116

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 73 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 75 at risk
Study: NCT00441259

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk
Study: NCT00441363

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: The only SAE in the study was reported in a subject from the Cycloset™ treatment group who experienced unstable angina and dyspnea. Both events were deemed by the site investigator as unlikely related to study drug and resolved.
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

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

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk
Study: NCT00441441

Adverse event: Head Injury due to fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 173 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 173 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 173 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 173 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 173 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 173 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 173 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 173 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 177 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 177 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 177 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 177 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 177 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 177 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 177 at risk
Study: NCT00441480

Adverse event: Itching rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk
Study: NCT00441558

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1723 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1723 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1723 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1723 at risk

Adverse event: Malignant melonoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1723 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1723 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1723 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1723 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1723 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1723 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1723 at risk

Adverse event: Mitral valve prolapse
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1723 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1723 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1723 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 275 affected / 1723 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 131 affected / 1723 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 123 affected / 1723 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 124 affected / 1723 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 120 affected / 1723 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 113 affected / 1723 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 109 affected / 1723 at risk
Study: NCT00441883

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 43 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 28 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 28 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 28 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 28 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 45 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk
Study: NCT00441974

Adverse event: Hepatic mass
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1467 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1467 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1467 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1467 at risk

Adverse event: Muscle mass
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1467 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1467 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1467 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1467 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1467 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 86 affected / 1467 at risk
Study: NCT00442013

Adverse event: asthma excerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 149 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 149 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 93 affected / 147 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 77 affected / 147 at risk

Adverse event: Group A streptococcus
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 147 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 147 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 147 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 12 affected / 147 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 147 at risk

Adverse event: asthma excerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 147 at risk

Adverse event: Vomiting and strep throat
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 157 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 157 at risk

Adverse event: Pneumonia requiring hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Severe constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 150 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 150 at risk

Adverse event: Group A streptococcus
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 150 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 150 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 150 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 150 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 150 at risk