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Leukine (Sargramostim) - Death - Suspected Cause - Side Effect Reports

 
 



Index of reports > Death (21)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Leukine (Sargramostim) death. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Leukine side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male

Reactions: Rectal Haemorrhage, Constipation, Cardiac Disorder, Hospitalisation, Granulocytopenia, Inappropriate Antidiuretic Hormone Secretion, Thrombocytopenia, Cardiac Failure Congestive, Pneumonia, Anaemia, Pancytopenia, Atrial Fibrillation, Febrile Neutropenia, Syncope, Embolism, Sepsis, Dehydration, Asthenia, Mantle Cell Lymphoma Recurrent, Leukopenia, Deep Vein Thrombosis, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on day 1
    Indication: Mantle Cell Lymphoma

Cyclophosphamide
    Dosage: on day 1
    Indication: Diffuse Large B-Cell Lymphoma

Doxorubicin HCL
    Dosage: on day 1
    Indication: Diffuse Large B-Cell Lymphoma

Doxorubicin HCL
    Dosage: on day 1
    Indication: Mantle Cell Lymphoma

Leukine
    Dosage: on day 9-15; 250 mcg/m2/day
    Indication: Mantle Cell Lymphoma

Leukine
    Dosage: on day 9-15; 250 mcg/m2/day
    Indication: Diffuse Large B-Cell Lymphoma

Prednisone TAB
    Dosage: on days 1-5
    Indication: Mantle Cell Lymphoma

Prednisone TAB
    Dosage: on days 1-5
    Indication: Diffuse Large B-Cell Lymphoma

Rituximab
    Dosage: on day 15; as infusion
    Indication: Diffuse Large B-Cell Lymphoma

Rituximab
    Dosage: on day 15; as infusion
    Indication: Mantle Cell Lymphoma

Vincristine
    Dosage: on day 1 (maximum dose: 2mg)
    Indication: Diffuse Large B-Cell Lymphoma

Vincristine
    Dosage: on day 1 (maximum dose: 2mg)
    Indication: Mantle Cell Lymphoma



Possible Leukine side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Death, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Death, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Death, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-02

Patient: 67 year old male

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

CPG 7909
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk (day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Investigational Drug
    Dosage: unk()day 1 and day 15
    Start date: 2009-06-23
    End date: 2009-06-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-11
    End date: 2009-06-11

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Leukine
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day15)
    Start date: 2009-06-23
    End date: 2009-06-23

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23



Possible Leukine side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-30

Patient: 67 year old male

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
CPG 7909
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

CPG 7909
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-11
    End date: 2009-06-11

Investigational Drug
    Dosage: unk (day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Investigational Drug
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Investigational Drug
    Dosage: unk()day 1 and day 15
    Start date: 2009-06-23
    End date: 2009-06-23

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Leukine
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Leukine
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11

Other Cytokines and Immunomodulating Agents
    Dosage: unk(day 1 and day15)
    Start date: 2009-06-23
    End date: 2009-06-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-06-23
    End date: 2009-06-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-23
    End date: 2009-07-23

Vaccines
    Dosage: unk(day 1 and day 15)
    Start date: 2009-07-04
    End date: 2009-07-04

Vaccines
    Dosage: unk(day 1 and day 15)
    Indication: Malignant Melanoma
    Start date: 2009-06-11
    End date: 2009-06-11



Possible Leukine side effects in male

Reported by a physician from Germany on 2012-07-13

Patient: male, weighing 94.8 kg (208.5 pounds)

Reactions: Metastatic Malignant Melanoma, Fatigue, Nausea, Anaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 10 mg/kg, q21d
    Indication: Metastatic Malignant Melanoma
    Start date: 2012-05-16
    End date: 2012-06-06

Leukine
    Dosage: 125 mcg/m2, day 1-14,q21 d
    Indication: Metastatic Malignant Melanoma
    Start date: 2012-05-16
    End date: 2012-06-19

Other drugs received by patient: Zofran; Senna-Mint WAF; Colace; Omeprazole; MS Contin; Lipitor; Aspirin; Gabapentin; Miralax; Prozac; Ativan



Possible Leukine side effects in 61 year old male

Reported by a physician from United Kingdom on 2012-06-22

Patient: 61 year old male

Reactions: Vomiting, Pain in Extremity, Aphasia, Muscular Weakness, Pulmonary Embolism, Purpura, Lower Respiratory Tract Infection, Tremor, Fatigue, Diarrhoea

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ima950 (Vaccines)
    Dosage: , 4.96 mg;id, , 4.96 mg;id
    Indication: Glioblastoma
    Start date: 2012-02-21
    End date: 2012-02-21

Ima950 (Vaccines)
    Dosage: , 4.96 mg;id, , 4.96 mg;id
    Indication: Glioblastoma
    Start date: 2012-01-03
    End date: 2012-01-03

Leukine
    Dosage: 75 mcg;id, 75 mcg;id
    Indication: Glioblastoma
    Start date: 2012-02-21
    End date: 2012-02-21

Leukine
    Dosage: 75 mcg;id, 75 mcg;id
    Indication: Glioblastoma
    Start date: 2012-01-03
    End date: 2012-01-03

Temozolomide
    Dosage: 200 mg;po 200 mg/m2;po
    Administration route: Oral
    Indication: Glioblastoma
    Start date: 2012-02-28
    End date: 2012-03-03

Other drugs received by patient: Omeprazole; Gliclazide; Clobazam; Levetiracetam; Dexamethasone



