TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02683421

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Pain at injection site for 5 days following injection
Frequency: 1 affected / 4 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: probably related to tilmanocept injection
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: probably related to tilmanocept injection
Frequency: 1 affected / 5 at risk
Study: NCT02683525

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 37 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 37 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 37 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 37 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 37 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 37 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 37 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 37 at risk
Study: NCT02683577

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

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

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

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

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

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

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

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk
Study: NCT02683707

Adverse event: Pain >5/10
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 105 at risk

Adverse event: Pain >5/10
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 107 at risk
Study: NCT02683772

Adverse event: Asthma exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient woke up with an asthma exacerbation at 4:37am. Patient utilized her normal home routine treatment. This event was determined to be 'not related' to the device or study treatment.
Frequency: 1 affected / 42 at risk
Study: NCT02683785

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk
Study: NCT02684097

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: Upper Respiratory Infection (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Upper Respiratory Infection (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertensive urgency
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk
Study: NCT02684123

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diffuse arthralgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

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

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

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

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk
Study: NCT02684136

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache, dizziness, residual sedation - adverse event terms can not be separated
Frequency: 8 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache, dizziness, residual sedation - adverse event terms can not be separated
Frequency: 3 affected / 10 at risk
Study: NCT02684396

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

Adverse event: Blood pressure orthostatic abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

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

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

Adverse event: Blood pressure orthostatic decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk
Study: NCT02684435

Adverse event: Bilateral back pain that resolved by the time of discharge.
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Bilateral back pain that resolved by the time of discharge. Patient also has chronic back issues and some difficulty with mobility.
Frequency: 1 affected / 63 at risk
Study: NCT02684591

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: Acid Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk
Study: NCT02684630

Adverse event: Citrate toxicity
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Metabolism and nutrition disorders including overall and citrate toxicity.
Frequency: 2 affected / 65 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Nervous system disorders including paraesthesia.
Frequency: 2 affected / 65 at risk

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions including injection site extravasation.
Frequency: 1 affected / 65 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Nervous system disorders including paraesthesia.
Frequency: 1 affected / 63 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: Nervous system disorders including presyncope.
Frequency: 1 affected / 63 at risk
Study: NCT02684851

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk
Study: NCT02685007

Adverse event: Abdominal incarcerated hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 131 at risk
Study: NCT02685033

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Inflammation of wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk
Study: NCT02685072

Adverse event: nausea, vomiting, diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: wrist and back injury due to fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: ER visit for unknown reason
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: ER visit for unknown reason
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: 3 Menses in one month
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 31 at risk
Study: NCT02685293

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk
Study: NCT02685358

Adverse event: Acute anger
Serious: no
Organ System: Psychiatric disorders
Notes: Participant became angry during the Clinician Administered PTSD Interview. The interviewer ended the assessment early. The participant was thanked for his time completing the portions of the assessment he did participate in.
Frequency: 1 affected / 115 at risk

Adverse event: Emergency Department Visit
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The participant presented to community ER and was discharged the next day with right leg deep vein thrombosis (DVT, blood clot). Scheduled to follow up with the Syracuse VA.
Frequency: 1 affected / 119 at risk
Study: NCT02686138

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 293 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 293 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 300 at risk

Adverse event: Ovarian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 300 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 300 at risk
Study: NCT02686814

Adverse event: Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pneumothorax and Pleural Effusions Nec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anemias
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Notes: Procedure-Related
Frequency: 3 affected / 11 at risk

Adverse event: Ventricular Arrhythmias and Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Coagulation and Bleeding Analyses
Serious: no
Organ System: Investigations
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Digestive Enzymes
Serious: no
Organ System: Investigations
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Hepatobiliary Function Diagnostic Procedures
Serious: no
Organ System: Investigations
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Protein Metabolism Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Disturbances in Initiating and Maintaining Sleep
Serious: no
Organ System: Psychiatric disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Conditions Associated with Abnormal Gas Exchange
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Pneumothorax and Pleural Effusions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Vascular Hypertensive Disorders
Serious: no
Organ System: Vascular disorders
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Infections and infestations
Notes: Procedure-Related
Frequency: 1 affected / 11 at risk

Adverse event: Supraventricular Arrhythmias
Serious: no
Organ System: Cardiac disorders
Notes: Device - Related
Frequency: 1 affected / 11 at risk
Study: NCT02687126

Adverse event: Arterial puncture
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 106 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Local site hematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 106 at risk
Study: NCT02687139

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk
Study: NCT02687815

Adverse event: Hospitalization for asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 96 at risk

Adverse event: Eosinophilia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 96 at risk

Adverse event: severe neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pneumonia/otitis/hives
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Fractures
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fractures
Frequency: 5 affected / 96 at risk

Adverse event: Hospitalization for asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 96 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 96 at risk

Adverse event: Fractures
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fractures
Frequency: 4 affected / 96 at risk