The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
116865146 11686514 6 F 20151004 20160825 20151030 20160829 EXP JP-AMGEN-JPNSP2015114415 AMGEN KAWAHARA Y. A CASE OF INTERSTITIAL PNEUMONIA WHICH DEVELOPED IN AN UNCOMMON CLINICAL COURSE DURING FEC THERAPY IN COMBINATION WITH PEGFILGRASTIM AFTER SURGERY FOR BREAST CANCER.. THE 24TH ANNUAL MEETING OF THE JAPANESE BREAST. 2016;534 51.00 YR A F Y 43.00000 KG 20160828 MD JP JP

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
116865146 11686514 1 PS G-LASTA PEGFILGRASTIM 1 Subcutaneous 3.6 MG, QD 12 MG U 125031 3.6 MG SOLUTION FOR INJECTION QD
116865146 11686514 2 SS G-LASTA PEGFILGRASTIM 1 Subcutaneous 3.6 MG, QD 12 MG U 125031 3.6 MG SOLUTION FOR INJECTION QD
116865146 11686514 3 SS G-LASTA PEGFILGRASTIM 1 Subcutaneous 3.6 MG, QD 12 MG U 125031 3.6 MG SOLUTION FOR INJECTION QD
116865146 11686514 4 SS G-LASTA PEGFILGRASTIM 1 Subcutaneous UNK 12 MG U 125031 SOLUTION FOR INJECTION
116865146 11686514 5 SS G-LASTA PEGFILGRASTIM 1 Subcutaneous UNK 12 MG U 125031 SOLUTION FOR INJECTION
116865146 11686514 6 SS G-LASTA PEGFILGRASTIM 1 Subcutaneous UNK 12 MG U 125031 SOLUTION FOR INJECTION
116865146 11686514 7 SS 5-FU FLUOROURACIL 1 Intravenous drip 675 MG, 1X/3WEEKS 0 675 MG INJECTION
116865146 11686514 8 SS 5-FU FLUOROURACIL 1 Intravenous (not otherwise specified) UNK 0 INJECTION
116865146 11686514 9 SS 5-FU FLUOROURACIL 1 Intravenous drip UNK 0 INJECTION
116865146 11686514 10 SS EPIRUBICIN HYDROCHLORIDE. EPIRUBICIN HYDROCHLORIDE 1 Intravenous drip 135 MG, 1X/3WEEKS 270 MG 0 135 MG INJECTION Q3W
116865146 11686514 11 SS EPIRUBICIN HYDROCHLORIDE. EPIRUBICIN HYDROCHLORIDE 1 Intravenous drip UNK 270 MG 0 INJECTION
116865146 11686514 12 SS EPIRUBICIN HYDROCHLORIDE. EPIRUBICIN HYDROCHLORIDE 1 Intravenous drip UNK 270 MG 0 INJECTION
116865146 11686514 13 SS EPIRUBICIN HYDROCHLORIDE. EPIRUBICIN HYDROCHLORIDE 1 Intravenous drip UNK 270 MG 0 INJECTION
116865146 11686514 14 SS CYCLOPHOSPHAMIDE MONOHYDRATE CYCLOPHOSPHAMIDE 1 Intravenous drip UNK 0
116865146 11686514 15 SS CYCLOPHOSPHAMIDE MONOHYDRATE CYCLOPHOSPHAMIDE 1 Intravenous drip UNK 0
116865146 11686514 16 SS CYCLOPHOSPHAMIDE MONOHYDRATE CYCLOPHOSPHAMIDE 1 Intravenous drip UNK 0
116865146 11686514 17 SS ENDOXAN CYCLOPHOSPHAMIDE 1 Intravenous drip 675 MG, 1X/3WEEKS 1350 MG 0 675 MG INJECTION Q3W
116865146 11686514 18 SS KAMISHOYOSAN /07987101/ HERBALS 1 Oral 2 G, TID 576 G 0 2 G TID
116865146 11686514 19 C ORGADRONE DEXAMETHASONE SODIUM PHOSPHATE 1 Unknown 7.6 MG, QD 0 7.6 MG INJECTION QD
116865146 11686514 20 C DECADRON DEXAMETHASONE 1 Oral 2 MG, DAY 2-4 0 2 MG TABLET BID
116865146 11686514 21 C ZANTAC RANITIDINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 50 MG, QD 0 50 MG INJECTION QD
116865146 11686514 22 C ALOXI PALONOSETRON HYDROCHLORIDE 1 Intravenous (not otherwise specified) 0.75 MG, 1X/3WEEKS 1.5 MG 0 .75 MG INJECTION Q3W
116865146 11686514 23 C EMEND APREPITANT 1 Oral 120 MG, QD 0 120 MG CAPSULE QD
116865146 11686514 24 C EMEND APREPITANT 1 Oral 80 MG, QD (DAY 2-3) 0 80 MG CAPSULE QD
116865146 11686514 25 C MUCOSTA REBAMIPIDE 1 Oral 100 MG, TID (DAY 2-6) 0 100 MG TABLET TID
116865146 11686514 26 C CEFAZOLIN SODIUM. CEFAZOLIN SODIUM 1 Intravenous (not otherwise specified) 1 G, TID 6 G 0 1 G INJECTION TID
116865146 11686514 27 C LOBU LOBUCAVIR 1 Oral 60 MG, TID 3060 MG 0 60 MG TABLET TID
116865146 11686514 28 C ALDIOXA ALDIOXA 1 Oral 100 MG, TID 5100 MG 0 100 MG TABLET TID
116865146 11686514 29 C LEVOFLOXACIN HEMIHYDRATE LEVOFLOXACIN 1 Oral 500 MG, QD 0 500 MG TABLET QD
116865146 11686514 30 C AUGMENTIN AMOXICILLINCLAVULANATE POTASSIUM 1 Oral 250 MG, TID 2250 MG 0 250 MG TABLET TID
116865146 11686514 31 C AUGMENTIN AMOXICILLINCLAVULANATE POTASSIUM 1 Oral 250 MG, TID 2250 MG 0 250 MG TABLET TID
116865146 11686514 32 C PASETOCIN AMOXICILLIN 1 Oral 250 MG, TID 0 250 MG TID
116865146 11686514 33 C ANYRUME ACETAMINOPHEN 1 Oral 400 MG, PRN 0 400 MG TABLET
116865146 11686514 34 C CEFEPIME HYDROCHLORIDE. CEFEPIME HYDROCHLORIDE 1 Intravenous (not otherwise specified) 2 G, TID 0 2 G TID
116865146 11686514 35 C MEROPENEM. MEROPENEM 1 Intravenous (not otherwise specified) 1 G, TID 0 1 G INJECTION TID
116865146 11686514 36 C VANCOMYCIN VANCOMYCIN 1 Intravenous (not otherwise specified) 1 G, QD 0 1 G INJECTION QD
116865146 11686514 37 C FUNGUARD MICAFUNGIN SODIUM 1 Intravenous (not otherwise specified) 100 MG, QD 0 100 MG INJECTION QD
116865146 11686514 38 C MIYA-BM CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 1 Oral 40 MG, TID 0 40 MG TABLET TID
116865146 11686514 39 C FLAGYL METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE 1 Oral 500 MG, BID 0 500 MG TABLET BID

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
116865146 11686514 1 Product used for unknown indication
116865146 11686514 7 Breast cancer
116865146 11686514 10 Breast cancer
116865146 11686514 14 Breast cancer stage II
116865146 11686514 17 Breast cancer
116865146 11686514 18 Menopausal symptoms
116865146 11686514 26 Infection prophylaxis
116865146 11686514 27 Procedural pain
116865146 11686514 28 Gastritis prophylaxis
116865146 11686514 29 Antibiotic therapy
116865146 11686514 30 Antibiotic therapy
116865146 11686514 32 Antibiotic therapy
116865146 11686514 33 Antipyresis
116865146 11686514 34 Antibiotic therapy
116865146 11686514 35 Antibiotic therapy
116865146 11686514 36 Antibiotic therapy
116865146 11686514 37 Antibiotic therapy
116865146 11686514 38 Enterocolitis
116865146 11686514 39 Enterocolitis

Outcome of event

Event ID CASEID OUTC COD
116865146 11686514 OT
116865146 11686514 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
116865146 11686514 Interstitial lung disease
116865146 11686514 Neutropenia
116865146 11686514 Neutrophil count decreased
116865146 11686514 Pyrexia

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
116865146 11686514 1 20150820 20150820 0
116865146 11686514 2 20150911 20150911 0
116865146 11686514 3 20151002 20151002 0
116865146 11686514 7 20150818 20150930 0
116865146 11686514 10 20150818 20150930 0
116865146 11686514 17 20150818 20150930 0
116865146 11686514 18 20150701 20151016 0
116865146 11686514 22 20150818 20150930 0
116865146 11686514 26 20150714 20150715 0
116865146 11686514 27 20150715 20150731 0
116865146 11686514 28 20150715 20150731 0
116865146 11686514 30 20150922 20150924 0
116865146 11686514 31 20151005 20151007 0
116865146 11686514 34 20151009 20151010 0
116865146 11686514 35 20151010 20151016 0
116865146 11686514 36 20151013 20151016 0
116865146 11686514 37 20151013 20151017 0
116865146 11686514 38 20151013 20151028 0
116865146 11686514 39 20151013 20151028 0

Execution Time: 0.0079588890075684 seconds (ucode:5097599). Developed by: James D. Barger

 


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