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Vidaza (Azacitidine Subcutaneous) - Sepsis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Sepsis (163)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vidaza (Azacitidine Subcutaneous) where reactions include sepsis. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 163   Next >>

Possible Vidaza side effects in 80 year old male

Reported by a physician from Germany on 2012-08-24

Patient: 80 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Pneumonia, Cardiac Failure, Sepsis, Pulmonary Oedema, Pancytopenia, Abscess Sweat Gland

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 145 milligram
    Start date: 2012-02-20
    End date: 2012-02-24

Vidaza
    Dosage: 145 milligram
    Start date: 2012-03-26
    End date: 2012-03-27

Vidaza
    Dosage: 145 milligram
    Start date: 2012-02-27
    End date: 2012-02-28

Vidaza
    Dosage: 145 milligram
    Start date: 2012-03-19
    End date: 2012-03-23

Other drugs received by patient: Esidrix; Flutrimazole; Ramipril; Lorazepam; Xylocaine; Prednisolone; Pantoprazole; Polyethylene Glycol; Sodium Chloride; Ondansetron; Carvedilol; Ondansetron; Torsemide



Possible Vidaza side effects in

Reported by a physician from Japan on 2012-08-21

Patient: , weighing 71.0 kg (156.2 pounds)

Reactions: Pneumonia, Sepsis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-10-31
    End date: 2011-11-04

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-09-12
    End date: 2011-09-16

Other drugs received by patient: Meropenem; Doripenem Monohydrate; Zoloft; Purnoside; Platelets; Serotone; Raden; Meilax; Belmaton; Funguard; Bezatol SR; Firstcin; RED Blood Cells; Magmitt; Ledolper



Possible Vidaza side effects in male

Reported by a physician from Japan on 2012-08-21

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Blast Cell Count Increased, Sepsis, Anaemia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Indication: Myelodysplastic Syndrome
    Start date: 2011-05-16
    End date: 2011-05-22

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-08-25
    End date: 2011-08-29

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-07-05
    End date: 2011-07-09

Other drugs received by patient: Olmesartan Medoxomil; Lasix; Firstcin; Belmaton; Whole Blood; Firstcin; Serotone; Calblock; Famotidine; Fosmicin-S; Funguard; Cytarabine; Serotone; Serotone; Acrasin; Urinorm; Omegacin



Possible Vidaza side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient:

Reactions: Pneumonia, Gastrointestinal Disorder, Sepsis, Cardiac Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in

Reported by a physician from Italy on 2012-08-17

Patient:

Reactions: Pneumonia, Acute Myeloid Leukaemia, Anaemia, Recurrent Cancer, Constipation, Injection Site Erythema, Sepsis, Neutropenia, Thrombocytopenia, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 100 milligram
    Start date: 2005-10-01
    End date: 2011-08-01

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2005-10-01
    End date: 2011-08-01



Possible Vidaza side effects in 80 year old male

Reported by a physician from Germany on 2012-08-17

Patient: 80 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Pneumonia, Cardiac Failure, Sepsis, Pulmonary Oedema, Pancytopenia, Abscess Sweat Gland

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 145 milligram
    Start date: 2012-02-20
    End date: 2012-02-28

Vidaza
    Dosage: 145 milligram
    Start date: 2012-03-19
    End date: 2012-03-27

Other drugs received by patient: Vancomycin; Meropenem; Armodafinil; Diuretics; Nitrate; Morphine



Possible Vidaza side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male, weighing 58.5 kg (128.7 pounds)

Reactions: Pneumonia, Hepatotoxicity, Sepsis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Midostaurin
    Dosage: 150 milligram
    Start date: 2012-07-23
    End date: 2012-07-29

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-06-18
    End date: 2012-06-24

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-07-16
    End date: 2012-07-22

Other drugs received by patient: Amlodipine; Ativan; Metformin Hydrochloride; Humulin R; Tylenol; Clotrimazole; Fluconazole; Ondansetron; Lantus; Levothyroxine Sodium; Humalog; Fluids; Acyclovir; Famotidine



Possible Vidaza side effects in 66 year old female

Reported by a physician from Japan on 2012-08-14

Patient: 66 year old female, weighing 49.0 kg (107.8 pounds)

Reactions: Bronchopulmonary Aspergillosis, Sepsis, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Laxoberon; Kativ-N; Folic Acid; Polaramine; Antibiotics; Alosenn; Lasix; Pyrinazin; Vancomycin; NEO-Minophagen C; Levofloxacin; Sodium Bicarbonate; Meropenem; Diflucan; Maglax; Valtrex



Possible Vidaza side effects in male

Reported by a physician from Japan on 2012-08-14

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-08-08
    End date: 2011-08-12

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-03-19
    End date: 2012-03-23

Vidaza
    Dosage: 75 milligram/sq. meter
    Indication: Myelodysplastic Syndrome
    Start date: 2011-07-11
    End date: 2011-07-15

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-04-19
    End date: 2012-04-23

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-05-14
    End date: 2012-05-18

Other drugs received by patient: Garenoxacin Mesylate; Magmitt; RBC Transfusion; Armodafinil; Ramelteon



Possible Vidaza side effects in

Reported by a individual with unspecified qualification from Austria on 2012-08-13

Patient:

Reactions: Lung Infection, Myocardial Ischaemia, Pyrexia, Device Related Infection, Neoplasm, Cardiac Disorder, Upper Respiratory Tract Infection, Fracture, Herpes Simplex, Metabolic Disorder, Blood Pressure Abnormal, Anaemia, Gastrointestinal Disorder, NO Therapeutic Response, Nervous System Disorder, Neutropenia, Abscess, Haemorrhage, Pain, Left Ventricular Failure, Constipation, Liver Disorder, Disease Progression, Death, Fatigue, Injection Site Reaction, Thrombocytopenia, Renal Disorder, Vomiting, Nausea, Urinary Tract Infection, Acute Myeloid Leukaemia, Febrile Neutropenia, Arrhythmia, Gastrointestinal Infection, Embolism, Diarrhoea, Sepsis, Cytomegalovirus Infection, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Start date: 2007-02-01
    End date: 2012-02-01

Vidaza
    Start date: 2007-02-01
    End date: 2011-07-01

Other drugs received by patient: Erythropoiesis Stimulating Agents; Integrative Cancer Treatment; Neupogen



Possible Vidaza side effects in female

Reported by a physician from Japan on 2012-08-10

Patient: female, weighing 39.0 kg (85.8 pounds)

Reactions: Pneumonia, Sepsis, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-05

Vidaza
    Dosage: 75 milligram/sq. meter
    Indication: Myelodysplastic Syndrome
    Start date: 2011-08-04
    End date: 2011-08-08

Other drugs received by patient: Motilium; Protecadin; Sulfamethoxazole and Trimethoprim; Lansoprazole; Armodafinil; Methycool; Isoniazid; S Adchnon; Aldactone; Allopurinol; Neuquinon; Itraconazole; Depas; Polaramine; LAC-B; Magmitt; Lasix



Possible Vidaza side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07

Patient: 65 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Hypersensitivity, Pneumonia, Anaemia, General Physical Health Deterioration, Disease Progression, Fatigue, Sepsis, Granulocytopenia, Depression, Asthenia, Thrombocytopenia, Leukopenia, Decreased Appetite, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    End date: 2011-10-10

Vidaza
    Start date: 2010-09-29

Vidaza
    Start date: 2011-02-14
    End date: 2011-02-28

Vidaza
    Start date: 2011-04-04
    End date: 2011-04-11

Vidaza
    Start date: 2011-08-15
    End date: 2011-08-25



Possible Vidaza side effects in 59 year old female

Reported by a physician from Germany on 2012-08-07

Patient: 59 year old female, weighing 67.0 kg (147.4 pounds)

Reactions: Haemoglobin Abnormal, Myelodysplastic Syndrome, Pancytopenia, Platelet Disorder, White Blood Cell Disorder, Fatigue, Sepsis, Granulocytes Abnormal, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Neupogen; Ciprofloxacin



Possible Vidaza side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07

Patient: 71 year old male, weighing 71.9 kg (158.2 pounds)

Reactions: Gingival Bleeding, Nausea, Mouth Haemorrhage, Acute Myeloid Leukaemia, General Physical Health Deterioration, Haemoglobin Decreased, Fatigue, Sepsis, Platelet Count Decreased, Blood Creatinine Increased, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: RED Blood Cells



Possible Vidaza side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07

Patient: 71 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Sepsis, Injection Site Reaction, Diverticulitis, Urinary Tract Infection, Febrile Neutropenia, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Platelets; Platelets; RED Blood Cells; RED Blood Cells



Possible Vidaza side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07

Patient: 54 year old female, weighing 102.0 kg (224.4 pounds)

Reactions: Abdominal Hernia, Nausea, Sepsis, Granulocytopenia, General Physical Health Deterioration, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-05-23
    End date: 2011-05-27

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-04-27

Other drugs received by patient: RED Blood Cells, Concentrated



Possible Vidaza side effects in 78 year old male

Reported by a physician from Germany on 2012-08-07

Patient: 78 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Anaemia, Skin Toxicity, Pyrexia, Platelet Disorder, Syncope, White Blood Cell Disorder, Injection Site Reaction, Sepsis, Neutropenia, Skin Necrosis, Infusion Site Abscess

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-07-04
    End date: 2011-07-08

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-07-01

Other drugs received by patient: Sofran; Metoclopramide; Dexamethasone



Possible Vidaza side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-26

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: C-Reactive Protein Increased, Sepsis, Febrile Neutropenia, Pyrexia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-09-22
    End date: 2011-09-22

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-11-24
    End date: 2011-11-25

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-09-21
    End date: 2011-09-21

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-09-26
    End date: 2011-09-30

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-11-28
    End date: 2011-12-02

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-01-23
    End date: 2012-01-27

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-01-30
    End date: 2012-01-31

Other drugs received by patient: Dexamethasone Sodium Phosphate; Dexamethasone Sodium Phosphate; Gran; Aloxi; P N Twin-3; Clindamycin; Gran; Funguard; TPN Electrolytes IN Plastic Container; Primperan TAB; Maxipime; Urso 250; Hicaliq RF; Minocycline HCL; Amsulmylan; Zosyn; Carbenin; Cefotiam Hydrochloride; Maxipime; Amlodipine; Flumarin; Doripenem Monohydrate; Amikacin Sulfate; P N Twin-1; Vancomycin Hydrochloride; Albumin (Human); Irsogladine Maleate; TPN Electrolytes IN Plastic Container; Emend; Kytril; Gasmotin; P N Twin-2; Levofloxacin; Senna-Mint WAF; Daikenchuto



Possible Vidaza side effects in male

Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-07-24

Patient: male, weighing 68.5 kg (150.7 pounds)

Reactions: Endocarditis Bacterial, Sepsis, Bacterial Sepsis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Vidaza
    Dosage: 88.5 milligram/sq. meter
    Start date: 2012-03-01
    End date: 2012-03-02

Vidaza
    Indication: Myelodysplastic Syndrome
    Start date: 2011-10-31

Other drugs received by patient: Allapinina; Vfend; Albumin (Human); Allapinina; Lasix; Lasix; Albumin (Human); Vfend; Neuromultivit; Sulperazone



Possible Vidaza side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23

Patient:

Reactions: Death, Haemorrhage, Sepsis, Pancytopenia, Hepatic Failure, Treatment Failure, Polychondritis, Cerebrovascular Accident, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in female

Reported by a physician from United States on 2012-07-16

Patient: female

Reactions: Sepsis, Acute Myeloid Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 50 milligram
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-21

Vidaza
    Dosage: 154 milligram
    Start date: 2012-05-25
    End date: 2012-05-31

Other drugs received by patient: Platelets; Ducosate; Miralax; Lasix; Allopurinol; Potassium Chloride; Vitamin B-12; Vitamin D; Insulin; NS Bolus; Vancomycin; Bisacodyl; Dexamethasone; Filgrastim; Glutose; Senna-Mint WAF; Insulin; Insulin; Magnesium Hydroxide TAB; Zosyn; Activase; Metoclopramide; Acetaminophen; Compazine; Insulin Lispro; Triple MIX; Anusol; Cefepime; RED Blood Cells; Reglan; Magnesium Citrate; Insulin Lispro; Dextrose; Pantoprazole; Calcium; Ondansetron HCL; Morphine



Possible Vidaza side effects in female

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

Patient: female

Reactions: Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-12

Patient:

Reactions: Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in 75 year old male

Reported by a physician from Germany on 2012-07-06

Patient: 75 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Sepsis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Cytarabine
    Start date: 2012-05-22
    End date: 2012-05-26

Etoposide

Idarubicin HCL

Lenograstim

Vidaza



Possible Vidaza side effects in

Reported by a individual with unspecified qualification from Austria on 2012-07-06

Patient:

Reactions: Myocardial Ischaemia, Lung Infection, Pyrexia, Device Related Infection, Neoplasm, Cardiac Disorder, Herpes Simplex, Fracture, Upper Respiratory Tract Infection, Metabolic Disorder, Blood Pressure Abnormal, Anaemia, Gastrointestinal Disorder, NO Therapeutic Response, Nervous System Disorder, Abscess, Neutropenia, Haemorrhage, Pain, Constipation, Left Ventricular Failure, Disease Progression, Liver Disorder, Death, Fatigue, Injection Site Reaction, Thrombocytopenia, Renal Disorder, Vomiting, Nausea, Acute Myeloid Leukaemia, Urinary Tract Infection, Febrile Neutropenia, Arrhythmia, Gastrointestinal Infection, Embolism, Diarrhoea, Sepsis, Cytomegalovirus Infection, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Start date: 2007-02-01
    End date: 2012-02-01

Vidaza
    Start date: 2007-02-01
    End date: 2011-07-01

Other drugs received by patient: Neupogen; Erythropoiesis Stimulating Agents; Integrative Cancer Treatment



Possible Vidaza side effects in male

Reported by a physician from Japan on 2012-07-05

Patient: male

Reactions: Sepsis, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-06-21
    End date: 2011-06-24

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-04-25
    End date: 2011-04-28

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-05-19
    End date: 2011-05-20

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-04-20
    End date: 2011-04-22

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-05-23
    End date: 2011-05-27

Other drugs received by patient: Flumarin; Mashi-NIN-GAN; Maxipime; Meropenem; Amphotericin B; Venilon; Neoamiyu; Voltaren; Aspirin; Candesartan Cilexetil; Sennoside; Maxipime; Micafungin Sodium; Mucodyne; Lansoprazole; Cefotiam Hydrochloride; Meropenem; Gran; Albumin (Human); Albumin (Human); Doxazosin Mesylate; Comelian; Teleminsoft; Granisetron; Dexamethasone Sodium Phosphate; Amsulmylan; Neupogen; Venilon; Albumin (Human); Albumin (Human); Albumin (Human); Elemenmic; Acmain; Amlodipine Besylate; Trichlormethiazide; Levofloxacin; Albumin (Human)



Possible Vidaza side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-05

Patient: male, weighing 68.0 kg (149.6 pounds)

Reactions: Gastrointestinal Haemorrhage, Disseminated Intravascular Coagulation, Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Indication: Myelodysplastic Syndrome
    Start date: 2011-07-27
    End date: 2011-08-02

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-08-19
    End date: 2011-08-25

Other drugs received by patient: Maxipime; Meropenem; Funguard; Vancomycin; Meropenem; Recomodulin; Vfend; Famotidine; Wystal; Nonthron; Nisseki Polyglobin-N; Neutrogin; Neutrogin; Granisetron; Funguard; Ambisome



Possible Vidaza side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-03

Patient: 68 year old female

Reactions: Sepsis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Metoclopramide; Aspirin; Cotrim DS; Furosemide; Amphotericin B; Pantoprazole; Palladone; Irbesartan and Hydrochlorothiazide



Possible Vidaza side effects in female

Reported by a physician from Japan on 2012-06-29

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: White Blood Cell Count Decreased, Haemoglobin Decreased, Renal Impairment, Hyperkalaemia, Disseminated Intravascular Coagulation, Sepsis, Platelet Count Decreased, Hyponatraemia, Pulmonary Thrombosis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Maxipime; Neutrogin; Recomodulin; Itraconazole; Solu-Cortef; Prednisolone; Neoral; Neuart; Futhan; Doripenem Monohydrate; Rabeprazole Sodium; Omegacin; Prodif; Famotidine



Possible Vidaza side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-26

Patient: 52 year old female, weighing 103.5 kg (227.7 pounds)

Reactions: Confusional State, Atelectasis, Haemorrhage Intracranial, Multi-Organ Failure, Respiratory Failure, Sepsis, Colitis, Hypoxia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gemtuzumab
    Dosage: 3 milligram/sq. meter
    Start date: 2012-02-10
    End date: 2012-02-17

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-02-10
    End date: 2012-02-16

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-02-10
    End date: 2012-02-16

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2012-02-10
    End date: 2012-02-18

Other drugs received by patient: Ribavirin; Steroids



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