Study: NCT00617942

Adverse event: gr 3port infection,
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Influenza
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: gr 4 sepsis, intubated
Serious: yes
Organ System: Investigations
Notes: neutro 3, anemia 3, thromb 4, HTN 4, arf 3, hypok 4, hypocal 4, ards 4, hyperbili 3, tach 4, fever 2
Frequency: 1 affected / 37 at risk

Adverse event: Diarrhea gr 2, Nausea gr 3, infection gr 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: infection normal ANC/viral grade 1
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: gr 3cellulitis - breast
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: gr 3 diarrhea, gr 2 neutropenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: UTI, gr 3 ANC, gr 3 HGB, Gr3 infection, Gr 2 fever and pain, gr1 rigor
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 32 affected / 37 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 32 affected / 37 at risk

Adverse event: plt
Serious: no
Organ System: Investigations
Frequency: 33 affected / 37 at risk

Adverse event: HGB
Serious: no
Organ System: Investigations
Frequency: 35 affected / 37 at risk

Adverse event: M/A
Serious: no
Organ System: Investigations
Frequency: 10 affected / 37 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 7 affected / 37 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 5 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 28 affected / 37 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 3 affected / 37 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 21 affected / 37 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 6 affected / 37 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Investigations
Frequency: 6 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 8 affected / 37 at risk

Adverse event: AST/ALT
Serious: no
Organ System: Investigations
Frequency: 28 affected / 37 at risk

Adverse event: Neurosensory
Serious: no
Organ System: Investigations
Frequency: 11 affected / 37 at risk

Adverse event: Neuromuscular
Serious: no
Organ System: Investigations
Frequency: 9 affected / 37 at risk

Adverse event: N/A
Serious: no
Organ System: Investigations
Frequency: 6 affected / 37 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Investigations
Frequency: 12 affected / 37 at risk

Adverse event: Mg
Serious: no
Organ System: Investigations
Frequency: 20 affected / 37 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 7 affected / 37 at risk

Adverse event: Phos
Serious: no
Organ System: Investigations
Frequency: 4 affected / 37 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Frequency: 6 affected / 37 at risk

Adverse event: HTN
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Abd pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: tinnuitius
Serious: no
Organ System: Investigations
Frequency: 2 affected / 37 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 2 affected / 37 at risk

Adverse event: Chest pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: fever unknown etiology gr 1, lymphatics gr 1
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Syncopal epidose gr 3, dehydration gr 2, diabetes gr 2, anemia gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: thrombus occlusive L IJ gr 3, hypomagnesia gr 1, hypokalemia gr 1
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: dehydr gr3, chest pain gr 3,
Serious: yes
Organ System: Investigations
Notes: Hypotension gr 2, HGB gr 3, Fever gr2, creatinine gr 1, diarrhea gr 2, infection gr 3, ANC gr 3,
Frequency: 1 affected / 23 at risk

Adverse event: gr 3 left jugular thrombis , anemia gr 2,
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: left ear otitis externa gr 3, ANC 4, WBC 2 Diarrhea 1
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: vomit gr 3, Nausea gr 3, diarrhea gr2, GI bleed gr 2, Abdominal pain rg3,
Serious: yes
Organ System: Investigations
Notes: hgb gr 2, Na 1, K 1, Ca 1, ANC 2, Anorexia 3,dehydration gr3, cr gr 1, WBC gr 2,
Frequency: 1 affected / 23 at risk

Adverse event: vomiting gr 3, infection Cdiff gr 3, Hypokalemia gr 1, gr 1 hypomagnesia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: right upper extremity cellulitis gr 3,
Serious: yes
Organ System: Investigations
Notes: right ue pain gr 2, UTI gr 2, WBC gr 2, HGB gr 2, ANC gr 2, K gr 2, hypoalbum gr 1, INR gr 1, constipation gr 1,
Frequency: 1 affected / 23 at risk

Adverse event: gr 3 ulcerative colitis exacerbation with and without gr 1 fever)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 21 affected / 23 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 19 affected / 23 at risk

Adverse event: plt
Serious: no
Organ System: Investigations
Frequency: 20 affected / 23 at risk

Adverse event: HGB
Serious: no
Organ System: Investigations
Frequency: 22 affected / 23 at risk

Adverse event: M/A
Serious: no
Organ System: Investigations
Frequency: 9 affected / 23 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 23 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 11 affected / 23 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 21 affected / 23 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 15 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 18 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 6 affected / 23 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Investigations
Frequency: 9 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 17 affected / 23 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Investigations
Frequency: 13 affected / 23 at risk

Adverse event: AST/ALT
Serious: no
Organ System: Investigations
Frequency: 9 affected / 23 at risk

Adverse event: Neurosensory
Serious: no
Organ System: Investigations
Frequency: 20 affected / 23 at risk

Adverse event: Neuromuscular
Serious: no
Organ System: Investigations
Frequency: 7 affected / 23 at risk

Adverse event: N/A
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Investigations
Frequency: 8 affected / 23 at risk

Adverse event: Mg
Serious: no
Organ System: Investigations
Frequency: 7 affected / 23 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 7 affected / 23 at risk

Adverse event: Phos
Serious: no
Organ System: Investigations
Frequency: 4 affected / 23 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Frequency: 6 affected / 23 at risk

Adverse event: HTN
Serious: no
Organ System: Investigations
Frequency: 3 affected / 23 at risk

Adverse event: tinnuitius
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Investigations
Frequency: 5 affected / 23 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: ocular
Serious: no
Organ System: Investigations
Frequency: 4 affected / 23 at risk

Adverse event: rectal bleed
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Insomnia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: Alopecia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Chills
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Oedema
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Troponin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: hyperpigmentation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: gr 3cellulitis - breast
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: gran mal seizure-2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: allergic rxn
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Febrile neutropenia gr 2, Anemia 2, ANC 4,
Serious: yes
Organ System: Investigations
Notes: External ear inflammation 1, tachycardia 1, PLT 1, Myalgias 2
Frequency: 1 affected / 29 at risk

Adverse event: suicidal ideation gr 2 and depression gr 3 not related
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: post re-construction pt experienced seroma grade 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: hernia grade 3 secondary to surgery healing issue
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 12 affected / 29 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 7 affected / 29 at risk

Adverse event: plt
Serious: no
Organ System: Investigations
Frequency: 6 affected / 29 at risk

Adverse event: HGB
Serious: no
Organ System: Investigations
Frequency: 23 affected / 29 at risk

Adverse event: M/A
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 16 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 6 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: AST/ALT
Serious: no
Organ System: Investigations
Frequency: 11 affected / 29 at risk

Adverse event: Neurosensory
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: Neuromuscular
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: N/A
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: Mg
Serious: no
Organ System: Investigations
Frequency: 6 affected / 29 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: Phos
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: HTN
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: ocular
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: desquam skin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Back pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Breast pain
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: gr 3 ulcerative colitis exacerbation with and without gr 1 fever)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Sepsis 3, PLT 1, K, 1, Ca, 1, Hgb1, Phos, 3, Pruritis, 1
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: cardiac ischemia gr 2,
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: gr 3 abd pain, gr 1 nausea, gr 2 vomitting
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: impt medical event(gr2) abnormal stress test need for cardiac cath
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 9 affected / 19 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: plt
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: HGB
Serious: no
Organ System: Investigations
Frequency: 12 affected / 19 at risk

Adverse event: M/A
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 7 affected / 19 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 14 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 11 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 10 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 3 affected / 19 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Investigations
Frequency: 5 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 7 affected / 19 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Investigations
Frequency: 9 affected / 19 at risk

Adverse event: AST/ALT
Serious: no
Organ System: Investigations
Frequency: 6 affected / 19 at risk

Adverse event: Neurosensory
Serious: no
Organ System: Investigations
Frequency: 17 affected / 19 at risk

Adverse event: Neuromuscular
Serious: no
Organ System: Investigations
Frequency: 9 affected / 19 at risk

Adverse event: N/A
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Investigations
Frequency: 6 affected / 19 at risk

Adverse event: Mg
Serious: no
Organ System: Investigations
Frequency: 5 affected / 19 at risk

Adverse event: Blood calcium
Serious: no
Organ System: Investigations
Frequency: 7 affected / 19 at risk

Adverse event: Phos
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Frequency: 7 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Investigations
Frequency: 3 affected / 19 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: ocular
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Investigations
Frequency: 5 affected / 19 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: mood alteration
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: chelitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Blood albumin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Hypouricaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk