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
1185397513 11853975 13 F 20150906 20160906 20151219 20160917 EXP JP-AMGEN-JPNCT2015136483 AMGEN 76.00 YR E M Y 52.50000 KG 20160917 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
1185397513 11853975 1 PS panitumumab PANITUMUMAB 1 Intravenous drip 6 MG/KG, Q2WEEKS 36 MG/KG Y Y 125147 6 MG/KG SOLUTION FOR INJECTION QOW
1185397513 11853975 2 SS panitumumab PANITUMUMAB 1 Intravenous drip 6 MG/KG, Q2WEEKS 36 MG/KG Y Y 125147 6 MG/KG SOLUTION FOR INJECTION QOW
1185397513 11853975 3 SS panitumumab PANITUMUMAB 1 Intravenous drip 6 MG/KG, Q2WEEKS 36 MG/KG Y Y 125147 6 MG/KG SOLUTION FOR INJECTION QOW
1185397513 11853975 4 SS panitumumab PANITUMUMAB 1 Intravenous drip 6 MG/KG, Q2WEEKS 36 MG/KG Y Y 125147 6 MG/KG SOLUTION FOR INJECTION QOW
1185397513 11853975 5 SS panitumumab PANITUMUMAB 1 Intravenous drip 6 MG/KG, Q2WEEKS 36 MG/KG Y Y 125147 6 MG/KG SOLUTION FOR INJECTION QOW
1185397513 11853975 6 SS panitumumab PANITUMUMAB 1 Intravenous drip 4.8 MG/KG, Q2WEEKS 36 MG/KG Y Y 125147 4.8 MG/KG SOLUTION FOR INJECTION QOW
1185397513 11853975 7 SS panitumumab PANITUMUMAB 1 Intravenous drip 3.6 MG/KG, Q2WK 36 MG/KG Y Y 125147 3.6 MG/KG SOLUTION FOR INJECTION QOW
1185397513 11853975 8 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous bolus 400 MG/M2, Q2WEEKS 14800 MG/M2 U 0 400 MG/M**2 QOW
1185397513 11853975 9 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous drip 2400 MG/M2, Q2WEEKS 14800 MG/M2 U 0 2400 MG/M**2 QOW
1185397513 11853975 10 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous bolus 400 MG/M2, Q2WEEKS 14800 MG/M2 U 0 400 MG/M**2 QOW
1185397513 11853975 11 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous drip 2400 MG/M2, Q2WEEKS 14800 MG/M2 U 0 2400 MG/M**2 QOW
1185397513 11853975 12 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous bolus 400 MG/M2, Q2WEEKS 14800 MG/M2 U 0 400 MG/M**2 QOW
1185397513 11853975 13 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous drip 2400 MG/M2, Q2WK 14800 MG/M2 U 0 2400 MG/M**2 QOW
1185397513 11853975 14 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous bolus 200 MG/M2, Q2WEEKS 14800 MG/M2 U 0 200 MG/M**2 QOW
1185397513 11853975 15 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous drip 2000 MG/M2, Q2WEEKS 14800 MG/M2 U 0 2000 MG/M**2 QOW
1185397513 11853975 16 SS 5-FU /00098801/ FLUOROURACIL 1 Intravenous drip 1600 MG/M2, Q2WEEKS 14800 MG/M2 U 0 1600 MG/M**2 QOW
1185397513 11853975 17 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous drip 85 MG/M2, Q2WEEKS 510 MG/M2 U 0 85 MG/M**2 QOW
1185397513 11853975 18 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous drip 85 MG/M2, Q2WEEKS 510 MG/M2 U 0 85 MG/M**2 QOW
1185397513 11853975 19 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous drip 85 MG/M2, Q2WEEKS 510 MG/M2 U 0 85 MG/M**2 QOW
1185397513 11853975 20 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous drip 65 MG/M2, Q2WEEKS 510 MG/M2 U 0 65 MG/M**2 QOW
1185397513 11853975 21 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous drip 50 MG/M2, Q2WEEKS 510 MG/M2 U 0 50 MG/M**2 QOW
1185397513 11853975 22 C CALCIUM LEVOFOLINATE LEVOLEUCOVORIN CALCIUM 1 Intravenous drip 200 MG/M2, Q2WEEKS 1200 MG/M2 U 0 200 MG/M**2 QOW
1185397513 11853975 23 C CALCIUM LEVOFOLINATE LEVOLEUCOVORIN CALCIUM 1 Intravenous drip 200 MG/M2, Q2WEEKS 1200 MG/M2 U 0 200 MG/M**2 QOW
1185397513 11853975 24 C CALCIUM LEVOFOLINATE LEVOLEUCOVORIN CALCIUM 1 Intravenous drip 200 MG/M2, Q2WEEKS 1200 MG/M2 U 0 200 MG/M**2 QOW
1185397513 11853975 25 C CALCIUM LEVOFOLINATE LEVOLEUCOVORIN CALCIUM 1 Intravenous drip 200 MG/M2, Q2WEEKS 1200 MG/M2 U 0 200 MG/M**2 QOW
1185397513 11853975 26 C CALCIUM LEVOFOLINATE LEVOLEUCOVORIN CALCIUM 1 Intravenous drip 200 MG/M2, Q2WEEKS 1200 MG/M2 U 0 200 MG/M**2 QOW
1185397513 11853975 27 C SPIRONOLACTONE. SPIRONOLACTONE 1 Oral 25 MG, QD U 0 25 MG QD
1185397513 11853975 28 C MAGNESIUM OXIDE. MAGNESIUM OXIDE 1 Oral 0.67 G, TID U 0 .67 G TID
1185397513 11853975 29 C RABEPRAZOLE NA RABEPRAZOLE SODIUM 1 Oral 10 MG, QD U 0 10 MG QD
1185397513 11853975 30 C LIXIANA EDOXABAN TOSILATE MONOHYDRATE 1 Oral 30 MG, QD U 0 30 MG QD
1185397513 11853975 31 C FERRUM /00023505/ 2 Oral 100 MG, QD U 0 100 MG QD
1185397513 11853975 32 C OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral 15 MG, BID U 0 15 MG BID
1185397513 11853975 33 C OXINORM /00045603/ OXYCODONE HYDROCHLORIDE 1 Oral 2.5 MG, UNK U 0 2.5 MG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
1185397513 11853975 1 Rectosigmoid cancer
1185397513 11853975 8 Rectosigmoid cancer
1185397513 11853975 17 Rectosigmoid cancer
1185397513 11853975 22 Rectosigmoid cancer
1185397513 11853975 27 Prophylaxis
1185397513 11853975 28 Prophylaxis
1185397513 11853975 29 Prophylaxis
1185397513 11853975 30 Prophylaxis
1185397513 11853975 31 Prophylaxis
1185397513 11853975 32 Pain management
1185397513 11853975 33 Pain management

Outcome of event

Event ID CASEID OUTC COD
1185397513 11853975 HO
1185397513 11853975 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
1185397513 11853975 Decreased appetite
1185397513 11853975 Enterocolitis haemorrhagic
1185397513 11853975 Epistaxis
1185397513 11853975 Febrile neutropenia
1185397513 11853975 Haematuria
1185397513 11853975 Hypomagnesaemia
1185397513 11853975 Nausea
1185397513 11853975 Neutrophil count decreased Neutrophil count decreased
1185397513 11853975 Paronychia
1185397513 11853975 Peripheral sensory neuropathy
1185397513 11853975 Platelet count decreased
1185397513 11853975 White blood cell count decreased

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
1185397513 11853975 1 20150904 20150904 0
1185397513 11853975 2 20150925 20151023 0
1185397513 11853975 3 20151113 20151127 0
1185397513 11853975 4 20151218 20160108 0
1185397513 11853975 5 20160205 20160219 0
1185397513 11853975 6 20160318 20160401 0
1185397513 11853975 7 20160506 0
1185397513 11853975 8 20150904 20150904 0
1185397513 11853975 9 20150904 20150904 0
1185397513 11853975 10 20150925 20151023 0
1185397513 11853975 11 20150925 20151023 0
1185397513 11853975 12 20151113 20151127 0
1185397513 11853975 13 20151113 20151127 0
1185397513 11853975 14 20151218 20160108 0
1185397513 11853975 15 20151218 20160108 0
1185397513 11853975 16 20160205 0
1185397513 11853975 17 20150904 20150904 0
1185397513 11853975 18 20150925 20151023 0
1185397513 11853975 19 20151113 20151127 0
1185397513 11853975 20 20151218 20160108 0
1185397513 11853975 21 20160205 20160318 0
1185397513 11853975 22 20150904 20150904 0
1185397513 11853975 23 20150925 20151023 0
1185397513 11853975 24 20151113 20151127 0
1185397513 11853975 25 20151218 20160108 0
1185397513 11853975 26 20160205 0
1185397513 11853975 27 20151114 0
1185397513 11853975 28 20150821 0
1185397513 11853975 29 20150929 0
1185397513 11853975 30 201508 0
1185397513 11853975 31 20150919 0
1185397513 11853975 32 20150904 0
1185397513 11853975 33 20150904 0

Execution Time: 0.021866083145142 seconds (ucode:5193737). Developed by: James D. Barger

 


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