Study: NCT00115349

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Nausea \& abdominal discomfort occurring while taking deferiprone/placebo. Also reported "muscular type" aches \& pains in the upper chest and arms. Severe elevation in liver enzymes was identified.
Frequency: 1 affected / 11 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Subject complaint of congestion and bloating. ECHO EF%= 20%, a decrease from 45%. Admitted for higher dose deferoxamine, \& management. Deferoxamine was increased to 75 mg/kg/day, 7 days per week over 24 hours. Lasix 40 mg IV x 1 was administered.
Frequency: 1 affected / 11 at risk

Adverse event: Clot
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Pt had arm swelling and ultrasound revealed clot in left PICC line. Pt treated with vancomycin.
Frequency: 1 affected / 11 at risk

Adverse event: Meningitis (unkown viral vs. bacterial)
Serious: yes
Organ System: Infections and infestations
Notes: Subject developed a fever 39.2C PO. Creatinine elevated to 2.2. Study drug held. CT without contrast done, "no obvious signs of meningitis or abcess." Treated w/ doses of Vancomycin and Cefotaxime.
Frequency: 1 affected / 11 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Notes: A routine chemistry showed elevated BUN 30mg/dl and creatinine 1.5mg/dl.
Frequency: 1 affected / 11 at risk

Adverse event: high grade fever and chills
Serious: yes
Organ System: Infections and infestations
Notes: Subject complained of high grade fever and chills associated with dysuria. Subject presented to the ER and prelim results showed urinary tract infection but was admitted for monitoring due to low blood pressure.
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Subject c/o stomach discomfort. 05/21 ANC was 1.4 and L1/Placebo was stopped. CBC was done and the ANC was 1.9. Treatment was restarted. An MRI (R2/T2\*) was performed to assess liver iron. Summary stopped L1/Placebo, stopped DFO-S, MRI performed.
Frequency: 1 affected / 11 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Subject admitted with CHF. Noted tachycardia to 140s. He was in atrial flutter, then atrial fibrillation. Was not hypotensive w/ no evidence of ventricular arrhythmia. Rx and converted to NSR. This event was possibly related to study drug.
Frequency: 2 affected / 11 at risk

Adverse event: Syncope
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Admitted with episode of syncope. His vision became dark and he felt dizzy. He was unable to support himself and fell to the ground hitting the side of his face. He reports that he was conscious throughout.
Frequency: 1 affected / 11 at risk

Adverse event: Watery diarrhea & hypotension
Serious: yes
Organ System: General disorders
Notes: 5 day history of watery diarrhea. Dx w/ dehydration and syncopal event.
Frequency: 1 affected / 11 at risk

Adverse event: Retinal toxicity- drug induced
Serious: yes
Organ System: Eye disorders
Notes: Distance vision was blurry and was seen by ophthalmology. ERG analysis shows deficits in both scotopic and photopic responses. These were not present on previous ERG. He c/o blurry vision and could not be corrected with glasses.
Frequency: 1 affected / 11 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum potassium =7.5 meq/L and received calcium carbonate infusion, and normal saline bolus. Glucose rose to 635 mg/dL. History of insulin dependent diabetes. Received Lasix \& NS bolus were given. Potassium level returned to normal.
Frequency: 1 affected / 11 at risk

Adverse event: Central venous line infection
Serious: yes
Organ System: Infections and infestations
Notes: Subject was admitted with cellulitis at the insertion site of his central venous catheter. The subject received vancomycin I.V. \& developed Redman's syndrome. The vancomycin was stopped and was given Nafcillin IV.
Frequency: 1 affected / 11 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

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

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 11 at risk

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

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fanconi
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 11 at risk

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

Adverse event: Kicked in chest
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 11 at risk

Adverse event: Low Grade Fever and Sore Throay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

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

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

Adverse event: Otitis media
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Palpitations with dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Phlebotic pain at blood infusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

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

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

Adverse event: Strep Throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Vertigo
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 11 at risk

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

Adverse event: Allergic transfusion reactions hives
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

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

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

Adverse event: Toothache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Subject complaint of congestion and bloating. ECHO EF%= 20%, a decrease from 45%. Admitted for higher dose deferoxamine, \& management. Deferoxamine was increased to 75 mg/kg/day, 7 days per week over 24 hours. Lasix 40 mg IV x 1 was administered.
Frequency: 2 affected / 9 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Notes: Subject complained of palpitations. ECG showed Atrial fibrillation. converting to normal sinus rhythm before started on any medication.
Frequency: 1 affected / 9 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Subject had been feeling fatigued with episodes of CP. Rx w/ Lasix and aldactone. Subject feeling worse with nausea and vomiting.CT scan showed left lower lobe pneumonia. Started on 10 day course of Levaquin. Discharged in good condition.
Frequency: 1 affected / 9 at risk

Adverse event: Splenectomy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subject scheduled her for splenectomy. Had no complications.
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Allergic transfusion reactions hives
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 9 at risk

Adverse event: Heart palpatations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Shortness of Breath/fatigue
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Ankle pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk