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
119882932 11988293 2 F 20150730 20160728 20160202 20160808 EXP US-TAKEDA-2016MPI000516 TAKEDA 73.90 YR F Y 105.20000 KG 20160808 MD US US

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
119882932 11988293 1 PS VELCADE BORTEZOMIB 1 Subcutaneous 2.8 MG, UNK 21602 2.8 MG INJECTION
119882932 11988293 2 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.1 MG, UNK 21602 2.1 MG INJECTION
119882932 11988293 3 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.15 MG, UNK 21602 2.15 MG INJECTION
119882932 11988293 4 SS VELCADE BORTEZOMIB 1 Subcutaneous 1.5 MG, UNK 21602 1.5 MG INJECTION
119882932 11988293 5 SS PREDNISONE. PREDNISONE 1 Oral 120 MG, QD 480 MG 0 120 MG TABLET QD
119882932 11988293 6 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 480 MG 0 100 MG TABLET
119882932 11988293 7 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 480 MG 0 100 MG TABLET
119882932 11988293 8 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 480 MG 0 100 MG TABLET
119882932 11988293 9 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 480 MG 0 100 MG TABLET
119882932 11988293 10 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 480 MG 0 100 MG TABLET
119882932 11988293 11 SS PREDNISONE. PREDNISONE 1 Oral 100 MG, UNK 480 MG 0 100 MG TABLET
119882932 11988293 12 SS MELPHALAN MELPHALAN 1 Oral 20 MG, QD 80 MG Y 0 20 MG QD
119882932 11988293 13 SS MELPHALAN MELPHALAN 1 Oral 14 MG, UNK 80 MG Y 0 14 MG
119882932 11988293 14 SS MELPHALAN MELPHALAN 1 Oral 10 MG, UNK 80 MG Y 0 10 MG
119882932 11988293 15 SS MELPHALAN MELPHALAN 1 Oral 10 MG, UNK 80 MG Y 0 10 MG
119882932 11988293 16 SS MELPHALAN MELPHALAN 1 Oral 10 MG, UNK 80 MG Y 0 10 MG
119882932 11988293 17 SS MELPHALAN MELPHALAN 1 Oral 10 MG, UNK 80 MG Y 0 10 MG
119882932 11988293 18 SS MELPHALAN MELPHALAN 1 Oral 10 MG, UNK 80 MG Y 0 10 MG
119882932 11988293 19 C VANCOMYCIN VANCOMYCIN 1 Oral 125 MG, QID 7500 MG 0 125 MG QID
119882932 11988293 20 C VANCOMYCIN VANCOMYCIN 1 Oral 125 MG, QID 7500 MG 0 125 MG QID
119882932 11988293 21 C VANCOMYCIN VANCOMYCIN 1 Oral 250 MG, QID 7500 MG 0 250 MG QID
119882932 11988293 22 C ALLOPURINOL. ALLOPURINOL 1 Oral 300 MG, BID 0 300 MG TABLET BID
119882932 11988293 23 C ALLOPURINOL. ALLOPURINOL 1 Oral 200 MG, QD 0 200 MG TABLET QD
119882932 11988293 24 C NEURONTIN GABAPENTIN 1 Oral 300 MG, BID 0 300 MG TABLET BID
119882932 11988293 25 C ZYRTEC CETIRIZINE HYDROCHLORIDE 1 Oral 10 MG, UNK 0 10 MG TABLET
119882932 11988293 26 C WARFARIN WARFARIN 1 Oral 2.5 MG, 3/WEEK 0 2.5 MG TABLET TIW
119882932 11988293 27 C WARFARIN WARFARIN 1 Oral 5 MG, UNK 0 5 MG TABLET
119882932 11988293 28 C FELODIPINE. FELODIPINE 1 Unknown 5 MG, QD 0 5 MG QD
119882932 11988293 29 C METOPROLOL. METOPROLOL 1 Oral 150 MG, BID 0 150 MG CAPSULE BID
119882932 11988293 30 C ATORVASTATIN ATORVASTATIN 1 Oral 80 MG, QD 0 80 MG TABLET QD
119882932 11988293 31 C NORMAL SALINE SODIUM CHLORIDE 1 Intravenous (not otherwise specified) 500 IU, UNK 0 500 IU ORAL LIQUID
119882932 11988293 32 C POTASSIUM CHLORIDE. POTASSIUM CHLORIDE 1 Oral UNK, QD 0 CAPSULE QD
119882932 11988293 33 C POTASSIUM CHLORIDE. POTASSIUM CHLORIDE 1 Oral 40 MG, QD 0 40 MG CAPSULE QD
119882932 11988293 34 C ONDANSETRON ONDANSETRON 1 Oral 8 MG, UNK 0 8 MG CAPSULE
119882932 11988293 35 C ONDANSETRON ONDANSETRON 1 Oral 8 UNK, UNK 0 8 MG CAPSULE
119882932 11988293 36 C ONDANSETRON ONDANSETRON 1 Oral 4 MG, UNK 0 4 MG CAPSULE
119882932 11988293 37 C FILGRASTIM FILGRASTIM 1 Subcutaneous 480 ?G, QD 0 480 UG ORAL LIQUID QD
119882932 11988293 38 C CHLORMADINONE CHLORMADINONE 1 Unknown UNK 0
119882932 11988293 39 C ENOXAPARIN ENOXAPARIN 1 Subcutaneous 110 MG, BID 0 110 MG ORAL LIQUID BID
119882932 11988293 40 C ENOXAPARIN ENOXAPARIN 1 Subcutaneous 60 MG, BID 0 60 MG ORAL LIQUID BID
119882932 11988293 41 C ACYCLOVIR /00587301/ ACYCLOVIR 1 Oral 400 MG, BID 0 400 MG CAPSULE BID
119882932 11988293 42 C DOXYCYCLINE. DOXYCYCLINE 1 Oral 100 MG, BID 0 100 MG CAPSULE BID
119882932 11988293 43 C SODIUM CHLORIDE. SODIUM CHLORIDE 1 Intravenous (not otherwise specified) 500 ML, UNK 0 500 ML ORAL LIQUID
119882932 11988293 44 C SODIUM CHLORIDE. SODIUM CHLORIDE 1 Intravenous (not otherwise specified) 250 ML, UNK 0 250 ML ORAL LIQUID
119882932 11988293 45 C FLAGYL METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE 1 Oral 500 MG, TID 0 500 MG CAPSULE TID
119882932 11988293 46 C ACETAMINOPHEN. ACETAMINOPHEN 1 Oral 650 MG, UNK 0 650 MG CAPSULE
119882932 11988293 47 C PANTOPRAZOLE PANTOPRAZOLE SODIUM 1 Oral 40 MG, QD 0 40 MG CAPSULE QD
119882932 11988293 48 C FLUTICASONE FLUTICASONEFLUTICASONE PROPIONATE 1 Respiratory (inhalation) UNK, QD 0 QD
119882932 11988293 49 C FLUTICASONE FLUTICASONEFLUTICASONE PROPIONATE 1 0
119882932 11988293 50 C INSULIN INSULIN NOS 1 Subcutaneous UNK 0 ORAL LIQUID
119882932 11988293 51 C MONTELUKAST ALTER 2 Oral 10 MG, QD 0 10 MG CAPSULE QD
119882932 11988293 52 C GABAPENTIN. GABAPENTIN 1 Oral 300 MG, BID 0 300 MG CAPSULE BID
119882932 11988293 53 C LORATADINE. LORATADINE 1 Oral 10 MG, QD 0 10 MG CAPSULE QD
119882932 11988293 54 C AZTREONAM. AZTREONAM 1 Intravenous (not otherwise specified) 1 G, BID 0 1 G ORAL LIQUID BID
119882932 11988293 55 C MAGNESIUM SULFATE. MAGNESIUM SULFATE 1 Intravenous (not otherwise specified) 4 G, UNK 0 4 G
119882932 11988293 56 C MAGNESIUM SULFATE. MAGNESIUM SULFATE 1 Oral 2 MG, UNK 0 2 MG
119882932 11988293 57 C MAGNESIUM SULFATE. MAGNESIUM SULFATE 1 Oral 4 MG, UNK 0 4 MG
119882932 11988293 58 C PROCHLORPERAZINE. PROCHLORPERAZINE 1 Intravenous (not otherwise specified) 10 MG, UNK 0 10 MG ORAL LIQUID
119882932 11988293 59 C FUROSEMIDE. FUROSEMIDE 1 Oral 40 MG, UNK 0 40 MG TABLET
119882932 11988293 60 C BACITRACIN. BACITRACIN 1 Topical UNK, QD 0 OINTMENT QD
119882932 11988293 61 C METFORMIN METFORMIN HYDROCHLORIDE 1 Oral 500 MG, BID 0 500 MG TABLET BID
119882932 11988293 62 C METOLAZONE. METOLAZONE 1 Oral 2.5 MG, QD 0 2.5 MG TABLET QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
119882932 11988293 1 Plasma cell myeloma
119882932 11988293 5 Plasma cell myeloma
119882932 11988293 12 Plasma cell myeloma
119882932 11988293 19 Infection
119882932 11988293 20 Clostridium difficile infection
119882932 11988293 22 Prophylaxis
119882932 11988293 25 Rhinorrhoea
119882932 11988293 26 Cardiac valve prosthesis user
119882932 11988293 27 Thrombosis prophylaxis
119882932 11988293 28 Hypertension
119882932 11988293 29 Hypertension
119882932 11988293 30 Hyperlipidaemia
119882932 11988293 31 Clostridium difficile infection
119882932 11988293 32 Hypokalaemia
119882932 11988293 34 Prophylaxis of nausea and vomiting
119882932 11988293 35 Nausea
119882932 11988293 37 White blood cell count decreased
119882932 11988293 38 Weight decreased
119882932 11988293 39 Deep vein thrombosis
119882932 11988293 41 Antiviral prophylaxis
119882932 11988293 42 Clostridium difficile infection
119882932 11988293 43 Supportive care
119882932 11988293 45 Clostridium difficile infection
119882932 11988293 46 Premedication
119882932 11988293 47 Gastrooesophageal reflux disease
119882932 11988293 48 Prophylaxis
119882932 11988293 49 Nasal dryness
119882932 11988293 50 Type 2 diabetes mellitus
119882932 11988293 51 Allergy prophylaxis
119882932 11988293 52 Peripheral sensory neuropathy
119882932 11988293 53 Allergy prophylaxis
119882932 11988293 54 Febrile neutropenia
119882932 11988293 55 Hypomagnesaemia
119882932 11988293 58 Prophylaxis of nausea and vomiting
119882932 11988293 59 Fluid overload
119882932 11988293 60 Infection prophylaxis
119882932 11988293 61 Type 2 diabetes mellitus
119882932 11988293 62 Fluid overload

Outcome of event

Event ID CASEID OUTC COD
119882932 11988293 HO
119882932 11988293 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
119882932 11988293 Anaemia
119882932 11988293 Cardiac failure
119882932 11988293 Clostridium difficile infection
119882932 11988293 Decreased appetite
119882932 11988293 Dizziness
119882932 11988293 Fatigue
119882932 11988293 Febrile neutropenia
119882932 11988293 Hypoalbuminaemia
119882932 11988293 Hypokalaemia
119882932 11988293 Hypomagnesaemia
119882932 11988293 Nausea
119882932 11988293 Peripheral sensory neuropathy
119882932 11988293 Rectal haemorrhage
119882932 11988293 Thrombocytopenia
119882932 11988293 Weight decreased
119882932 11988293 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
119882932 11988293 1 20150730 20150831 0
119882932 11988293 2 20150910 20151008 0
119882932 11988293 3 20151022 20151119 0
119882932 11988293 4 20160503 20160602 0
119882932 11988293 5 20150730 20150802 0
119882932 11988293 6 20150910 20150913 0
119882932 11988293 7 20151022 20151025 0
119882932 11988293 8 20151207 201512 0
119882932 11988293 9 20160116 20160119 0
119882932 11988293 10 20160307 201603 0
119882932 11988293 11 20160507 201605 0
119882932 11988293 12 20150730 20150802 0
119882932 11988293 13 20150910 20150913 0
119882932 11988293 14 20151022 20151025 0
119882932 11988293 15 20151203 20151206 0
119882932 11988293 16 20160114 20160117 0
119882932 11988293 17 20160303 20160306 0
119882932 11988293 18 20160503 20160606 0
119882932 11988293 19 20150711 20150725 0
119882932 11988293 20 20150807 20150814 0
119882932 11988293 21 20150814 20150911 0
119882932 11988293 23 20150730 0
119882932 11988293 26 2011 20150808 0
119882932 11988293 27 20150808 20150810 0
119882932 11988293 28 20110101 0
119882932 11988293 29 2011 0
119882932 11988293 30 2005 0
119882932 11988293 31 20150807 0
119882932 11988293 32 20150807 20150809 0
119882932 11988293 33 20150822 20150826 0
119882932 11988293 34 20150708 20150812 0
119882932 11988293 35 20150812 0
119882932 11988293 36 20150813 0
119882932 11988293 37 20150814 20150816 0
119882932 11988293 39 20150825 0
119882932 11988293 40 20150810 20150826 0
119882932 11988293 41 20150811 20150827 0
119882932 11988293 42 20150811 20150821 0
119882932 11988293 43 20150807 20150807 0
119882932 11988293 44 20150811 20150811 0
119882932 11988293 45 20150813 20150827 0
119882932 11988293 46 20150809 0
119882932 11988293 47 20110101 0
119882932 11988293 48 20050101 0
119882932 11988293 50 20150811 20150829 0
119882932 11988293 51 20150807 0
119882932 11988293 52 20140201 0
119882932 11988293 53 20150807 0
119882932 11988293 54 20150823 20150825 0
119882932 11988293 55 20150826 0
119882932 11988293 56 20150808 20150808 0
119882932 11988293 57 20150809 20150809 0
119882932 11988293 58 20150826 0
119882932 11988293 59 20150901 0
119882932 11988293 60 20150902 0
119882932 11988293 61 1999 0
119882932 11988293 62 20150909 20150911 0