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
125809052 12580905 2 F 20160202 20160824 20160721 20160826 EXP GB-CONCORDIA PHARMACEUTICALS INC.-GSH201607-003681 CONCORDIA 72.00 YR F Y 69.00000 KG 20160826 OT 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
125809052 12580905 1 PS PREDNISOLONE. PREDNISOLONE 1 Oral DOSAGE FORM: UNSPECIFIED, DAY 1 TO DAY 4 U 21959
125809052 12580905 2 SS MELPHALAN MELPHALAN 1 Oral DOSAGE FORM: UNSPECIFIED, DAY 1 TO DAY 4 U 0
125809052 12580905 3 SS VELCADE BORTEZOMIB 1 Subcutaneous DOSAGE FORM: LYOPHILIZED POWDER, ON DAYS 1, 4, 8, 11, 22, 29 U 0 2.15 MG
125809052 12580905 4 C ACICLOVIR ACYCLOVIR 1 Oral 0 400 MG TABLET
125809052 12580905 5 C ACICLOVIR ACYCLOVIR 1 Oral 0 500 MG TABLET
125809052 12580905 6 C ACICLOVIR ACYCLOVIR 1 Oral 0 300 MG TABLET
125809052 12580905 7 C ALENDRONIC ACID ALENDRONIC ACID 1 Oral 0 70 MG TABLET
125809052 12580905 8 C ALLOPURINOL. ALLOPURINOL 1 Oral 0 300 MG TABLET
125809052 12580905 9 C ALLOPURINOL. ALLOPURINOL 1 Oral 0 100 MG TABLET
125809052 12580905 10 C CHLORPHENAMINE CHLORPHENIRAMINE MALEATE 1 Oral 0 4 MG TABLET
125809052 12580905 11 C CHLORPHENAMINE CHLORPHENIRAMINE MALEATE 1 Oral 0 4 MG TABLET
125809052 12580905 12 C CITALOPRAM CITALOPRAM HYDROBROMIDE 1 Oral 0 20 MG TABLET
125809052 12580905 13 C DALTEPARIN DALTEPARIN 1 Subcutaneous DOSAGE FORM: SOLUTION 0 5000 IU TABLET
125809052 12580905 14 C DALTEPARIN DALTEPARIN 1 Subcutaneous DOSAGE FORM: SOLUTION 0 TABLET
125809052 12580905 15 C DALTEPARIN DALTEPARIN 1 Subcutaneous DOSAGE FORM: SOLUTION 0 2500 IU TABLET
125809052 12580905 16 C G-CSF GRANULOCYTE COLONY-STIMULATING FACTOR NOS 1 Subcutaneous DOSAGE FORM: SOLUTION 0
125809052 12580905 17 C GLUCOSE DEXTROSE 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 0 1000 ML
125809052 12580905 18 C LITHIUM CARBONATE. LITHIUM CARBONATE 1 Oral 0 200 MG TABLET
125809052 12580905 19 C LORAZEPAM. LORAZEPAM 1 Oral 0 1 MG TABLET
125809052 12580905 20 C MEROPENEM. MEROPENEM 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 33 G 0 1 G
125809052 12580905 21 C MEROPENEM. MEROPENEM 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 33 G 0 1 G BID
125809052 12580905 22 C MEROPENEM. MEROPENEM 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 33 G 0 1 G TID
125809052 12580905 23 C ONDANSETRON ONDANSETRON 1 Oral 0 8 MG TABLET
125809052 12580905 24 C PARACETAMOL ACETAMINOPHEN 1 Oral 0 1 G TABLET
125809052 12580905 25 C PHOSPHATE SANDOZ EFFERVESCENT 2 Oral 0 TABLET BID
125809052 12580905 26 C PHOSPHATE SANDOZ EFFERVESCENT 2 Oral 0 TABLET
125809052 12580905 27 C SALBUTAMOL ALBUTEROL 1 Respiratory (inhalation) DOSAGE FORM: POWDER 0 2.5 MG
125809052 12580905 28 C SEPTRIN SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 0 TABLET
125809052 12580905 29 C SODIUM CHLORIDE. SODIUM CHLORIDE 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 0 1000 ML
125809052 12580905 30 C TAZOCIN PIPERACILLIN SODIUMTAZOBACTAM SODIUM 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 90 G 0 4.5 G
125809052 12580905 31 C TAZOCIN PIPERACILLIN SODIUMTAZOBACTAM SODIUM 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 90 G 0 4.5 G BID
125809052 12580905 32 C VANCOMYCIN VANCOMYCIN 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 15000 MG 0 500 MG BID
125809052 12580905 33 C VANCOMYCIN VANCOMYCIN 1 Intravenous (not otherwise specified) DOSAGE FORM: SOLUTION 15000 MG 0 500 MG
125809052 12580905 34 C ZANAMIVIR ZANAMIVIR 1 Respiratory (inhalation) DOSAGE FORM: POWDER 0 5 MG

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125809052 12580905 1 Plasma cell myeloma
125809052 12580905 2 Plasma cell myeloma
125809052 12580905 3 Plasma cell myeloma
125809052 12580905 4 Viral infection
125809052 12580905 5 Viral infection
125809052 12580905 6 Viral infection
125809052 12580905 7 Osteoporosis
125809052 12580905 8 Tumour lysis syndrome
125809052 12580905 9 Tumour lysis syndrome
125809052 12580905 10 Rash macular
125809052 12580905 11 Rash
125809052 12580905 12 Bipolar disorder
125809052 12580905 13 Thrombosis
125809052 12580905 14 Thrombosis
125809052 12580905 15 Thrombosis
125809052 12580905 16 Neutropenia
125809052 12580905 17 Sepsis
125809052 12580905 18 Bipolar disorder
125809052 12580905 19 Bipolar disorder
125809052 12580905 20 Sepsis
125809052 12580905 21 Sepsis
125809052 12580905 22 Sepsis
125809052 12580905 23 Nausea
125809052 12580905 24 Sepsis
125809052 12580905 25 Sepsis
125809052 12580905 26 Sepsis
125809052 12580905 27 Dyspnoea
125809052 12580905 28 Sepsis
125809052 12580905 29 Sepsis
125809052 12580905 30 Sepsis
125809052 12580905 31 Sepsis
125809052 12580905 32 Sepsis
125809052 12580905 33 Sepsis
125809052 12580905 34 Dyspnoea

Outcome of event

Event ID CASEID OUTC COD
125809052 12580905 OT
125809052 12580905 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
125809052 12580905 Confusional state
125809052 12580905 Dehydration
125809052 12580905 Dyspnoea
125809052 12580905 Nausea
125809052 12580905 Neutropenia
125809052 12580905 Rash
125809052 12580905 Rash macular
125809052 12580905 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
125809052 12580905 1 20160202 20160205 0
125809052 12580905 2 20160202 20160205 0
125809052 12580905 3 20160202 20160209 0
125809052 12580905 4 20160222 0
125809052 12580905 5 20160215 20160216 0
125809052 12580905 6 20160219 20160219 0
125809052 12580905 7 1995 20160213 0
125809052 12580905 8 20160216 20160222 0
125809052 12580905 9 20160223 0
125809052 12580905 10 20160212 20160212 0
125809052 12580905 11 20160212 20160212 0
125809052 12580905 12 1995 0
125809052 12580905 13 20160221 20160221 0
125809052 12580905 14 20160212 20160214 0
125809052 12580905 15 20160222 20160224 0
125809052 12580905 16 20160217 20160218 0
125809052 12580905 17 20160213 20160213 0
125809052 12580905 18 1995 0
125809052 12580905 19 20160225 20160225 0
125809052 12580905 20 20160212 20160212 0
125809052 12580905 21 20160217 20160217 0
125809052 12580905 22 20160213 20160216 0
125809052 12580905 23 20160218 20160218 0
125809052 12580905 24 20160211 0
125809052 12580905 25 20160215 20160215 0
125809052 12580905 26 20160216 20160216 0
125809052 12580905 27 20160218 20160218 0
125809052 12580905 28 20160216 0
125809052 12580905 29 20160211 20160222 0
125809052 12580905 30 20160211 20160211 0
125809052 12580905 31 20160212 20160212 0
125809052 12580905 32 20160217 20160217 0
125809052 12580905 33 20160216 20160216 0
125809052 12580905 34 20160216 0