Possible Leukine side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: 61 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Fatigue, Embolism, Neoplasm Malignant, Hypotension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: day 1 c3 delayed until 01sep11 start dt:1sep11 last dose:1sep11,4aug11,758mg resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15
    End date: 2011-10-06

Leukine
    Dosage: c3 delayed until 01sep11 start dt:1sep11 last dose:14sep11(3500mg,17aug11 resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15
    End date: 2011-10-06



Possible Leukine side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-28

Patient: 61 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Fatigue, Neoplasm Malignant, Embolism, Hypotension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: day 1 c3 delayed until 01sep11 start dt:1sep11 last dose:1sep11 resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15

Leukine
    Dosage: c3 delayed until 01sep11 start dt:1sep11 last dose:14sep11(3500mcg) resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15



Possible Leukine side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: 61 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Fatigue, Embolism, Neoplasm Malignant, Hypotension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: day 1 c3 delayed until 01sep11 start dt:1sep11 last dose:1sep11 resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15

Leukine
    Dosage: c3 delayed until 01sep11 start dt:1sep11 last dose:14sep11(3500mcg) resumed on 22sep11
    Indication: Malignant Melanoma
    Start date: 2011-07-15



Possible Leukine side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-02-26

Patient: 52 year old female, weighing 76.0 kg (167.2 pounds)

Reactions: Sepsis, Adrenal Insufficiency, Pyrexia, Oropharyngeal Pain, Cardiac Arrest, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last administered dose 18nov11 on dy1 q12wks
    Indication: Malignant Melanoma
    Start date: 2011-06-24

Leukine
    Dosage: last administered date 20nov11
    Indication: Malignant Melanoma
    Start date: 2011-06-24

Other drugs received by patient: Effexor; Synthroid; Multi-Vitamin; Acetaminophen



Possible Leukine side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-02-20

Patient: 52 year old female, weighing 76.0 kg (167.2 pounds)

Reactions: Sepsis, Adrenal Insufficiency, Pyrexia, Oropharyngeal Pain, Cardiac Arrest, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last administered dose 18nov11 on dy1 q12wks
    Indication: Malignant Melanoma
    Start date: 2011-06-24

Leukine
    Dosage: last administered date 20nov11
    Indication: Malignant Melanoma
    Start date: 2011-06-24

Other drugs received by patient: Effexor; Acetaminophen; Synthroid; Multi-Vitamin



Possible Leukine side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-02-05

Patient: 77 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Large Intestine Perforation, Embolism, Diarrhoea, Colitis Ulcerative, Pseudomembranous Colitis, Platelet Count Decreased, Rash, Large Intestinal Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-16

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-19



Possible Leukine side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2011-12-15

Patient: 63 year old male, weighing 94.0 kg (206.8 pounds)

Reactions: Multi-Organ Failure, Dyspnoea, Hyperkalaemia, Neoplasm Malignant, Hyponatraemia, Neutrophil Count Decreased, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last dose on 12aug11 12aug11 cycle 2
    Indication: Malignant Melanoma
    Start date: 2011-07-21

Leukine
    Dosage: last dose on 26aug11
    Indication: Malignant Melanoma
    Start date: 2011-07-21

Vancomycin
    Indication: Dermatitis
    Start date: 2011-08-22
    End date: 2011-08-24

Other drugs received by patient: Mirtazapine; Milk OF Magnesia TAB; Pepcid; Prinzide; Dilaudid; Temazepam



Possible Leukine side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2011-12-14

Patient: 52 year old female, weighing 76.0 kg (167.2 pounds)

Reactions: Sepsis, Adrenal Insufficiency, Oropharyngeal Pain, Pyrexia, Cardiac Arrest, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last administered dose 18nov11 on dy1 q12wks
    Indication: Malignant Melanoma
    Start date: 2011-06-24

Leukine
    Dosage: last administered date 20nov11
    Indication: Malignant Melanoma

Other drugs received by patient: Synthroid; Effexor; Acetaminophen



Possible Leukine side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-13

Patient: 52 year old female, weighing 76.0 kg (167.2 pounds)

Reactions: Sepsis, Adrenal Insufficiency, Oropharyngeal Pain, Pyrexia, Cardiac Arrest, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last administered dose 18nov11 on dy1 q12wks
    Indication: Malignant Melanoma
    Start date: 2011-06-24

Leukine
    Dosage: last administered date 20nov11
    Indication: Malignant Melanoma

Other drugs received by patient: Acetaminophen; Effexor; Synthroid



Possible Leukine side effects in

Reported by a consumer/non-health professional from Germany on 2011-12-07

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: 76 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Large Intestine Perforation, Embolism, Diarrhoea, Platelet Count Decreased, Rash, Large Intestinal Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-16

Leukine
    Indication: Malignant Melanoma
    Start date: 2011-08-04
    End date: 2011-09-19



Possible Leukine side effects in

Reported by a consumer/non-health professional from Germany on 2011-12-02

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Leukine



Possible Leukine side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-04

Patient: 75 year old male, weighing 79.0 kg (173.8 pounds)

Reactions: Neoplasm Malignant, Cardiac Arrest, Lymphocyte Count Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Ipilimumab
    Dosage: last admin: 6jul11. no of courses: 3.
    Indication: Malignant Melanoma
    Start date: 2011-05-27
    End date: 2011-07-06

Leukine
    Dosage: last admin: 19jul11. no of courses: 3. c3: 3500 mcg
    Indication: Malignant Melanoma
    Start date: 2011-05-27
    End date: 2011-07-19

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