Study: NCT00721214

Adverse event: Blood/Bone Marrow - Other (Specify, death-died of progressive MDS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Death- died of progressive MDS
Frequency: 4 affected / 16 at risk

Adverse event: Blood/Bone Marrow- Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: progression/relapse of MDS/AML
Frequency: 4 affected / 16 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Primary Attribution: Unlikely Detailed Attribution: Other Pt with long history of seizure disorder had single seizure. Was seen in ED and discharged to home
Frequency: 1 affected / 16 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Primary Attribution: Unrelated Detailed Attribution: Other Drug: 5-Azacytidine Admitted for abdominal pain, found to have acute cholecystitis and had lap cholycystectomy.
Frequency: 1 affected / 16 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Primary Attribution: Unrelated Detailed Attribution: Other Drug: 5-Azacytidine antibiotics, supportive care Grade 2
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Primary Attribution: Unrelated Detailed Attribution: Other Drug: 5-Azacytidine
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: yes
Organ System: Investigations
Notes: Fatigue (asthenia, lethargy, malaise) Primary Attribution: Unrelated Detailed Attribution: Other Drug: 5-Azacytidine
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea (shortness of breath) Primary Attribution: Possible Detailed Attribution: Investigational Therapy Drug: 5-Azacytidine
Frequency: 1 affected / 16 at risk

Adverse event: Infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L) - Skin (cellulitis) Primary Attribution:Possible Detailed Attribution:Other Drug: 5-Azacytidine
Frequency: 1 affected / 16 at risk

Adverse event: Infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Infection with unknown ANC
Frequency: 2 affected / 16 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hemorrhage/Bleeding
Frequency: 1 affected / 16 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: patient admitted 3/12/12 for fever and mental status changes, confusion worsened and patient found to have basal ganglia hemorrhage secondary to toxoplasmosis, died in paliative care unit 4/17/12
Frequency: 1 affected / 16 at risk

Adverse event: Died of Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 16 at risk

Adverse event: Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Perforation, GI - Colon
Frequency: 1 affected / 16 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 16 at risk

Adverse event: Myositis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Myositis (inflammation/damage of muscle)
Frequency: 1 affected / 16 at risk