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
96244428 9624442 8 F 20130827 20160711 20131015 20160720 EXP US-TEVA-430490USA TEVA 73.39 YR M Y 98.10000 KG 20160720 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
96244428 9624442 1 PS Bendamustine BENDAMUSTINE 1 Intravenous (not otherwise specified) CYCLE 1 22249 216 MG
96244428 9624442 2 SS Bendamustine BENDAMUSTINE 1 22249 200 MG
96244428 9624442 3 SS RITUXIMAB RITUXIMAB 1 Intravenous (not otherwise specified) 900 MILLIGRAM DAILY; UID/QD 0 900 MG QD
96244428 9624442 4 SS RITUXIMAB RITUXIMAB 1 Intravenous (not otherwise specified) 800 MILLIGRAM DAILY; UID/QD 0 800 MG QD
96244428 9624442 5 SS Ibrutinib IBRUTINIB 1 Oral 560 MILLIGRAM DAILY; Y 0 560 MG QD
96244428 9624442 6 SS Ibrutinib IBRUTINIB 1 Oral 560 MILLIGRAM DAILY; Y 0 560 MG QD
96244428 9624442 7 SS Ibrutinib IBRUTINIB 1 Oral 560 MILLIGRAM DAILY; Y 0 560 MG QD
96244428 9624442 8 C FAMOTIDINE. FAMOTIDINE 1 Oral 40 MILLIGRAM DAILY; 0 20 MG BID
96244428 9624442 9 C FAMOTIDINE. FAMOTIDINE 1 0
96244428 9624442 10 C TAMSULOSIN TAMSULOSIN 1 Oral 0 .4 MG
96244428 9624442 11 C LISINOPRIL. LISINOPRIL 1 Oral 0 10 MG
96244428 9624442 12 C HEPARIN HEPARIN SODIUM 1 15000 IU (INTERNATIONAL UNIT) DAILY; 0 5000 IU Q8H
96244428 9624442 13 C HEPARIN HEPARIN SODIUM 1 15000 MILLIGRAM DAILY; 0 5000 MG Q8H
96244428 9624442 14 C HEPARIN HEPARIN SODIUM 1 22500 IU/KG DAILY; 0 7500 IU/KG Q8H
96244428 9624442 15 C COLACE DOCUSATE SODIUM 1 Oral 300 MILLIGRAM DAILY; 0 100 MG TID
96244428 9624442 16 C ENOXAPARIN ENOXAPARIN 1 40 MILLIGRAM DAILY; 0 40 MG QD
96244428 9624442 17 C PANTOPRAZOLE PANTOPRAZOLE SODIUM 1 40 MILLIGRAM DAILY; 0 40 MG QD
96244428 9624442 18 C PANTOPRAZOLE PANTOPRAZOLE SODIUM 1 40 MILLIGRAM DAILY; 0 40 MG QD
96244428 9624442 19 C SODIUM CHLORIDE. SODIUM CHLORIDE 1 SWISH AND SPIT 4 TIMES DAILY 0 QID
96244428 9624442 20 C SODIUM BICARBONATE. SODIUM BICARBONATE 1 SWISH AND SPIT 4 TIMES DAILY 0 QID
96244428 9624442 21 C ACETAMINOPHEN. ACETAMINOPHEN 1 Oral 2600 MILLIGRAM DAILY; 0 650 MG Q6H
96244428 9624442 22 C ACETAMINOPHEN. ACETAMINOPHEN 1 Oral 2600 MILLIGRAM DAILY; 0 650 MG Q6H
96244428 9624442 23 C ACETAMINOPHEN. ACETAMINOPHEN 1 Unknown 0
96244428 9624442 24 C DIPHENHYDRAMINE. DIPHENHYDRAMINE 1 Intravenous (not otherwise specified) 0 25 MG
96244428 9624442 25 C DIPHENHYDRAMINE. DIPHENHYDRAMINE 1 Intravenous (not otherwise specified) 25 MILLIGRAM DAILY; AS NEEDED 0 25 MG QD
96244428 9624442 26 C DIPHENHYDRAMINE. DIPHENHYDRAMINE 1 Intravenous (not otherwise specified) 100 MILLIGRAM DAILY; 0 25 MG Q6H
96244428 9624442 27 C DIPHENHYDRAMINE. DIPHENHYDRAMINE 1 Intravenous (not otherwise specified) 0
96244428 9624442 28 C DIPHENHYDRAMINE. DIPHENHYDRAMINE 1 0
96244428 9624442 29 C LORAZEPAM. LORAZEPAM 1 Intravenous (not otherwise specified) 0 1 MG
96244428 9624442 30 C LORAZEPAM. LORAZEPAM 1 0
96244428 9624442 31 C LORAZEPAM. LORAZEPAM 1 0
96244428 9624442 32 C OMEPRAZOL OMEPRAZOLE 1 Intravenous (not otherwise specified) 20 MILLIGRAM DAILY; 0 20 MG QD
96244428 9624442 33 C FUROSEMIDE. FUROSEMIDE 1 Oral 20 MILLIGRAM DAILY; 0 20 MG QD
96244428 9624442 34 C FUROSEMIDE. FUROSEMIDE 1 Oral 80 MILLIGRAM DAILY; 20 MG, IN 1 TOTAL 0 80 MG QD
96244428 9624442 35 C HYDREA HYDROXYUREA 1 Oral 12 GRAM DAILY; 0 3 G Q6H
96244428 9624442 36 C MAGNESIUM SULFATE. MAGNESIUM SULFATE 1 Intravenous (not otherwise specified) 4-10 GM, AS NEEDED 0
96244428 9624442 37 C PROMETHAZINE PROMETHAZINEPROMETHAZINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 25 MG, AS NEEDED (ONCE DAILY) 0 25 MG
96244428 9624442 38 C PROMETHAZINE PROMETHAZINEPROMETHAZINE HYDROCHLORIDE 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
96244428 9624442 1 Mantle cell lymphoma
96244428 9624442 3 Mantle cell lymphoma
96244428 9624442 5 Mantle cell lymphoma
96244428 9624442 8 Dyspepsia
96244428 9624442 10 Renal failure
96244428 9624442 11 Hypertension
96244428 9624442 12 Thrombosis prophylaxis
96244428 9624442 15 Constipation
96244428 9624442 16 Thrombosis prophylaxis
96244428 9624442 17 Dyspepsia
96244428 9624442 19 Prophylaxis
96244428 9624442 20 Prophylaxis
96244428 9624442 21 Osteoarthritis
96244428 9624442 22 Pyrexia
96244428 9624442 23 Pain
96244428 9624442 24 Pruritus
96244428 9624442 25 Nausea
96244428 9624442 26 Vomiting
96244428 9624442 27 Dystonia
96244428 9624442 28 Insomnia
96244428 9624442 29 Nausea
96244428 9624442 30 Vomiting
96244428 9624442 31 Anxiety
96244428 9624442 32 Gastrooesophageal reflux disease
96244428 9624442 33 Fluid retention
96244428 9624442 34 Oedema
96244428 9624442 35 White blood cell count increased
96244428 9624442 36 Electrolyte substitution therapy
96244428 9624442 37 Nausea
96244428 9624442 38 Vomiting

