TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01537419

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 63 at risk

Adverse event: Non-suicidal self-injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 63 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 63 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: High level of suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 63 at risk

Adverse event: Abuse/Neglect
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 63 at risk

Adverse event: Other
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 63 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 66 at risk

Adverse event: Non-suicidal self-injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 66 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 66 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 66 at risk

Adverse event: High level of suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 66 at risk

Adverse event: Abuse/Neglect
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 66 at risk

Adverse event: Imprisonment
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 66 at risk

Adverse event: Other
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 66 at risk
Study: NCT01537549

Adverse event: Leg Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Gastro Disturbances
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Odor of Urine, Breath, or Sweat
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Skin Rashes, Itching, Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Bronchoconstriction, Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Other Possible Effects
Serious: no
Organ System: General disorders
Notes: Restlessness, insomnia, dizziness, seizures
Frequency: 6 affected / 11 at risk
Study: NCT01537900

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT01537926

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Event was not related to administration of NAC.
Frequency: 2 affected / 29 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 29 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Event is not related to NAC.
Frequency: 2 affected / 29 at risk
Study: NCT01538199

Adverse event: gastro-intestinal sickness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

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

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

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

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

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

Adverse event: self-harm
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: visual illusions (vivid colors)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: decreased memory; word finding difficulties
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: left torso pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eructation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: gastro-intestinal sickness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: pressure/pain on back of head during 4T Scan
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: dizziness/tingling sensation in head
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk
Study: NCT01538472

Adverse event: Death not related to Common Toxocity Adverse Events (CTCAE)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pulmonary Infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Secondary Graft Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Death due to Septic Shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Stem cell Infusion Reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Alanine Aminotransferase (ALT) Increase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 40 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Increased Bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 40 at risk

Adverse event: Alkaline Phosphatase Elevated
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk
Study: NCT01538719

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

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Allergic Reaction on Abdomen
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

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

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

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

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01538966

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 15 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk
Study: NCT01539239

Adverse event: Corneal Edema Mild to Mod after 1 month
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 369 at risk

Adverse event: Repair of malpositioned IOL haptic
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 369 at risk

Adverse event: Orbital hemangioma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 369 at risk

Adverse event: Squamous cell carcinoma of the conjunctiva
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 369 at risk

Adverse event: Retinal Complications
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 369 at risk

Adverse event: Anterior uveitis/iritis (non-persistent)
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 369 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 369 at risk

Adverse event: Device obstruction, partial or complete
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 369 at risk

Adverse event: Peripheral anterior synechiae without device obstruction
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 369 at risk

Adverse event: Worsening of visual field MD by greater than or equal to 2.5 dB compared with preoperative
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 369 at risk

Adverse event: BCVA loss greater than or equal to 2 lines ETDRS greater than or equal to 3 months
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 187 at risk

Adverse event: Glaucoma progression
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 187 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 187 at risk

Adverse event: Worsening of visual field MD by greater than or equal to 2.5 dB compared with preoperative
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 187 at risk

Adverse event: Retinal Complications
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 187 at risk

Adverse event: Anterior uveitis/iritis (non-persistent)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 187 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 187 at risk

Adverse event: Worsening of visual field MD by greater than or equal to 2.5 dB compared with preoperative
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 187 at risk
Study: NCT01539590

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3 at risk

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

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk
Study: NCT01539642

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Investigator deemed event was unrelated to study drug
Frequency: 1 affected / 114 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 114 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 114 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 114 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 114 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 114 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 114 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: All adverse events in this table were assessed by the PI as possibly or probably related to study drug
Frequency: 2 affected / 114 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 114 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 58 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk
Study: NCT01539759

Adverse event: Uterine perforation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Uterine Perforation with IUD placement
Frequency: 1 affected / 56 at risk
Study: NCT01539837

Adverse event: Decline in white cell counts
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Muscular joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 7 at risk

Adverse event: Decline in white cell counts
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Muscular joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 7 at risk
Study: NCT01539863

Adverse event: Minor
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local soreness Felt tired
Frequency: 43 affected / 164 at risk

Adverse event: Minor
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Local soreness Felt tired
Frequency: 40 affected / 160 at risk
Study: NCT01539980

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patients may experience itching around the operation wounds
Frequency: 2 affected / 30 at risk
Study: NCT01540162

Adverse event: Acute Respiratory and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalisation due to ARIs and GIs
Frequency: 11 affected / 30 at risk

Adverse event: Acute Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: acute rhinitis, acute rhinopharyngitis, acute bronchitis
Frequency: 15 affected / 30 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: infant colic, acute enterocolitis, constipation, regurgitation, diarrhoea
Frequency: 12 affected / 30 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: diaper dermatitis, atopic dermatitis
Frequency: 3 affected / 30 at risk

Adverse event: Changed Blood Parameter
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Acute Respiratory and Gastrointestinal Infections
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalisation due to ARIs and GIs
Frequency: 20 affected / 32 at risk

Adverse event: Acute Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: acute rhinitis, acute rhinopharyngitis, acute bronchitis
Frequency: 22 affected / 32 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: infant colic, acute enterocolitis, constipation, regurgitation, diarrhoea
Frequency: 13 affected / 32 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: diaper dermatitis, atopic dermatitis
Frequency: 3 affected / 32 at risk

Adverse event: Changed Blood Parameter
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 32 at risk
Study: NCT01540487

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk
Study: NCT01540773

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk
Study: NCT01540851

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk
Study: NCT01540994

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One patient hospitalized for rectal bleeding after completion of XRT, but colonoscopy showed diverticulitis without evidence of radiation changes.
Frequency: 1 affected / 12 at risk

Adverse event: Acute Genitourinary Toxicity (Grade 4)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Bladder outlet obstruction requiring temporary foley catheter placement.
Frequency: 1 affected / 12 at risk

Adverse event: Late Genitourinary Toxicity (Grade 1)
Serious: no
Organ System: Renal and urinary disorders
Notes: Frequency of urination or nocturia twice pretreatment habit/dysuria, urgency not requiring medication
Frequency: 4 affected / 12 at risk

Adverse event: Late Gastrointestinal Toxicity (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate diarrhea and colic; bowel movement \> 5 times daily; excessive rectal mucus or intermittent bleeding
Frequency: 2 affected / 12 at risk
Study: NCT01541254

Adverse event: Stroke/TIA
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 31 at risk

Adverse event: Hematoma at access site
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Stroke or TIA
Serious: no
Organ System: General disorders
Notes: non-serious
Frequency: 2 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk