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
111447146 11144714 6 F 20141030 20160915 20150528 20160921 EXP JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-53656NB BOEHRINGER INGELHEIM 55.29 YR F Y 49.20000 KG 20160921 MD JP JP

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
111447146 11144714 1 PS GILOTRIF AFATINIB 1 Oral 30 MG Y 201292 30 MG FILM COATED TABLET QD
111447146 11144714 2 SS GILOTRIF AFATINIB 1 Oral 20 MG Y 201292 20 MG FILM COATED TABLET QD
111447146 11144714 3 SS GILOTRIF AFATINIB 1 Oral 10 MG Y 201292 20 MG FILM COATED TABLET QOD
111447146 11144714 4 SS FENTOS FENTANYL 1 Unknown 1 MG Y 0 1 MG TRANSDERMAL PATCH QD
111447146 11144714 5 SS MORPHINE MORPHINE 1 Unknown Y 0
111447146 11144714 6 C AVASTIN BEVACIZUMAB 1 Unknown 0.7143 CLI-33 0 15 MG/KG INJECTION Q3W
111447146 11144714 7 C PROMAC NITROFURANTOIN 1 Oral 1 G 0 1 G GRANULES QD
111447146 11144714 8 C AMITIZA LUBIPROSTONE 1 Oral 48 MCG 0 48 UG CAPSULE QD
111447146 11144714 9 C LUPRAC TORSEMIDE 1 Oral 8 MG 0 8 MG TABLET QD
111447146 11144714 10 C ALDACTONE A SPIRONOLACTONE 1 Oral 25 MG 0 25 MG TABLET QD
111447146 11144714 11 C PARIET RABEPRAZOLE SODIUM 1 Oral 20 MG 0 20 MG TABLET QD
111447146 11144714 12 C LYRICA PREGABALIN 1 Oral 150 MG 0 150 MG CAPSULE QD
111447146 11144714 13 C MOBIC MELOXICAM 1 Oral 10 MG 0 10 MG TABLET QD
111447146 11144714 14 C WYPAX LORAZEPAM 1 Oral 1 MG 0 1 MG TABLET QD
111447146 11144714 15 C LENDORMIN D BROTIZOLAM 1 Oral 0.25 MG 0 .25 MG TABLET QD
111447146 11144714 16 C DENOTAS CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE 1 Oral 0 TABLET QD
111447146 11144714 17 C RINDERON V BETAMETHASONE VALERATE 1 Oral 0.5 MG Y 0 .5 MG TABLET QD
111447146 11144714 18 C MAGMITT MAGNESIUM OXIDE 1 Oral 1650 MG 0 1650 MG TABLET QD
111447146 11144714 19 C LOXONIN LOXOPROFEN SODIUM 1 Oral 180 MG 0 180 MG TABLET QD
111447146 11144714 20 C MINOMYCIN MINOCYCLINE HYDROCHLORIDE 1 Oral 200 MG 0 200 MG CAPSULE QD
111447146 11144714 21 C ABSTRAL FENTANYL CITRATE 1 Other 100 MCG 0 100 UG TABLET QD
111447146 11144714 22 C ALMETA ALCLOMETASONE DIPROPIONATE 1 Unknown D 0 QD
111447146 11144714 23 C ALMETA ALCLOMETASONE DIPROPIONATE 1 Unknown UNK D 0 QD
111447146 11144714 24 C MYSER DIFLUPREDNATE 1 Unknown D 0 QD
111447146 11144714 25 C MYSER DIFLUPREDNATE 1 Unknown UNK D 0 QD
111447146 11144714 26 C HIRUDOID GLYCOSAMINOGLYCANS 1 Unknown D 0 QD
111447146 11144714 27 C HIRUDOID GLYCOSAMINOGLYCANS 1 Unknown UNK D 0 QD
111447146 11144714 28 C RINDERON VG BETAMETHASONE VALERATEGENTAMICIN SULFATE 1 Unknown D 0 ORAL SOLUTION QD
111447146 11144714 29 C RINDERON VG BETAMETHASONE VALERATEGENTAMICIN SULFATE 1 Unknown D 0 ORAL SOLUTION QD
111447146 11144714 30 C DIFFERIN ADAPALENE 1 Unknown D 0 GEL QD
111447146 11144714 31 C DIFFERIN ADAPALENE 1 Unknown D 0 GEL QD
111447146 11144714 32 C BEVACIZUMAB(GENETICAL RECOMBINATION) BEVACIZUMAB 1 Unknown 0.7143 CLI-33 U 0 15 MG/KG Q3W

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
111447146 11144714 1 Lung adenocarcinoma
111447146 11144714 4 Product used for unknown indication
111447146 11144714 5 Product used for unknown indication
111447146 11144714 6 Lung adenocarcinoma
111447146 11144714 7 Prophylaxis
111447146 11144714 8 Product used for unknown indication
111447146 11144714 9 Product used for unknown indication
111447146 11144714 10 Product used for unknown indication
111447146 11144714 11 Prophylaxis
111447146 11144714 12 Product used for unknown indication
111447146 11144714 13 Product used for unknown indication
111447146 11144714 14 Product used for unknown indication
111447146 11144714 15 Product used for unknown indication
111447146 11144714 16 Prophylaxis
111447146 11144714 17 Product used for unknown indication
111447146 11144714 18 Product used for unknown indication
111447146 11144714 19 Product used for unknown indication
111447146 11144714 20 Prophylaxis
111447146 11144714 21 Product used for unknown indication
111447146 11144714 22 Prophylaxis
111447146 11144714 24 Prophylaxis
111447146 11144714 26 Prophylaxis
111447146 11144714 28 Prophylaxis
111447146 11144714 30 Prophylaxis
111447146 11144714 32 Lung adenocarcinoma

Outcome of event

Event ID CASEID OUTC COD
111447146 11144714 DE
111447146 11144714 HO
111447146 11144714 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
111447146 11144714 Adrenal insufficiency
111447146 11144714 Anaemia
111447146 11144714 Ascites
111447146 11144714 Constipation
111447146 11144714 Dehydration
111447146 11144714 Delirium
111447146 11144714 Diarrhoea
111447146 11144714 Disorientation
111447146 11144714 Dysgeusia
111447146 11144714 Dyspnoea
111447146 11144714 Hepatic failure
111447146 11144714 Hypoparathyroidism
111447146 11144714 Hypophagia
111447146 11144714 Infection
111447146 11144714 Jaundice cholestatic
111447146 11144714 Liver disorder
111447146 11144714 Malaise
111447146 11144714 Malignant neoplasm progression
111447146 11144714 Malnutrition
111447146 11144714 Nausea
111447146 11144714 Oedema
111447146 11144714 Pain
111447146 11144714 Palmar-plantar erythrodysaesthesia syndrome
111447146 11144714 Paronychia
111447146 11144714 Pericardial effusion
111447146 11144714 Pleural effusion
111447146 11144714 Rash
111447146 11144714 Stomatitis

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
111447146 11144714 1 20141023 20141105 0
111447146 11144714 2 20141127 20141213 0
111447146 11144714 3 20141225 20150108 0
111447146 11144714 6 20141023 0
111447146 11144714 17 20141118 0
111447146 11144714 22 20141023 0
111447146 11144714 23 20141030 0
111447146 11144714 24 20141023 0
111447146 11144714 25 20141030 0
111447146 11144714 26 20141023 0
111447146 11144714 27 20141030 0
111447146 11144714 28 20141023 0
111447146 11144714 29 20141030 0
111447146 11144714 30 20141023 0
111447146 11144714 31 20141030 0
111447146 11144714 32 20141023 20141225 0