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
121749978 12174997 8 F 20160203 20160914 20160314 20160923 EXP GB-JNJFOC-20160206998 JANSSEN 68.02 YR E F Y 93.00000 KG 20160923 MD GB GB

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
121749978 12174997 1 PS DARATUMUMAB DARATUMUMAB 1 Intravenous (not otherwise specified) Y N 067349;067350;067351 761036 CONCENTRATE FOR SOLUTION FOR INFUSION
121749978 12174997 2 SS DARATUMUMAB DARATUMUMAB 1 Intravenous (not otherwise specified) CYCLE (C) 1 DAY (D) 1, 8, 15, 22, 29, 36, C2D1, D22, C3D1. FREQUENCY: AS PER PROTOCOL Y N 067349;067350;067351 100638 1420 MG CONCENTRATE FOR SOLUTION FOR INFUSION
121749978 12174997 3 SS VELCADE BORTEZOMIB 1 Subcutaneous CYCLE 3 DAY 1 Y V14464-03 0 2 MG LYOPHILIZED POWDER
121749978 12174997 4 SS VELCADE BORTEZOMIB 1 Subcutaneous CYCLE 2 DAY 22, 29 Y V14464-03 0 2.6 MG LYOPHILIZED POWDER
121749978 12174997 5 SS VELCADE BORTEZOMIB 1 Subcutaneous CYCLE (C) 1 DAY (D) 1, 4, 8, 11, 22, 25, 29 Y V14464-03 0 2.6 MG LYOPHILIZED POWDER
121749978 12174997 6 SS VELCADE BORTEZOMIB 1 Subcutaneous CYCLE 2 DAY 8 Y V14464-03 0 2.7 MG LYOPHILIZED POWDER
121749978 12174997 7 SS MELPHALAN MELPHALAN 1 Oral Y 0 12 MG
121749978 12174997 8 SS MELPHALAN MELPHALAN 1 Oral Y 0 18 MG
121749978 12174997 9 SS PREDNISOLONE. PREDNISOLONE 1 Oral Y 0 125 MG
121749978 12174997 10 SS PREDNISOLONE. PREDNISOLONE 1 Oral Y 0 120 MG
121749978 12174997 11 SS PREDNISOLONE. PREDNISOLONE 1 Oral Y 0 120 MG
121749978 12174997 12 C HYDROXOCOBALAMIN HYDROXOCOBALAMIN 1 Intramuscular D 0 1 MG
121749978 12174997 13 C HYDROXOCOBALAMIN HYDROXOCOBALAMIN 1 Intramuscular D 0 1 MG
121749978 12174997 14 C ADCAL D3 CALCIUM CARBONATECHOLECALCIFEROL 1 Oral D 0 TABLET
121749978 12174997 15 C FUROSEMIDE. FUROSEMIDE 1 Oral D 0 40 MG TABLET BID
121749978 12174997 16 C FUROSEMIDE. FUROSEMIDE 1 Oral D 0 40 MG TABLET QD
121749978 12174997 17 C FOLIC ACID. FOLIC ACID 1 Oral D 0 5 MG UNSPECIFIED QD
121749978 12174997 18 C VITAMIN B COMPLEX CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX 1 Oral D 0 TABLET
121749978 12174997 19 C MAGNESIUM GLYCEROPHOSPHATE MAGNESIUM GLYCEROPHOSPHATE 1 Oral D 0 10 ML LIQUID BID
121749978 12174997 20 C OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral D 0 5 MG LIQUID BID
121749978 12174997 21 C OXYCONTIN OXYCODONE HYDROCHLORIDE 1 Oral D 0 5 MG LIQUID BID
121749978 12174997 22 C OXYNORM OXYCODONE HYDROCHLORIDE 1 Oral D 0 5 MG TABLET
121749978 12174997 23 C OXYNORM OXYCODONE HYDROCHLORIDE 1 Oral D 0 5 MG TABLET
121749978 12174997 24 C ZOMETA ZOLEDRONIC ACID 1 Intravenous (not otherwise specified) D 0 4 MG LIQUID /month
121749978 12174997 25 C LOSARTAN. LOSARTAN 1 Oral D 0 100 MG TABLET QD
121749978 12174997 26 C METFORMIN METFORMIN HYDROCHLORIDE 1 Oral D 0 500 MG TABLET BID
121749978 12174997 27 C OMEPRAZOLE. OMEPRAZOLE 1 Oral D 0 20 MG TABLET QD
121749978 12174997 28 C BISOPROLOL BISOPROLOL 1 D 0 1.25 MG
121749978 12174997 29 C DOXYCYCLINE. DOXYCYCLINE 1 Oral D 0 100 MG TABLET
121749978 12174997 30 C LEVOTHYROXINE SODIUM. LEVOTHYROXINE SODIUM 1 Oral D 0 50 UG TABLET
121749978 12174997 31 C LEVOTHYROXINE SODIUM. LEVOTHYROXINE SODIUM 1 Oral D 0 25 UG TABLET
121749978 12174997 32 C CIPROFLOXACIN. CIPROFLOXACIN 1 Oral D 0 500 MG TABLET BID
121749978 12174997 33 C CO-DYDRAMOL ACETAMINOPHENDIHYDROCODEINE 1 Oral D 0 TABLET
121749978 12174997 34 C PARACETAMOL ACETAMINOPHEN 1 Oral D 0 1 G TABLET QID
121749978 12174997 35 C ALLOPURINOL. ALLOPURINOL 1 Oral D 0 300 MG TABLET
121749978 12174997 36 C SENNA SENNA LEAFSENNOSIDESSENNOSIDES A AND B 1 Oral D 0 TABLET
121749978 12174997 37 C PREDNISOLONE. PREDNISOLONE 1 Oral D 0 5 MG TABLET
121749978 12174997 38 C PREDNISOLONE. PREDNISOLONE 1 Oral D 0 20 MG TABLET
121749978 12174997 39 C PREDNISOLONE. PREDNISOLONE 1 Oral D 0 20 MG TABLET
121749978 12174997 40 C PREDNISOLONE. PREDNISOLONE 1 Oral D 0 5 MG TABLET
121749978 12174997 41 C FLUCONAZOLE. FLUCONAZOLE 1 Oral D 0 1 G TABLET QID
121749978 12174997 42 C BISOPROLOL BISOPROLOL 1 Oral D 0 25 MG TAPE

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
121749978 12174997 2 Plasma cell myeloma
121749978 12174997 3 Plasma cell myeloma
121749978 12174997 4 Plasma cell myeloma
121749978 12174997 5 Plasma cell myeloma
121749978 12174997 6 Plasma cell myeloma
121749978 12174997 7 Plasma cell myeloma
121749978 12174997 8 Plasma cell myeloma
121749978 12174997 9 Plasma cell myeloma
121749978 12174997 10 Plasma cell myeloma
121749978 12174997 11 Plasma cell myeloma
121749978 12174997 12 Neuropathy peripheral
121749978 12174997 13 Macrocytosis
121749978 12174997 14 Hypocalcaemia
121749978 12174997 15 Peripheral swelling
121749978 12174997 16 Peripheral swelling
121749978 12174997 17 Macrocytosis
121749978 12174997 18 Neuropathy peripheral
121749978 12174997 19 Blood magnesium decreased
121749978 12174997 20 Neuropathy peripheral
121749978 12174997 21 Neuralgia
121749978 12174997 22 Neuropathy peripheral
121749978 12174997 23 Neuralgia
121749978 12174997 24 Plasma cell myeloma
121749978 12174997 25 Hypertension
121749978 12174997 26 Type 2 diabetes mellitus
121749978 12174997 27 Gastrooesophageal reflux disease
121749978 12174997 28 Hypertension
121749978 12174997 29 Upper respiratory tract infection
121749978 12174997 30 Hypothyroidism
121749978 12174997 31 Hypothyroidism
121749978 12174997 32 Infection prophylaxis
121749978 12174997 33 Back pain
121749978 12174997 34 Back pain
121749978 12174997 35 Prophylaxis
121749978 12174997 36 Constipation
121749978 12174997 37 Plasma cell myeloma
121749978 12174997 38 Plasma cell myeloma
121749978 12174997 39 Upper respiratory tract infection
121749978 12174997 40 Upper respiratory tract infection
121749978 12174997 41 Back pain
121749978 12174997 42 Hypertension

Outcome of event

Event ID CASEID OUTC COD
121749978 12174997 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
121749978 12174997 Atrial fibrillation
121749978 12174997 Sepsis

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
121749978 12174997 2 20151102 0
121749978 12174997 3 20160201 0
121749978 12174997 4 20160111 20160118 0
121749978 12174997 5 20151102 20151222 0
121749978 12174997 6 20151229 0
121749978 12174997 7 20151221 20151224 0
121749978 12174997 8 20151102 20151105 0
121749978 12174997 9 20151102 20151105 0
121749978 12174997 10 20151222 20151224 0
121749978 12174997 11 20160202 20160204 0
121749978 12174997 12 20160129 20160201 0
121749978 12174997 13 20160129 20160201 0
121749978 12174997 14 20160129 0
121749978 12174997 15 20160129 20160229 0
121749978 12174997 16 20160112 20160129 0
121749978 12174997 17 20160129 0
121749978 12174997 18 20160129 0
121749978 12174997 19 20160129 0
121749978 12174997 20 20160129 0
121749978 12174997 21 20160129 0
121749978 12174997 22 20160129 0
121749978 12174997 23 20160129 0
121749978 12174997 24 20160131 0
121749978 12174997 25 2010 0
121749978 12174997 26 2011 20160212 0
121749978 12174997 27 2011 0
121749978 12174997 28 2009 0
121749978 12174997 29 2011 0
121749978 12174997 30 1995 0
121749978 12174997 31 1995 0
121749978 12174997 32 20151113 0
121749978 12174997 33 20151114 0
121749978 12174997 34 20151204 0
121749978 12174997 35 20151205 0
121749978 12174997 36 20151204 0
121749978 12174997 37 2011 0
121749978 12174997 38 20151102 0
121749978 12174997 39 20151102 0
121749978 12174997 40 2011 0
121749978 12174997 41 20151204 0
121749978 12174997 42 2009 20160205 0

Execution Time: 0.011761903762817 seconds (ucode:5045938). Developed by: James D. Barger

 


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