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Afinitor (Everolimus) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (124)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Afinitor (Everolimus) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 124   Next >>

Possible Afinitor side effects in female

Reported by a physician from Canada on 2012-08-23

Patient: female, weighing 79.4 kg (174.7 pounds)

Reactions: Sick Sinus Syndrome, Device Related Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Afinitor
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Carbamazepine
    Dosage: 200 mg, tid
    Indication: Convulsion
    Start date: 2001-01-01

Cymbalta
    Dosage: unk
    Indication: Depression
    Start date: 2012-02-10

Insulin
    Dosage: 20 uam 4 upm
    Indication: Diabetes Mellitus
    Start date: 2006-10-01

Levothyroxine Sodium
    Dosage: 150 mg qpm
    Indication: Hypothyroidism
    Start date: 2008-01-01

Lipitor
    Indication: Hypertriglyceridaemia

Lipitor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2001-01-01

Placebo
    Dosage: code not broken
    Administration route: Oral
    Start date: 2012-07-19
    End date: 2012-08-01

Placebo
    Dosage: code not broken
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Trazodone Hydrochloride
    Dosage: 100 mg, qhs
    Indication: Depression
    Start date: 2008-01-01

Wellbutrin
    Dosage: 150 mg qpm
    Indication: Depression
    Start date: 2008-01-01



Possible Afinitor side effects in female

Reported by a physician from Mexico on 2012-08-22

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Hypovolaemic Shock, Cerebrovascular Accident, Cerebral Ischaemia, Hemiplegia, Thrombocytopenia, Acute Respiratory Failure, Hypovolaemia, Epistaxis

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-28

Comparator Trastuzumab
    Dosage: 120 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26

Paclitaxel
    Dosage: 192 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26



Possible Afinitor side effects in female

Reported by a physician from South Africa on 2012-08-22

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Diabetic Ulcer, Hyperglycaemia, Hyponatraemia, Neoplasm Progression, Hypokalaemia, Renal Impairment, Neoplasm Malignant, Skin Lesion, Sepsis, Dehydration, Cardiac Arrest, Pneumonitis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Comparator Trastuzumab
    Dosage: 2 mg/kg, qw
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Paclitaxel
    Dosage: 80 mg/m2, qw
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Other drugs received by patient: Zamanon; Marinol; Metformin; Maxolon



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: Pain, Kidney Transplant Rejection, Constipation, Hypoxia, Inappropriate Antidiuretic Hormone Secretion, Decreased Appetite, Metabolic Acidosis, Dyspnoea, Hyperglycaemia, Anaemia, Hyponatraemia, Renal Failure, Lung Disorder, Diarrhoea, Metastases To Spine, Dehydration, Radiation Pneumonitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Prednisone; Furosemide; Metoprolol Tartrate; Radiation Therapy; Magnesium Oxide; Glipizide; Lipitor



Possible Afinitor side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 89.2 kg (196.2 pounds)

Reactions: Abdominal Infection, Intestinal Perforation, Hepatic Infection, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Colorectal Cancer
    Start date: 2012-08-09

Fluorouracil
    Dosage: 1200 mg/m2, qd
    Indication: Colorectal Cancer
    Start date: 2012-08-09
    End date: 2012-08-11

Other drugs received by patient: Avastin; Diclofenac; Avastin; Fentanyl; Finasteride; Compazine; Emla; Acyclovir; Oxaliplatin; Ambien; Zofran; Ibuprofen; Baclofen



Possible Afinitor side effects in female

Reported by a physician from Korea, Republic of on 2012-08-17

Patient: female, weighing 51.8 kg (114.0 pounds)

Reactions: Confusional State, Blood Urea Increased, Blood Calcium Increased, Azotaemia, Blood Creatinine Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Norvasc; Fosamax; Irbesartan; Insulin



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male, weighing 89.2 kg (196.2 pounds)

Reactions: Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Colorectal Cancer
    Start date: 2012-08-09

Fluorouracil
    Dosage: 1200 mg/m2, qd
    Indication: Colorectal Cancer
    Start date: 2012-08-09
    End date: 2012-08-11

Other drugs received by patient: Oxaliplatin; Diclofenac; Acyclovir; Ambien; Finasteride; Avastin; Emla; Baclofen



Possible Afinitor side effects in female

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

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Cardiac Arrest, Blood Glucose Increased

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, unk
    Indication: Breast Cancer Metastatic
    Start date: 2011-09-08
    End date: 2012-07-12

Letrozole
    Dosage: 2.5 mg, unk
    Indication: Breast Cancer Metastatic
    Start date: 2011-09-08
    End date: 2012-08-04

Other drugs received by patient: Glucophage; Actonel; Vitamin D; Vitamin B-12



Possible Afinitor side effects in female

Reported by a physician from Israel on 2012-08-09

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Cardiac Arrest

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, unk
    Indication: Breast Cancer Metastatic
    Start date: 2011-09-08
    End date: 2012-07-12

Letrozole
    Dosage: 2.5 mg, unk
    Indication: Breast Cancer Metastatic
    Start date: 2011-09-08
    End date: 2012-08-04

Other drugs received by patient: Vitamin D; Vitamin B-12; Glucophage



Possible Afinitor side effects in female

Reported by a physician from Greece on 2012-08-09

Patient: female

Reactions: Metastases To Chest Wall, Neoplasm Malignant, Hypercapnia, Neoplasm Progression, Pleural Effusion, Pyrexia, Somnolence, Lethargy

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-05-21
    End date: 2012-07-29

Buspirone Hydrochloride
    Indication: Insomnia
    Start date: 2012-07-27
    End date: 2012-07-29

Other drugs received by patient: Amoxil; T4; Aromasin; Exelon; Dufalone



Possible Afinitor side effects in female

Reported by a physician from Israel on 2012-08-08

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 5 mg, unk
    Indication: Breast Cancer Metastatic
    Start date: 2011-09-08
    End date: 2012-07-12

Letrozole
    Dosage: 2.5 mg, unk
    Indication: Breast Cancer Metastatic
    Start date: 2011-09-08
    End date: 2012-08-04

Other drugs received by patient: Glucophage; Vitamin B-12; Vitamin D



Possible Afinitor side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male

Reactions: Pneumonia, Metabolic Acidosis, Radiation Injury, Hyperglycaemia, Metastatic Pain, Hyponatraemia, Transplant Rejection, Constipation, Renal Failure, Diarrhoea, Dehydration, Hypoxia, Inappropriate Antidiuretic Hormone Secretion, Blood Creatinine Increased, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Prednisone; Metoprolol Tartrate; Radiation Therapy; Lipitor; Glipizide; Magnesium Oxide; Furosemide



Possible Afinitor side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-06

Patient: female, weighing 79.4 kg (174.7 pounds)

Reactions: Sick Sinus Syndrome, Device Related Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Afinitor
    Dosage: double blinded
    Administration route: Oral
    End date: 2012-08-01

Blinded NO Treatment Received
    Dosage: double blinded
    Administration route: Oral
    End date: 2012-08-01

Blinded NO Treatment Received
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Carbamazepine
    Dosage: 200 mg, tid
    Indication: Convulsion
    Start date: 2001-01-01

Cymbalta
    Dosage: unk
    Indication: Depression
    Start date: 2012-02-10

Insulin
    Dosage: 20 uam 4 upm
    Indication: Diabetes Mellitus
    Start date: 2006-10-01

Levothyroxine Sodium
    Dosage: 150 mg qpm
    Indication: Hypothyroidism
    Start date: 2008-01-01

Lipitor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2001-01-01

Lipitor
    Indication: Hypertriglyceridaemia

Placebo
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Placebo
    Dosage: double blinded
    Administration route: Oral
    End date: 2012-08-01

Trazodone Hydrochloride
    Dosage: 100 mg, qhs
    Indication: Depression
    Start date: 2008-01-01

Wellbutrin
    Dosage: 150 mg qpm
    Indication: Depression
    Start date: 2008-01-01



Possible Afinitor side effects in female

Reported by a physician from Korea, Republic of on 2012-08-03

Patient: female, weighing 51.8 kg (114.0 pounds)

Reactions: Confusional State, Blood Urea Increased, Blood Calcium Increased, Blood Creatinine Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Fosamax; Norvasc; Irbesartan; Insulin



Possible Afinitor side effects in female

Reported by a physician from Korea, Republic of on 2012-08-02

Patient: female

Reactions: Confusional State, Blood Urea Increased, Blood Calcium Increased, Metastases To Central Nervous System, Blood Creatinine Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Irbesartan; Insulin



Possible Afinitor side effects in 79 year old female

Reported by a physician from Greece on 2012-08-01

Patient: 79 year old female

Reactions: Pyrexia, Somnolence, Lethargy

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Indication: Breast Cancer
    Start date: 2012-05-21
    End date: 2012-07-29

Buspirone Hydrochloride
    Dosage: unk
    Indication: Insomnia
    Start date: 2012-07-27
    End date: 2012-07-29

Other drugs received by patient: Aromasin; Amoxil; Dufalone; T4; Exelon



Possible Afinitor side effects in male

Reported by a consumer/non-health professional from France on 2012-07-30

Patient: male, weighing 87.0 kg (191.4 pounds)

Reactions: White Blood Cell Count Decreased, Enterobacter Infection, Pneumonia, Hypotension, Candida Sepsis, Pyrexia, Aplasia, Haemoglobin Decreased, C-Reactive Protein Increased, Sepsis, Bone Marrow Failure, Platelet Count Decreased, Aplastic Anaemia, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2008-03-10
    End date: 2008-03-10

Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2008-03-16
    End date: 2008-03-16

Daunorubicin Hydrochloride
    Dosage: 360 mg/ day
    Indication: Acute Myeloid Leukaemia
    Start date: 2008-03-10
    End date: 2008-03-12

Other drugs received by patient: Zofran; Cytarabine; Chemotherapeutics NOS



Possible Afinitor side effects in female

Reported by a physician from Mexico on 2012-07-30

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Hypovolaemic Shock, Cerebrovascular Accident, Cerebral Ischaemia, Hemiplegia, Acute Respiratory Failure, Thrombocytopenia, Epistaxis, Hypovolaemia

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-28

Comparator Trastuzumab
    Dosage: 120 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26

Paclitaxel
    Dosage: 192 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26



Possible Afinitor side effects in 63 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 63 year old female

Reactions: Rash

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Afinitor



Possible Afinitor side effects in female

Reported by a physician from United States on 2012-07-27

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Pneumonia, Dyspnoea, Anaemia, Tachycardia, Pyrexia, Multi-Organ Failure, Urosepsis, Acute Respiratory Distress Syndrome, Oedema, Hypoxia, Escherichia Infection, Asthenia, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: code not broken
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-18

Afinitor
    Dosage: unk

Comparator Trastuzumab
    Dosage: 137 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-10

Paclitaxel
    Dosage: 142 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-03

Vancomycin
    Dosage: 1 g, q12h
    Start date: 2011-03-16

Other drugs received by patient: Duoneb; Lovenox; Metoprolol Tartrate; Xanax; Vicodin; Benadryl; Protonix



Possible Afinitor side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-20

Patient: female, weighing 79.4 kg (174.7 pounds)

Reactions: Sick Sinus Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Afinitor
    Dosage: double blinded
    Administration route: Oral

Blinded NO Treatment Received
    Dosage: double blinded
    Administration route: Oral

Blinded NO Treatment Received
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Carbamazepine
    Dosage: 200 mg, tid
    Indication: Convulsion
    Start date: 2001-01-01

Cymbalta
    Dosage: unk
    Indication: Depression
    Start date: 2012-02-10

Insulin
    Dosage: 20 uam 4 upm
    Indication: Diabetes Mellitus
    Start date: 2006-10-01

Levothyroxine Sodium
    Dosage: 150 mg qpm
    Indication: Hypothyroidism
    Start date: 2008-01-01

Lipitor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2001-01-01

Lipitor
    Indication: Hypertriglyceridaemia

Placebo
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Placebo
    Dosage: double blinded
    Administration route: Oral

Trazodone Hydrochloride
    Dosage: 100 mg, qhs
    Indication: Depression
    Start date: 2008-01-01

Wellbutrin
    Dosage: 150 mg qpm
    Indication: Depression
    Start date: 2008-01-01



Possible Afinitor side effects in female

Reported by a physician from United States on 2012-07-17

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Dyspnoea, Pneumonia, Tachycardia, Anaemia, Pyrexia, Multi-Organ Failure, Hypoxia, Urosepsis, Oedema, Escherichia Infection, Asthenia, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk

Afinitor
    Dosage: code not broken
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-18

Comparator Trastuzumab
    Dosage: 137 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-10

Paclitaxel
    Dosage: 142 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-03

Vancomycin
    Dosage: 1 g, q12h
    Start date: 2011-03-16

Other drugs received by patient: Duoneb; Lovenox; Vicodin; Xanax; Metoprolol Tartrate; Benadryl; Protonix



Possible Afinitor side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-13

Patient: female, weighing 79.4 kg (174.7 pounds)

Reactions: Sick Sinus Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Blinded NO Treatment Received
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Carbamazepine
    Dosage: 200 mg, tid
    Indication: Convulsion
    Start date: 2001-01-01

Cymbalta
    Dosage: unk
    Indication: Depression
    Start date: 2012-02-10

Insulin
    Dosage: 20 uam 4 upm
    Indication: Diabetes Mellitus
    Start date: 2006-10-01

Levothyroxine Sodium
    Dosage: 150 mg qpm
    Indication: Hypothyroidism
    Start date: 2008-01-01

Lipitor
    Indication: Hypertriglyceridaemia

Lipitor
    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2001-01-01

Placebo
    Dosage: double blinded
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-24
    End date: 2012-07-11

Trazodone Hydrochloride
    Dosage: 100 mg, qhs
    Indication: Depression
    Start date: 2008-01-01

Wellbutrin
    Dosage: 150 mg qpm
    Indication: Depression
    Start date: 2008-01-01



Possible Afinitor side effects in female

Reported by a physician from United States on 2012-07-12

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Pneumonia, Dyspnoea, Tachycardia, Anaemia, Pyrexia, Multi-Organ Failure, Urosepsis, Hypoxia, Oedema, Escherichia Infection, Asthenia, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: code not broken
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-18

Afinitor
    Dosage: unk

Comparator Trastuzumab
    Dosage: 137 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-10

Paclitaxel
    Dosage: 142 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-03

Vancomycin
    Dosage: 1 g, q12h
    Start date: 2011-03-16

Other drugs received by patient: Xanax; Metoprolol Tartrate; Vicodin; Benadryl; Protonix; Duoneb; Lovenox



Possible Afinitor side effects in female

Reported by a physician from United States on 2012-07-05

Patient: female, weighing 139.0 kg (305.8 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor

Other drugs received by patient: Benicar HCT; Tekturna; Carvedilol; Ascorbic Acid; Warfarin Sodium; Iron; Zinc Sulfate



Possible Afinitor side effects in 58 year old male

Reported by a physician from Japan on 2012-07-04

Patient: 58 year old male

Reactions: Dyspnoea, Hypotension, Total Lung Capacity Decreased, Neoplasm Progression, Ventricular Arrhythmia, Arrhythmia, Death, Interstitial Lung Disease, Neoplasm Malignant, Cyanosis, Pneumonia Bacterial, Pleural Effusion, Pneumonitis, Oxygen Saturation Decreased, Lymphocyte Count Decreased

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2011-01-29

Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-05-07
    End date: 2010-11-22

Afinitor
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2010-11-24
    End date: 2011-01-13

Other drugs received by patient: Selbex; Allopurinol; Betamethasone; Mucosolvan; Famotidine; Magmitt; Loxoprofen; Sulfamethoxazole and Trimethoprim; Zometa; Oxycontin



Possible Afinitor side effects in female

Reported by a physician from Mexico on 2012-06-28

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Hypovolaemic Shock, Cerebrovascular Accident, Cerebral Ischaemia, Hemiplegia, Acute Respiratory Failure, Thrombocytopenia, Epistaxis, Hypovolaemia

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-28

Comparator Trastuzumab
    Dosage: 120 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26

Paclitaxel
    Dosage: 192 mg, daily
    Indication: Breast Cancer Metastatic
    Start date: 2010-05-19
    End date: 2010-05-26



Possible Afinitor side effects in female

Reported by a physician from France on 2012-06-27

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Ketoacidosis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, unk
    Start date: 2012-05-02
    End date: 2012-05-28

Som230
    Dosage: 60 mg, unk
    Indication: Pancreatic Neuroendocrine Tumour
    Start date: 2012-05-02
    End date: 2012-05-02

Other drugs received by patient: Candesartan Cilexetil; Ezetimibe; Spiriva; Omeprazole



Possible Afinitor side effects in female

Reported by a physician from South Africa on 2012-06-27

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Diabetic Ulcer, Hyperglycaemia, Neoplasm Progression, Hyponatraemia, Hypokalaemia, Renal Impairment, Fatigue, Neoplasm Malignant, Skin Lesion, Sepsis, Dehydration, Cardiac Arrest, Pneumonitis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Comparator Trastuzumab
    Dosage: 2 mg/kg, qw
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Paclitaxel
    Dosage: 80 mg/m2, qw
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10

Other drugs received by patient: Maxolon; Marinol; Zamanon; Metformin HCL



Possible Afinitor side effects in female

Reported by a physician from South Africa on 2012-06-19

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Diabetic Ulcer, Hyperglycaemia, Hyponatraemia, Neoplasm Progression, Hypokalaemia, Renal Impairment, Fatigue, Neoplasm Malignant, Dehydration, Sepsis, Skin Lesion, Cardiac Arrest, Pneumonitis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10
    End date: 2010-10-04

Comparator Trastuzumab
    Dosage: 2 mg/kg, qw
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10
    End date: 2010-10-04

Paclitaxel
    Dosage: 80 mg/m2, qw
    Indication: Breast Cancer Metastatic
    Start date: 2010-08-10
    End date: 2010-10-04

Other drugs received by patient: Maxolon; Marinol; Zamanon; Metformin HCL



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