TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00193050

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 110 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 1 affected / 110 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 110 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Notes: Fatal Legionnaire's disease
Frequency: 1 affected / 110 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Infection - Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 110 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutropenia
Frequency: 45 affected / 110 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia
Frequency: 19 affected / 110 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 13 affected / 110 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 110 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 110 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 110 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 110 at risk
Study: NCT00193206

Adverse event: Cardiac Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Angina
Frequency: 1 affected / 123 at risk

Adverse event: Infection - Skin
Serious: yes
Organ System: Infections and infestations
Notes: Cellulitis
Frequency: 3 affected / 123 at risk

Adverse event: Pain - Chest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 123 at risk

Adverse event: Infection - Gastrointestinal
Serious: yes
Organ System: Infections and infestations
Notes: Colitis
Frequency: 1 affected / 123 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 123 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 123 at risk

Adverse event: Infection - Vein
Serious: yes
Organ System: Infections and infestations
Notes: Septic Thrombophlebitis
Frequency: 2 affected / 123 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Intercurrent Illness
Frequency: 1 affected / 123 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 123 at risk

Adverse event: Pain - Liver
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 123 at risk

Adverse event: Infection - Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Infection - Skin
Serious: yes
Organ System: Infections and infestations
Notes: Port Site Infection
Frequency: 3 affected / 123 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Progressive Disease
Frequency: 1 affected / 123 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Psychiatric disorders
Notes: Suicidal Ideations
Frequency: 1 affected / 123 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutropenia
Frequency: 13 affected / 123 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia
Frequency: 7 affected / 123 at risk

Adverse event: Arthralgia/Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 123 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 123 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 123 at risk
Study: NCT00194116

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk
Study: NCT00194129

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 15 at risk

Adverse event: Polyuria/Polydipsia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 15 at risk

Adverse event: Cognitive Dysfunction
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 15 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 15 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 16 at risk

Adverse event: Polyuria/Polydipsia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 16 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

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

Adverse event: Sexual dysfunction
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 16 at risk

Adverse event: Cognitive Dysfunction
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 16 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk
Study: NCT00194532

Adverse event: gastrointestinal(GI) side effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea, vomiting, loose stools, abdominal discomfort, other GI
Frequency: 23 affected / 137 at risk

Adverse event: central nervous system (CNS) side effect
Serious: no
Organ System: Nervous system disorders
Notes: headache, dizziness
Frequency: 17 affected / 137 at risk

Adverse event: vaginal side effects
Serious: no
Organ System: Reproductive system and breast disorders
Notes: vaginal discomfort, discharge, itching, or self-diagnosed yeast
Frequency: 8 affected / 137 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: included under GI side effects
Frequency: 13 affected / 137 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: included under GI side effects
Frequency: 7 affected / 137 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: included under GI side effects
Frequency: 7 affected / 137 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: included under CNS side effects
Frequency: 4 affected / 137 at risk

Adverse event: gastrointestinal(GI) side effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea, vomiting, loose stools, abdominal discomfort, other GI
Frequency: 21 affected / 137 at risk

Adverse event: central nervous system (CNS) side effect
Serious: no
Organ System: Nervous system disorders
Notes: headache, dizziness
Frequency: 15 affected / 137 at risk

Adverse event: vaginal side effects
Serious: no
Organ System: Reproductive system and breast disorders
Notes: vaginal discomfort, discharge, itching, or self-diagnosed yeast
Frequency: 7 affected / 137 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: included under GI side effects
Frequency: 8 affected / 137 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: included under GI side effects
Frequency: 9 affected / 137 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: included under GI side effects
Frequency: 7 affected / 137 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: included under CNS side effects
Frequency: 7 affected / 137 at risk
Study: NCT00194675

Adverse event: death from myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Subject had history of cardiovascular disease prior to randomization and normal hematocrit. Subject died during month 6.
Frequency: 1 affected / 27 at risk

Adverse event: non-ST segment myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Subject had history of cardiovascular disease prior to randomization and normal hematocrit. Adverse event occurred during month 4.
Frequency: 1 affected / 27 at risk

Adverse event: mild breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 27 at risk

Adverse event: increase in prostate specific antigen (PSA)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 27 at risk

Adverse event: Elevated hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: transient rash at gel application site
Frequency: 1 affected / 27 at risk

Adverse event: mild breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 26 at risk

Adverse event: ezcema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: exacerbation of pre-existing colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk
Study: NCT00194896

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Hypertension and diabetes related. Unknown if related to study.
Frequency: 1 affected / 15 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Endocrine disorders
Notes: Unknown if study related.
Frequency: 1 affected / 15 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Unknown if related to study.
Frequency: 1 affected / 15 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: Unknown if related to study.
Frequency: 2 affected / 21 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Unknown if related to study.
Frequency: 1 affected / 21 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk
Study: NCT00195429

Adverse event: Infection Disease
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 24 at risk

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

Adverse event: Diabetes Mellitus post-transplant
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 24 at risk

Adverse event: Infection Disease
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 23 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Diabetes Mellitus post-transplant
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk
Study: NCT00196313

Adverse event: Excruciating pain rlated to menstruation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 47 at risk

Adverse event: Exacerbation of Stress
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 47 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 47 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 47 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 47 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 48 at risk

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 48 at risk
Study: NCT00197106

Adverse event: Worsening of asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 78 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Hyperventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Arthritis reactive
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Bone cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 80 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 80 at risk
Study: NCT00197184

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 6 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk
Study: NCT00198029

Adverse event: Unlikely Related Pseudogout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: One patient had an acute attack of crystal proven pseudogout in the ipsilateral wrist 33 days after the last CMC hyaluronic acid injection. The patient had no previous history of inflammatory arthritis and had been well in the interim.
Frequency: 1 affected / 32 at risk

Adverse event: Unlikely Related GI Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A 74 year old patient withdrew after a gastrointestinal bleed that occurred 69 days after the last HA injection.
Frequency: 1 affected / 32 at risk

Adverse event: Possibly but Unlikely Related Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: One patient slipped on the way to the hospital for the third HA injection and suffered a broken scapula; this patient completed the study.
Frequency: 1 affected / 32 at risk

Adverse event: Pain at Injection Site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Out of the 96 total injections, 3 resulted in post-injection pain and swelling requiring treatment. Two were after the second injection, and one was after the third injection. All symptoms rapidly resolved with ice, NSAIDS or COX-2 inhibitor.
Frequency: 3 affected / 32 at risk
Study: NCT00198081

Adverse event: NERVOUS SYSTEM DISORDERS - OTHER, [NEUROLEPTIC REACTION]
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: CARDIAC DISORDERS - OTHER, [CONGESTIVE HEART FAILURE]
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: EKG CHANGES
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: ARRTHYTHMIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pancreatic fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: EDEMA: LIMB SWELLING OF THE ARMS AND/OR LEGS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: FLU-TYPE SYMPTOMS (INCLUDING BODY ACHES, FEVER, CHILLS, TIREDNESS,LOSS OF APPETITE, COUGH)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, [RUNNY NOSE]
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk