Index of reports
> All Cases (4019)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Methotrexate all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 4019 Next >>
Possible Methotrexate side effects in female
Reported by a physician from Canada on 2012-08-27
Patient: female, weighing 56.6 kg (124.5 pounds)
Reactions: Diverticulitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ustekinumab
Indication: Psoriasis
Start date: 2012-03-26
Methotrexate
Indication: Product Used FOR Unknown Indication
Possible Methotrexate side effects in 10 year old male
Reported by a physician from United States on 2012-08-27
Patient: 10 year old male, weighing 76.1 kg (167.4 pounds)
Reactions: Hypersensitivity, Hyperglycaemia, Peripheral Motor Neuropathy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nelarabine
Dosage: 650mgm2 cyclic
Indication: T-Cell Type Acute Leukaemia
Start date: 2012-05-22
Cytarabine
Dosage: 75mgm2 cyclic
Indication: T-Cell Type Acute Leukaemia
Mercaptopurine
Dosage: 60mgm2 cyclic
Administration route: Oral
Indication: T-Cell Type Acute Leukaemia
PEG-Asparaginase
Indication: T-Cell Type Acute Leukaemia
Start date: 2012-06-13
Methotrexate
Indication: T-Cell Type Acute Leukaemia
Start date: 2012-06-06
Vincristine
Dosage: 1.5mgm2 cyclic
Indication: T-Cell Type Acute Leukaemia
Start date: 2012-06-13
Cyclophosphamide
Dosage: 1000mgm2 cyclic
Indication: T-Cell Type Acute Leukaemia
Other drugs received by patient: Radiation
Possible Methotrexate side effects in 59 year old
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 59 year old
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Methotrexate
Dosage: unk
Septra
Dosage: unk
Phenylephrine Hydrochloride
Dosage: unk
Chlorpheniramine Maleate
Dosage: unk
Albuterol Sulfate
Dosage: unk
Bactrim
Dosage: unk
Tetracycline Hydrochloride
Dosage: unk
Chlorpheniramine Maleate
Dosage: unk
Triprolidine Hydrochloride
Dosage: unk
Leflunomide
Dosage: unk
Ceclor
Dosage: unk
Amlodipine Besylate
Dosage: unk
Celebrex
Dosage: unk
Meclizine HCL
Dosage: unk
Phenylpropanolamine HCL
Dosage: unk
Naprosyn
Dosage: unk
Gemifloxacin Mesylate
Dosage: unk
Sulfanilamide
Dosage: unk
Astemizole
Dosage: unk
Lodine
Dosage: unk
Morphine Sulfate
Dosage: unk
Fosinopril Sodium
Dosage: unk
Fluticasone Propionate
Dosage: unk
Cefadroxil
Dosage: unk
Cefuroxime
Dosage: unk
Dexchlorpheniramine Maleate
Dosage: unk
Moxifloxacin Hydrochloride
Dosage: unk
Codeine Sulfate
Dosage: unk
Theophylline
Dosage: unk
Pseudoephedrine Hydrochloride
Dosage: unk
Pseudoephedrine Sulfate
Dosage: unk
Codeine Phosphate
Dosage: unk
Demerol
Dosage: unk
Acetaminophen
Dosage: unk
Oxymetazoline HCL
Dosage: unk
Methscopolamine Bromide
Dosage: unk
Phenyltoloxamine
Dosage: unk
Cromolyn Sodium
Dosage: unk
Caffeine Citrate
Dosage: unk
Aspirin
Dosage: unk
Possible Methotrexate side effects in 69 year old male
Reported by a physician from Switzerland on 2012-08-27
Patient: 69 year old male
Reactions: Mucosal Inflammation, Agranulocytosis, Glomerular Filtration Rate Decreased, Skin Lesion, Toxic Epidermal Necrolysis, Pancytopenia, Melaena, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mefenamic Acid
Dosage: as necessary
Administration route: Oral
Indication: Pain
Start date: 2012-07-05
End date: 2012-07-22
Methotrexate
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-18
Doxorubicin HCL
Dosage: total cumulates dose 880mg
Indication: Product Used FOR Unknown Indication
End date: 2012-07-05
Mefenamic Acid
Dosage: as necessary
Administration route: Oral
Indication: Pyrexia
Start date: 2012-07-05
End date: 2012-07-22
Targretin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Aspirin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-22
Novalgine
Dosage: as necessary
Administration route: Oral
Indication: Pain
Start date: 2012-07-05
End date: 2012-07-22
Methotrexate
Start date: 2012-07-11
Novalgine
Dosage: as necessary
Administration route: Oral
Indication: Pyrexia
Start date: 2012-07-05
End date: 2012-07-22
Other drugs received by patient: Hydrocortisone; Acetaminophen; Fenofibrate; Levothyroxine Sodium; Metformin HCL; Carvedilol
Possible Methotrexate side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 84.9 kg (186.8 pounds)
Reactions: Breast Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Methotrexate
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-06-15
End date: 2012-08-01
Avastin
Dosage: last dose prior to event - 27/jul/2012
Indication: Breast Cancer
Start date: 2012-06-15
Cyclophosphamide
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-06-15
End date: 2012-08-01
Possible Methotrexate side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male, weighing 26.7 kg (58.7 pounds)
Reactions: Crohn's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Crohn's Disease
Remicade
Start date: 2011-12-06
Methotrexate
Indication: Crohn's Disease
Start date: 2011-12-04
End date: 2012-01-20
Remicade
Other drugs received by patient: Multivitamin; Ferrous Sulfate TAB; Cholecalciferol; Cefdinir; Folic Acid; Oxycodone / Acetaminophen; Hydrocortisone; Metronidazole; Calcium Carbonate; Acetaminophen
Possible Methotrexate side effects in 54 year old female
Reported by a physician from Japan on 2012-08-27
Patient: 54 year old female
Reactions: Pneumocystis Jiroveci Pneumonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Rheumatoid Arthritis
Methotrexate
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Methotrexate side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: female, weighing 51.2 kg (112.6 pounds)
Reactions: Weight Decreased, Nasopharyngitis, Mouth Ulceration, Pain, Psoriasis, Pallor, Dysphonia, Fungal Infection, Asthenia
Drug(s) suspected as cause:
Remicade
Dosage: has had 20 inflixiamb infusions
Start date: 2012-08-16
Methotrexate
Remicade
Dosage: has had 20 inflixiamb infusions
Indication: Psoriatic Arthropathy
Start date: 2009-06-17
Methotrexate
Indication: Product Used FOR Unknown Indication
Start date: 2012-08-15
Other drugs received by patient: Folic Acid; Pantoprazole Sodium
Possible Methotrexate side effects in 39 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 39 year old female
Reactions: Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Injection Site Haematoma, Adverse Drug Reaction, False Positive Investigation Result, Joint Stiffness, Rheumatoid Arthritis, Malaise, Premature Rupture of Membranes, Umbilical Cord Around Neck, Amniotic Fluid Volume Decreased, Injection Site Induration, Breech Presentation, Drug Effect Decreased, Injection Site Pain, Hormone Level Abnormal, Lung Disorder, Arthralgia, Infertility
Drug(s) suspected as cause:
Methotrexate
Indication: Product Used FOR Unknown Indication
Humira
Start date: 2007-08-01
End date: 2008-12-01
Methotrexate
End date: 2012-08-10
Humira
Start date: 2009-08-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2006-01-01
End date: 2007-01-01
Other drugs received by patient: Methotrexate; Hormone Injections; Zyrtec; Prednisone TAB; BCP; Nasonex; Generic FOR Prilosec; Albuterol; Semar
Possible Methotrexate side effects in 45 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-27
Patient: 45 year old female
Reactions: Drug Ineffective, Systemic Lupus Erythematosus, Alopecia, Leukopenia
Drug(s) suspected as cause:
Methotrexate
Indication: Rheumatoid Arthritis
Infliximab, Recombinant
Dosage: 0 (initial dose of 3 mg/kg), 2, and 6 weeks and then every 8 weeks
Indication: Rheumatoid Arthritis
Possible Methotrexate side effects in 13 year old female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-27
Patient: 13 year old female
Reactions: Intra-Abdominal Haemorrhage, Pruritus, Febrile Neutropenia, Hyperaemia, Thoracic Haemorrhage, Mucosal Inflammation, Haemoglobin Decreased, Tumour Lysis Syndrome, Fungal Oesophagitis, Abdominal Distension, Pulmonary Oedema, Tachypnoea, Platelet Count Decreased, Renal Failure Acute, Blister
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Methotrexate
Other drugs received by patient: Etoposide; Cytarabine; Leucovorin Calcium
Possible Methotrexate side effects in
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-27
Patient:
Reactions: Acute Graft Versus Host Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Cyclosporine
Indication: Prophylaxis
Cyclosporine
Cyclosporine
Dosage: 1.5 mg/kg, every 12 hours
Indication: Stem Cell Transplant
Methotrexate
Dosage: 10 mg/m2, on day 3, 6 and 11 after transplant
Cyclosporine
Administration route: Oral
Methotrexate
Dosage: 15 mg/m2, 1 day
Indication: Prophylaxis Against Graft Versus Host Disease
Possible Methotrexate side effects in male
Reported by a physician from Canada on 2012-08-25
Patient: male
Reactions: Lung Adenocarcinoma Metastatic
Adverse event resulted in: death
Drug(s) suspected as cause:
Abatacept
Dosage: 125 milligram daily;
Start date: 2008-06-17
Methotrexate
Start date: 2010-12-01
End date: 2012-08-05
Other drugs received by patient: Amlodipine; Folic Acid; Metformin HCL; Telmisartan; Acetylsalicylic Acid SRT; Rosuvastatin; Prednisone TAB
Possible Methotrexate side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female, weighing 61.7 kg (135.8 pounds)
Reactions: Night Sweats, Malaise, Pyrexia, Chronic Myeloid Leukaemia
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Humira
Indication: Psoriatic Arthropathy
Start date: 2010-04-01
Methotrexate
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Prednisone TAB; Tasigna; Lyrica; Trazodone HCL; Prednisone TAB; Flonase; Premarin; Cymbalta; Flexeril; Ativan
Possible Methotrexate side effects in 71 year old female
Reported by a physician from Switzerland on 2012-08-24
Patient: 71 year old female
Reactions: Right Ventricular Failure, Aphthous Stomatitis, Bronchitis Chronic, Pulmonary Oedema, Arteriosclerosis Coronary Artery, Pneumonitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Methotrexate
Other drugs received by patient: Folic Acid; Prednisolone; Dexamethasone; Mefenamic Acid; Prednisolone; Diclofenac Sodium
Possible Methotrexate side effects in female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-24
Patient: female
Reactions: Escherichia Urinary Tract Infection, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Indication: Rheumatoid Arthritis
Start date: 2010-10-01
Methotrexate
Indication: Rheumatoid Arthritis
Other drugs received by patient: Amitriptyline HCL; Atacand; Dipyrone TAB; Torsemide
Possible Methotrexate side effects in 82 year old female
Reported by a consumer/non-health professional from Sweden on 2012-08-24
Patient: 82 year old female
Reactions: Large Intestinal Ulcer Haemorrhage, Diverticulitis
Drug(s) suspected as cause:
Orencia
Methotrexate
Possible Methotrexate side effects in 66 year old female
Reported by a physician from Czech Republic on 2012-08-24
Patient: 66 year old female, weighing 88.0 kg (193.6 pounds)
Reactions: Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2012-02-16
End date: 2012-02-23
Methotrexate
Start date: 2012-03-23
Humira
Indication: Rheumatoid Arthritis
Start date: 2012-02-15
Other drugs received by patient: Diclofenac Sodium; Aspirin; Atorvastatin; Gabapentin; Omeprazole; Perindopril Erbumine; Carvedilol; Metoprolol Tartrate; Lansoprazole; Folic Acid
Possible Methotrexate side effects in female
Reported by a physician from Japan on 2012-08-24
Patient: female, weighing 47.0 kg (103.4 pounds)
Reactions: Urinary Tract Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Golimumab
Start date: 2012-06-12
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2012-03-01
End date: 2012-03-01
Methotrexate
Administration route: Oral
Start date: 2012-04-11
End date: 2012-04-19
Methotrexate
Administration route: Oral
Start date: 2012-05-07
Methotrexate
Administration route: Oral
Start date: 2012-03-08
End date: 2012-03-08
Golimumab
Start date: 2012-04-17
Golimumab
Indication: Rheumatoid Arthritis
Start date: 2011-12-06
Methotrexate
Administration route: Oral
Start date: 2012-03-21
End date: 2012-03-21
Other drugs received by patient: Diclofenac Sodium; Aspara-CA; Edirol; Rebamipide; Sulfasalazine; Mizoribine; Prednisolone; Flurbiprofen; Cetraxate Hydrochloride; Alfacalcidol; Candesartan Cilexetil / Hydrochlorothiazide
Possible Methotrexate side effects in 51 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 51 year old female, weighing 53.0 kg (116.6 pounds)
Reactions: Vomiting, Pneumonia, Pain, Joint Dislocation, Urine Odour Abnormal, RIB Fracture, Thoracic Vertebral Fracture, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abatacept Subq Injection 125mg / ML
Dosage: next injection on 13aug2012
Indication: Rheumatoid Arthritis
Start date: 2011-12-01
Methotrexate
Prednisone TAB
Dosage: tapered down to 40 mg, 30 mg, 20 mg and to 10 mg. stayed on 10 mg for a couple of months and 5 mg
Possible Methotrexate side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female, weighing 91.6 kg (201.6 pounds)
Reactions: Vitamin D Deficiency, Blood Thyroid Stimulating Hormone, Breast Cancer, Bunion, Bladder Prolapse, Lymphadenopathy, Cystitis, Constipation, Therapeutic Response Decreased, Sialoadenitis, Hypertonic Bladder, Hypertension, Thyroid Neoplasm, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Start date: 2003-09-30
Methotrexate
Indication: Rheumatoid Arthritis
Start date: 1998-01-01
End date: 2005-01-01
Remicade
Indication: Rheumatoid Arthritis
Start date: 2011-01-01
Remicade
Start date: 2007-01-01
End date: 2011-01-01
Remicade
End date: 2007-01-01
Remicade
Dosage: approx. no. of infusion 53
Start date: 2012-05-16
Other drugs received by patient: Calcium; Ascorbic Acid; Docusate; Hydrochlorothiazide; Darvocet-N 50; Enalapril Maleate; Nexium; M.v.i.; Folic Acid; Tylenol; Vesicare; Meloxicam; Lorazepam; Meclizine; Mobic
Possible Methotrexate side effects in 43 year old female
Reported by a consumer/non-health professional from Argentina on 2012-08-23
Patient: 43 year old female
Reactions: Bronchopneumonia, Immune System Disorder, Application Site Pain, White Blood Cell Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Enbrel
Dosage: 50 mg, every 15 days
Indication: Rheumatoid Arthritis
Start date: 2007-03-03
End date: 2012-05-01
Methotrexate
Dosage: unk
Possible Methotrexate side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient: 53 year old male
Reactions: Weight Increased, Oedema Peripheral, Nephrotic Syndrome, Glomerulonephritis Membranous, Small Cell Lung Cancer Stage Unspecified
Drug(s) suspected as cause:
Prednisolone
Indication: Rheumatoid Arthritis
Methotrexate
Indication: Rheumatoid Arthritis
Tofacitinib Citrate
Indication: Rheumatoid Arthritis
Possible Methotrexate side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient: 54 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Chronic Myeloid Leukaemia
Drug(s) suspected as cause:
Enbrel
Dosage: daily dose: 50 mg millgram(s) every weeks
Indication: Polyarthritis
Start date: 2001-03-05
Methotrexate
Dosage: daily dose: 15 mg millgram(s) every weeks
Indication: Product Used FOR Unknown Indication
Start date: 1998-01-01
Other drugs received by patient: Diclofenac Sodium; Prednisone TAB
Possible Methotrexate side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 62 year old female
Reactions: Thyroid Cancer Recurrent
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Methotrexate
Start date: 2008-01-01
End date: 2008-03-01
Mabthera
Indication: Rheumatoid Arthritis
Start date: 2009-09-01
End date: 2010-03-01
Abatacept
Indication: Rheumatoid Arthritis
Start date: 2009-09-01
End date: 2010-03-01
Methotrexate
Indication: Rheumatoid Arthritis
Start date: 2008-04-01
End date: 2009-11-01
Tocilizumab
Indication: Rheumatoid Arthritis
Start date: 2010-04-01
End date: 2010-11-01
Golimumab
Indication: Rheumatoid Arthritis
Start date: 2010-11-01
End date: 2011-02-01
Other drugs received by patient: Leflunomide; Etanercept; Etanercept; Levothyroxine Sodium; Metformin
Possible Methotrexate side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient: 54 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Chronic Myeloid Leukaemia
Drug(s) suspected as cause:
Enbrel
Dosage: daily dose: 50 mg millgram(s) every weeks
Indication: Polyarthritis
Start date: 2001-03-05
Methotrexate
Dosage: daily dose: 15 mg millgram(s) every weeks
Indication: Product Used FOR Unknown Indication
Start date: 1998-01-01
Other drugs received by patient: Diclofenac Sodium; Prednisone TAB
Possible Methotrexate side effects in male
Reported by a physician from Netherlands on 2012-08-22
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Confusional State, Hepatic Enzyme Abnormal, Disorientation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Etoposide
Dosage: 212 mg, unk
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-07-28
Prednisolone
Dosage: 55 mg, bid
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-06-06
Cytarabine
Dosage: 360 mg, unk
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-07-28
Methotrexate
Dosage: 900 mg, unk
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-07-31
Methotrexate
Dosage: 15 mg, unk
Start date: 2012-08-06
Clofarabine
Dosage: 57 mg, qd
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-06-06
Other drugs received by patient: Esomeprazole Sodium; Oxazepam; Fluconazole
Possible Methotrexate side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male, weighing 78.0 kg (171.6 pounds)
Reactions: Pain in Extremity, Hypotension, Splenic Infarction, Paraesthesia, Septic Embolus, Fungal Test Positive, Hypoxia, Circulatory Collapse, Asthenia, Cough
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Methotrexate
Dosage: 30 m, intrathecal
End date: 2012-08-09
Prednisone
Dosage: 3360 mg, oral
Administration route: Oral
End date: 2012-08-08
PEG-L-Asparaginase (Pegaspargase, Oncospar)
Dosage: 4900 iu, intravenous
End date: 2012-07-15
Cytarabine
Dosage: 70 mg, intrathecal
End date: 2012-07-12
Daunorubicin HCL
Dosage: 200 mg
End date: 2012-08-02
Possible Methotrexate side effects in male
Reported by a physician from Germany on 2012-08-22
Patient: male
Reactions: Metastatic Bronchial Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Golimumab
Indication: Polyarthritis
Start date: 2011-03-01
End date: 2011-08-01
Sulfasalazine
Indication: Polyarthritis
Start date: 2009-07-01
End date: 2011-03-01
Abatacept
Indication: Polyarthritis
Start date: 2007-12-01
End date: 2008-06-01
Anakinra
Indication: Polyarthritis
Start date: 2008-08-01
End date: 2008-10-01
Roactemra
Indication: Polyarthritis
Start date: 2009-03-01
End date: 2009-06-01
Methotrexate
Indication: Polyarthritis
Start date: 2003-11-01
End date: 2008-09-01
Methotrexate
Start date: 2009-05-01
Certolizumab Pegol
Indication: Polyarthritis
Start date: 2011-09-01
End date: 2011-10-01
Adalimumab
Indication: Polyarthritis
Start date: 2006-08-01
End date: 2007-01-01
Possible Methotrexate side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-08-22
Patient: female
Reactions: Autoimmune Disorder, Skin Discolouration, Blood Thyroid Stimulating Hormone Increased, Injection Site Nodule
Drug(s) suspected as cause:
Rebif
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-01
Amlodipine
Indication: Autoimmune Disorder
Prednisone TAB
Indication: Autoimmune Disorder
Methotrexate
Indication: Autoimmune Disorder
Hydroxychloroquine Sulfate
Indication: Autoimmune Disorder
Spironolactone
Indication: Autoimmune Disorder
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