Outcome of event

Event ID CASEID OUTC COD
96244428 9624442 HO
96244428 9624442 LT
96244428 9624442 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
96244428 9624442 Acute kidney injury
96244428 9624442 Acute myocardial infarction
96244428 9624442 Ischaemic cardiomyopathy
96244428 9624442 Septic shock
96244428 9624442 Tumour lysis syndrome

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
96244428 9624442 1 20130827 20130828 0
96244428 9624442 2 20130924 20130925 0
96244428 9624442 3 20130827 20130828 0
96244428 9624442 4 20130924 0
96244428 9624442 5 20130827 20130828 0
96244428 9624442 6 20130920 20130923 0
96244428 9624442 7 20130924 20131007 0
96244428 9624442 8 20130814 0
96244428 9624442 9 20130828 0
96244428 9624442 10 20130816 0
96244428 9624442 12 20130828 0
96244428 9624442 13 20130906 0
96244428 9624442 14 20130912 0
96244428 9624442 15 20130817 0
96244428 9624442 16 20130814 0
96244428 9624442 17 20130814 0
96244428 9624442 18 20130830 0
96244428 9624442 19 20130415 0
96244428 9624442 20 20130815 0
96244428 9624442 21 20130814 0
96244428 9624442 22 20130828 0
96244428 9624442 24 20130814 0
96244428 9624442 25 20130828 0
96244428 9624442 26 20130814 0
96244428 9624442 29 20130814 0
96244428 9624442 32 20130822 0
96244428 9624442 33 20130817 0
96244428 9624442 34 20130828 0
96244428 9624442 35 20130814 0
96244428 9624442 36 20130814 0
96244428 9624442 37 20130828 0