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
109212584 10921258 4 F 20131009 20160805 20150317 20160809 EXP GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2013-BI-33193BI BOEHRINGER INGELHEIM 64.83 YR F Y 55.00000 KG 20160809 MD COUNTRY NOT SPECIFIED 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
109212584 10921258 1 PS BIBF 1120 NINTEDANIB 1 Oral 150 MG Y 205832 150 MG CAPSULE, SOFT QD
109212584 10921258 2 SS BIBF 1120 NINTEDANIB 1 Oral 300 MG Y 205832 150 MG CAPSULE, SOFT BID
109212584 10921258 3 SS BIBF 1120 NINTEDANIB 1 Oral 300 MG Y 205832 150 MG CAPSULE, SOFT BID
109212584 10921258 4 SS CISPLATIN. CISPLATIN 1 Intravenous (not otherwise specified) 48.2143 MG 0 112.5 MG TIW
109212584 10921258 5 SS CISPLATIN. CISPLATIN 1 0
109212584 10921258 6 SS PEMETREXED PEMETREXED 1 Intravenous (not otherwise specified) 240 MG 0 560 MG TIW
109212584 10921258 7 SS PEMETREXED PEMETREXED 1 Intravenous (not otherwise specified) 750 MG 0 750 MG QD
109212584 10921258 8 C ATORVASTATIN ATORVASTATIN 1 Oral 40 MG 0 40 MG QD
109212584 10921258 9 C ATORVASTATIN ATORVASTATIN 1 0
109212584 10921258 10 C LANSOPRAZOLE. LANSOPRAZOLE 1 Oral 40 MG 0 40 MG QD
109212584 10921258 11 C LANSOPRAZOLE. LANSOPRAZOLE 1 Unknown 30 MG 0 30 MG QD
109212584 10921258 12 C RAMIPRIL. RAMIPRIL 1 Unknown 5 MG 0 5 MG QD
109212584 10921258 13 C RAMIPRIL. RAMIPRIL 1 Oral 10 MG 0 10 MG QD
109212584 10921258 14 C DIAZEPAM. DIAZEPAM 1 Oral 2 MG 0 2 MG QD
109212584 10921258 15 C PARACETAMOL ACETAMINOPHEN 1 Oral 0
109212584 10921258 16 C METOCLOPROMIDE METOCLOPRAMIDE 1 Oral 30 MG 0 30 MG QD
109212584 10921258 17 C METOCLOPROMIDE METOCLOPRAMIDE 1 0
109212584 10921258 18 C FOLIC ACID. FOLIC ACID 1 Oral 400 MCG 0 400 UG QD
109212584 10921258 19 C FOLIC ACID. FOLIC ACID 1 Unknown 0
109212584 10921258 20 C VITAMIN B12 CYANOCOBALAMIN 1 Unknown 0
109212584 10921258 21 C APREPITANT. APREPITANT 1 Unknown 125 MG 0 125 MG QD
109212584 10921258 22 C APREPITANT. APREPITANT 1 0
109212584 10921258 23 C ONDANSETRON ONDANSETRON 1 Oral 8 MG 0 8 MG QD
109212584 10921258 24 C ONDANSETRON ONDANSETRON 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
109212584 10921258 1 Pleural mesothelioma malignant
109212584 10921258 4 Pleural mesothelioma malignant
109212584 10921258 5 Lung neoplasm malignant
109212584 10921258 6 Pleural mesothelioma malignant
109212584 10921258 7 Lung neoplasm malignant
109212584 10921258 8 Hypertension
109212584 10921258 9 Hypercholesterolaemia
109212584 10921258 10 Gastrooesophageal reflux disease
109212584 10921258 12 Hypertension
109212584 10921258 14 Anxiety
109212584 10921258 15 Pain
109212584 10921258 16 Nausea
109212584 10921258 17 Prophylaxis of nausea and vomiting
109212584 10921258 18 Premedication
109212584 10921258 20 Premedication
109212584 10921258 21 Premedication
109212584 10921258 22 Prophylaxis of nausea and vomiting
109212584 10921258 23 Premedication
109212584 10921258 24 Prophylaxis of nausea and vomiting

Outcome of event

Event ID CASEID OUTC COD
109212584 10921258 HO
109212584 10921258 OT
109212584 10921258 LT

Reactions reported

Event ID CASEID DRUG REC ACT PT
109212584 10921258 Alanine aminotransferase increased
109212584 10921258 Blood alkaline phosphatase increased
109212584 10921258 Blood creatinine increased
109212584 10921258 Constipation
109212584 10921258 Dizziness
109212584 10921258 Fatigue
109212584 10921258 Feeling of body temperature change
109212584 10921258 Gamma-glutamyltransferase increased
109212584 10921258 Hypokalaemia
109212584 10921258 Nausea
109212584 10921258 Urinary retention

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
109212584 10921258 1 20131009 20131015 0
109212584 10921258 2 20131029 0
109212584 10921258 3 20131106 0
109212584 10921258 4 20131008 0
109212584 10921258 6 20131008 0
109212584 10921258 8 2007 0
109212584 10921258 10 1998 0
109212584 10921258 11 1998 0
109212584 10921258 12 2007 0
109212584 10921258 13 20131107 0
109212584 10921258 14 20131002 0
109212584 10921258 16 20131008 0
109212584 10921258 18 20131002 0
109212584 10921258 19 20131002 0
109212584 10921258 20 20131002 0
109212584 10921258 21 20131008 0
109212584 10921258 23 20131008 0