TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01594424

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Fluid overload and pulmonary congestion as a result of underdialysis
Frequency: 1 affected / 10 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Renal and urinary disorders
Notes: Hyperkalemia in the same patient who had pneumonia
Frequency: 1 affected / 10 at risk

Adverse event: Infective colitis with colonic perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 transplanted patient developed infective colitis with colonic perforation required bowel resection (possibly related to study drug)
Frequency: 1 affected / 10 at risk

Adverse event: Bells Palsy
Serious: yes
Organ System: Infections and infestations
Notes: 1 transplanted patient
Frequency: 1 affected / 10 at risk

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

Adverse event: Abdominal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: During hemodialysis pre-transplant, with normal amylase and lipse
Frequency: 1 affected / 10 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: elevated liver function enzymes
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 10 at risk

Adverse event: Elevated blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Minimal infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT01594476

Adverse event: IUD expulsion
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Partial or complete expulsion
Frequency: 2 affected / 100 at risk
Study: NCT01594762

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 97 at risk

Adverse event: Diabetic ketoacidiosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 97 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Foot operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 97 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 97 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 97 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk
Study: NCT01594970

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 295 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 295 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 248 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 257 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 257 at risk
Study: NCT01595386

Adverse event: Lung assist device therapy
Serious: yes
Organ System: Cardiac disorders
Notes: Subject's requiring extracorporeal membrane oxygenation support post-cardiopulmonary bypass
Frequency: 2 affected / 21 at risk

Adverse event: Death
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 21 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 21 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Subjects whose blood glucose level was \>180 mg/dL
Frequency: 15 affected / 21 at risk

Adverse event: Antibiotics for suspected infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 21 at risk

Adverse event: Lung assist device therapy
Serious: yes
Organ System: Cardiac disorders
Notes: Subject's requiring extracorporeal membrane oxygenation support post-cardiopulmonary bypass
Frequency: 1 affected / 19 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 19 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Subjects whose blood glucose level was \>180 mg/dL
Frequency: 10 affected / 19 at risk

Adverse event: Antibiotics for suspected infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 19 at risk
Study: NCT01595646

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: PT experienced chest pain during MRI.
Frequency: 1 affected / 12 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: PT began to feel some anxiety during the MRI scan.
Frequency: 1 affected / 12 at risk

Adverse event: Congestion
Serious: no
Organ System: General disorders
Notes: PT reported head congestion.
Frequency: 1 affected / 12 at risk

Adverse event: Cold & Flu Symptoms
Serious: no
Organ System: General disorders
Notes: PT reported having symptoms resembling a cold or flu.
Frequency: 1 affected / 12 at risk
Study: NCT01595854

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT01596127

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Muscle spasticity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT01596699

Adverse event: Veno-occlusive disease (VOD)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 10 at risk

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

Adverse event: Veno-occlusive disease (VOD)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 6 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 6 at risk

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

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

Adverse event: Lymph gland infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk
Study: NCT01596842

Adverse event: vaginal spotting
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk
Study: NCT01597128

Adverse event: Abdominal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Abdominal Wound Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 18 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 18 at risk

Adverse event: Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 18 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Hernia Recurrence
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 18 at risk

Adverse event: Parastomal Hernia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal Wound/Mesh Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: Abdominal Wound Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 17 at risk

Adverse event: Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Renal decompensation requiring dialysis
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal compartment syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Chronic Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hernia Recurrence
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 17 at risk
Study: NCT01597141

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk
Study: NCT01597440

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Mildly lethargic
Frequency: 1 affected / 1 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: tachypnea, hyperpnea
Frequency: 1 affected / 1 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: vomited early in the AM
Frequency: 1 affected / 1 at risk

Adverse event: Ketosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: large ketones in urine
Frequency: 1 affected / 1 at risk

Adverse event: Acidosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: serum bicarbonate abnormal
Frequency: 1 affected / 1 at risk

Adverse event: low white blood counts
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low overall white blood counts and low absolute neutrophil count
Frequency: 1 affected / 1 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: low hemoglobin and hematocrit
Frequency: 1 affected / 1 at risk
Study: NCT01597778

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiorespiratory
Frequency: 1 affected / 186 at risk

Adverse event: Arterial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Arterial injury
Frequency: 1 affected / 186 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Infusion related reaction
Frequency: 1 affected / 186 at risk

Adverse event: Psychiatric disorders Delirium
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychiatric disorders Delirium
Frequency: 1 affected / 186 at risk

Adverse event: Myelodysplastic syndrome
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MYELODYSPLASTIC SYNDROME
Frequency: 1 affected / 186 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Supraventricular tachycardia
Frequency: 1 affected / 182 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Vascular access complication
Frequency: 1 affected / 182 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Acute myeloid leukemia
Frequency: 1 affected / 182 at risk

Adverse event: Central nervous system lesion
Serious: yes
Organ System: Nervous system disorders
Notes: Central nervous system lesion
Frequency: 1 affected / 182 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope
Frequency: 1 affected / 182 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory failure
Frequency: 2 affected / 182 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Embolism
Frequency: 1 affected / 182 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Hypotension
Frequency: 1 affected / 182 at risk
Study: NCT01597791

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary retention
Frequency: 6 affected / 20 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary retention
Frequency: 6 affected / 18 at risk
Study: NCT01598025

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Myelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk
Study: NCT01598129

Adverse event: Duodenal obstruction and small intestinal hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Muscle rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypoalbuminemia and peripheral oedema
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 12 affected / 12 at risk
Study: NCT01598207

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT01598610

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 220 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 220 at risk
Study: NCT01598701

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk
Study: NCT01598740

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

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

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

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

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

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypotenstion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk
Study: NCT01598896

Adverse event: Nausea associated with Placebo
Serious: no
Organ System: General disorders
Notes: 1 subject called study staff to say the medication was making her nauseous. When subject was called back, the nausea was gone and did not occur again. The PI called the subject who stated it must have been unrelated to study
Frequency: 1 affected / 4 at risk