TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00901199

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Cholecystectomy
Frequency: 1 affected / 22 at risk

Adverse event: Central venous line infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Baseline liver iron 24.6 mg/g, cardiac MRI T2\* 4.8 ms, ejection fraction 67%. Two months into the study, presented to ER with abdominal pain, ascites, diarrhea, and leukocytosis. Expired during emergency colectomy from cardiac arrhythmias
Frequency: 1 affected / 22 at risk

Adverse event: Transfusion reaction
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk
Study: NCT00901225

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C
Frequency: 4 affected / 21 at risk
Study: NCT00901316

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: Burning eyes
Frequency: 1 affected / 495 at risk
Study: NCT00901394

Adverse event: PONV
Serious: no
Organ System: Nervous system disorders
Notes: Postopertaive nausea and vomiting
Frequency: 2 affected / 19 at risk

Adverse event: Postop. cardiac troponin elevation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk
Study: NCT00901576

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 37 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 37 at risk
Study: NCT00902018

Adverse event: increase in LFTs
Serious: no
Organ System: Hepatobiliary disorders
Notes: increase in ALT/AST
Frequency: 1 affected / 10 at risk
Study: NCT00902226

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Muscle spasticity
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 30 at risk
Study: NCT00902330

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: nonstudy related
Frequency: 1 affected / 77 at risk
Study: NCT00902564

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk
Study: NCT00902668

Adverse event: Rash: dermatitis associated with radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

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

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

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

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Taste alteration (dysgeusia)
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

Adverse event: Infection with unknown ANC - Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Fibrosis-cosmesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk
Study: NCT00903162

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Notes: Hot Flashes/Flushes
Frequency: 12 affected / 17 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Dryness of the vagina
Frequency: 11 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.
Frequency: 6 affected / 17 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle pain
Frequency: 12 affected / 17 at risk

Adverse event: Flu-like Symptoms, Fever, or Rigors
Serious: no
Organ System: General disorders
Notes: A disorder characterized by a group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body aches, malaise, loss of appetite and dry cough.
Frequency: 2 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a queasy sensation and/or the urge to vomit.
Frequency: 3 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: A disorder characterized by difficulty in falling asleep and/or remaining asleep.
Frequency: 3 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
Frequency: 6 affected / 17 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by a decrease in sexual desire or function.
Frequency: 4 affected / 17 at risk

Adverse event: Injection Site Reaction or Rash
Serious: no
Organ System: General disorders
Notes: A disorder characterized by an intense adverse reaction (usually immunologic) developing at the site of an injection.
Frequency: 3 affected / 17 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.
Frequency: 2 affected / 17 at risk
Study: NCT00903344

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT00903383

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 55 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 55 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 49 at risk
Study: NCT00903448

Adverse event: Skin Disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk
Study: NCT00903877

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk
Study: NCT00904033

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

Adverse event: Hypergycemia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Blood Urea Nitrogen Elevation - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

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

Adverse event: Hypergycemia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Hyperglycemia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Blood Urea Nitrogen Elevation - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Hypergycemia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Blood Urea Nitrogen Elevation - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypercalcemia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hyperkalemia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypergycemia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Blood Urea Nitrogen Elevation - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk
Study: NCT00904215

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Gastric polyps
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Varices oesophageal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1095 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1095 at risk
Study: NCT00904371

Adverse event: Carcinoma in situ
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 211 at risk

Adverse event: Lip oedema
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 211 at risk
Study: NCT00904488

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 5 at risk

Adverse event: critically low potassium (< 3.5 mmol/L) while receiving study therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: critically low magnesium (< 1.6 mg/dL) while receiving study therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 6 at risk

Adverse event: Hypotension resulting in holding antihypertensive doses
Serious: no
Organ System: Cardiac disorders
Notes: Reported as number of subjects affected/total at risk. Count of occurrence is total number of doses of antihypertensives being held.
Frequency: 1 affected / 6 at risk
Study: NCT00904722

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 30 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 30 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 30 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 30 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 30 at risk
Study: NCT00904748

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Laboratory change: urine
Serious: no
Organ System: General disorders
Frequency: 8 affected / 47 at risk

Adverse event: Laboratory change: red blood cell count
Serious: no
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Laboratory change: triglycerides
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Laboratory change: glucose
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Laboratory change: cholesterol
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Laboratory change: white blood cells
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Laboratory changes unspecified
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk
Study: NCT00904826

Adverse event: Meningococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 14 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 14 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 14 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 14 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Swelling or ankle swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Nasal congestion or watery eyes
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk
Study: NCT00904969

Adverse event: Urinary Incontinence - Persistant
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Intra-operative Bleeding of Aberrant Vessel
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain/ Discomfort
Serious: no
Organ System: General disorders
Frequency: 8 affected / 50 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 50 at risk

Adverse event: Urinary Incontinence - Persistent
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 50 at risk

Adverse event: Post micturition dribble
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pain/ Discomfort With Erections
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: Urinary Incontinence - De Novo Stress
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Scrotal Pain/ Swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Decreased Penile Sensitivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Penile oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Light Post-Op Bleed
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Penile Pain with Orgasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: Worsening Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk