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
123786253 12378625 3 F 20160426 20160622 20160517 20160705 EXP AR-TAKEDA-2016MPI004330 TAKEDA 73.86 YR F Y 67.00000 KG 20160705 MD AR AR

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
123786253 12378625 1 PS VELCADE BORTEZOMIB 1 Subcutaneous 1.7 MG, UNK Y 4370492 21602 1.7 MG INJECTION
123786253 12378625 2 SS VELCADE BORTEZOMIB 1 Subcutaneous 2.3 MG, UNK Y 4370492 21602 2.3 MG INJECTION
123786253 12378625 3 SS VELCADE BORTEZOMIB 1 Subcutaneous 1.7 MG, UNK Y 4370492 21602 1.7 MG INJECTION
123786253 12378625 4 SS VELCADE BORTEZOMIB 1 Subcutaneous UNK Y 4370492 21602 INJECTION
123786253 12378625 5 SS VELCADE BORTEZOMIB 1 Subcutaneous 1.7 MG, UNK Y 4370492 21602 1.7 MG INJECTION
123786253 12378625 6 SS PREDNISONE. PREDNISONE 1 Oral 2.3 MG, UNK 4371073;4371050 0 2.3 MG
123786253 12378625 7 SS DARATUMUMAB DARATUMUMAB 1 Intravenous (not otherwise specified) 1072 MG, UNK 4370945 0 1072 MG
123786253 12378625 8 SS MELPHALAN MELPHALAN 1 Oral 16 MG, UNK 4371043 0 16 MG
123786253 12378625 9 C TRAMADOL. TRAMADOL 1 Oral UNK, TID 0 TABLET TID
123786253 12378625 10 C ACICLOVIR ACYCLOVIR 1 Oral 500 MG, UNK 0 500 MG TABLET
123786253 12378625 11 C MORFINE MORPHINE 1 Oral UNK 0 ORAL LIQUID
123786253 12378625 12 C MORFINE MORPHINE 1 Oral UNK 0 ORAL LIQUID
123786253 12378625 13 C MORPHINE /00036302/ MORPHINE 1 Intravenous (not otherwise specified) 20 MG, UNK 0 20 MG INJECTION
123786253 12378625 14 C DEXAMETHASONE. DEXAMETHASONE 1 Intravenous (not otherwise specified) 40 MG, UNK 0 40 MG INJECTION
123786253 12378625 15 C FLUCONAZOLE. FLUCONAZOLE 1 Oral 200 MG, UNK 0 200 MG TABLET
123786253 12378625 16 C ENOXAPARIN ENOXAPARIN 1 Subcutaneous 40 MG, UNK 0 40 MG INJECTION
123786253 12378625 17 C ENOXAPARIN ENOXAPARIN 1 Subcutaneous 40 MG, UNK 0 40 MG INJECTION
123786253 12378625 18 C AGAROL LAXATIVE 2 Oral 10 ML, UNK 0 10 ML ORAL LIQUID
123786253 12378625 19 C OMEPRAZOLE. OMEPRAZOLE 1 Oral 20 MG, BID 0 20 MG TABLET BID
123786253 12378625 20 C PARACETAMOL ACETAMINOPHEN 1 Oral UNK, TID 0 TABLET TID
123786253 12378625 21 C METOCLOPRAMIDE. METOCLOPRAMIDE 1 Oral UNK 0 ORAL LIQUID
123786253 12378625 22 C RIVOTRIL CLONAZEPAM 1 Oral 2 MG, UNK 0 2 MG TABLET
123786253 12378625 23 C ENALAPRIL ENALAPRIL 1 Oral 10 MG, BID 0 10 MG TABLET BID
123786253 12378625 24 C AMLODIPINE AMLODIPINE BESYLATE 1 Oral 10 MG, UNK 0 10 MG TABLET
123786253 12378625 25 C MANITOL 2 Oral 10 MG, UNK 0 10 MG TABLET
123786253 12378625 26 C BISACODILO 2 Oral UNK 0 TABLET
123786253 12378625 27 C PAMIDRONATE PAMIDRONATE DISODIUM 1 Oral 100 MG, UNK 0 100 MG TABLET
123786253 12378625 28 C LACTULON /00160501/ 2 Oral 10 ML, UNK 0 10 ML
123786253 12378625 29 C CALCIUM CALCIUM 1 Oral UNK 0 TABLET
123786253 12378625 30 C CEFTRIAXONE. CEFTRIAXONE 1 Intravenous (not otherwise specified) 2 G, UNK 0 2 G INJECTION
123786253 12378625 31 C NEUPOGEN FILGRASTIM 1 Intravenous (not otherwise specified) 300 ?G, UNK 0 300 UG INJECTION
123786253 12378625 32 C NEUPOGEN FILGRASTIM 1 Intravenous (not otherwise specified) 300 ?G, UNK 0 300 UG INJECTION
123786253 12378625 33 C ZOMETA ZOLEDRONIC ACID 1 Intravenous (not otherwise specified) 4 MG, UNK 0 4 MG INJECTION
123786253 12378625 34 C FUROSEMIDE. FUROSEMIDE 1 Intravenous (not otherwise specified) 20 MG, UNK 0 20 MG INJECTION
123786253 12378625 35 C DILTIAZEM. DILTIAZEM 1 Oral UNK, BID 0 TABLET BID
123786253 12378625 36 C PIPERACILLIN/TAZOBACTAM PIPERACILLIN SODIUMTAZOBACTAM SODIUM 1 Intravenous (not otherwise specified) 4.5 G, TID 81 G 0 4.5 G INJECTION TID

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
123786253 12378625 1 Plasma cell myeloma
123786253 12378625 6 Plasma cell myeloma
123786253 12378625 7 Plasma cell myeloma
123786253 12378625 8 Plasma cell myeloma
123786253 12378625 9 Pain
123786253 12378625 10 Antiviral prophylaxis
123786253 12378625 11 Back pain
123786253 12378625 13 Back pain
123786253 12378625 14 Back pain
123786253 12378625 15 Antifungal prophylaxis
123786253 12378625 16 Thrombosis prophylaxis
123786253 12378625 18 Constipation
123786253 12378625 19 Gastrointestinal disorder therapy
123786253 12378625 20 Pain
123786253 12378625 21 Prophylaxis of nausea and vomiting
123786253 12378625 22 Insomnia
123786253 12378625 23 Hypertension
123786253 12378625 24 Hypertension
123786253 12378625 25 Constipation
123786253 12378625 26 Constipation
123786253 12378625 27 Plasma cell myeloma
123786253 12378625 28 Constipation
123786253 12378625 29 Plasma cell myeloma
123786253 12378625 30 Infection
123786253 12378625 31 Prophylaxis
123786253 12378625 33 Plasma cell myeloma
123786253 12378625 34 Fluid overload
123786253 12378625 35 Hypertension
123786253 12378625 36 Infection

Outcome of event

Event ID CASEID OUTC COD
123786253 12378625 HO
123786253 12378625 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
123786253 12378625 Blood alkaline phosphatase increased
123786253 12378625 Fluid overload
123786253 12378625 Infection
123786253 12378625 Neutropenia

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
123786253 12378625 1 20160513 0
123786253 12378625 2 20160422 20160425 0
123786253 12378625 3 20160520 0
123786253 12378625 5 20160516 0
123786253 12378625 6 20160423 20160425 0
123786253 12378625 7 20160422 20160422 0
123786253 12378625 8 20160422 20160425 0
123786253 12378625 9 20160322 0
123786253 12378625 10 20160421 0
123786253 12378625 11 20160414 20160415 0
123786253 12378625 12 20160416 20160419 0
123786253 12378625 13 20160412 20160413 0
123786253 12378625 14 20160412 20160414 0
123786253 12378625 15 20160412 20160420 0
123786253 12378625 16 20160412 20160416 0
123786253 12378625 17 20160428 20160503 0
123786253 12378625 18 2005 0
123786253 12378625 19 20160322 0
123786253 12378625 20 20160401 0
123786253 12378625 21 20160401 0
123786253 12378625 22 2000 0
123786253 12378625 23 20160413 0
123786253 12378625 24 20160322 0
123786253 12378625 25 20160414 20160415 0
123786253 12378625 26 20160415 0
123786253 12378625 27 20160328 0
123786253 12378625 28 20160422 0
123786253 12378625 29 20160422 0
123786253 12378625 30 20160426 20160426 0
123786253 12378625 31 20160427 20160427 0
123786253 12378625 32 20160501 20160501 0
123786253 12378625 33 20160504 0
123786253 12378625 34 20160501 20160501 0
123786253 12378625 36 20160426 20160504 0