Study: NCT01008943

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Patient fractured the proximal end of fibula when fell horse-riding, which required medical intervention and resulted in persistent or significant disability or incapacity. It was adjudicated as not related to study procedures or AMDC treatment.
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: After AMDC treatment: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: After biopsy, before AMDC: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Blood urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Hemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Residual urine volume increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: White blood cell count increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: After AMDC treatment: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 16 at risk

Adverse event: After AMDC treatment: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: After biopsy, before AMDC: Urethral dilatation
Serious: no
Organ System: Renal and urinary disorders
Notes: Urethra dilated immediately proceding the injection procedure to allow passage of the needle into the urethra.
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 16 at risk

Adverse event: After AMDC treatment: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 16 at risk

Adverse event: After AMDC treatment: Menorrhagia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: After AMDC treatment: Ophthalmologic treatment
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 16 at risk