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
109311759 10931175 9 F 201507 20160823 20150319 20160831 EXP US-PFIZER INC-2015092663 PFIZER 82.00 YR M Y 82.00000 KG 20160831 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
109311759 10931175 1 PS SUTENT SUNITINIB MALATE 1 50 MG, CYCLIC, 28 DAYS ON, 14 DAYS OFF Y 21938 50 MG CAPSULE, HARD
109311759 10931175 2 SS SUTENT SUNITINIB MALATE 1 50 MG, CYCLIC DAILY FOR 28 DAYS ON, 21 DAYS OFF Y 21938 50 MG CAPSULE, HARD
109311759 10931175 3 SS SUTENT SUNITINIB MALATE 1 50 MG ONCE A DAY, CYCLIC (28 DAYS 15 ON 15 OFF) Y Z169A 21938 50 MG CAPSULE, HARD
109311759 10931175 4 SS SUTENT SUNITINIB MALATE 1 50 MG, DAILY, FOR 2 WEEKS ON AND 2 WEEKS OFF) Y Z169A 21938 50 MG CAPSULE, HARD
109311759 10931175 5 SS SUTENT SUNITINIB MALATE 1 50 MG, DAILY, FOR 1 WEEK ON AND 1 WEEK OFF) Y Z169A 21938 50 MG CAPSULE, HARD
109311759 10931175 6 SS SUTENT SUNITINIB MALATE 1 Oral 37.5 MG, CYCLIC (5 ON 5 OFF)(ONE WEEK ON AND ONE WEEK OFF) Y 21938 37.5 MG CAPSULE, HARD
109311759 10931175 7 SS SUTENT SUNITINIB MALATE 1 Oral 37.5 MG, CYCLIC (ONE WEEK ON AND ONE WEEK OFF,1 DOSE DAILY) Y 21938 37.5 MG CAPSULE, HARD
109311759 10931175 8 SS SUTENT SUNITINIB MALATE 1 Oral 37.5 MG, CYCLIC (1 WEEK ON AND 1 WEEK OFF,1 DOSE PO DAILY) Y 21938 37.5 MG CAPSULE, HARD
109311759 10931175 9 SS SUTENT SUNITINIB MALATE 1 Oral 25 MG, CYCLIC (QDAY 1 WEEK ON 1 WEEK OFF) Y 21938 25 MG CAPSULE, HARD
109311759 10931175 10 C ASPIRIN. ASPIRIN 1 81 MG, ALTERNATE DAY (ONE EVERY OTHER DAY) 0 81 MG QOD
109311759 10931175 11 C PROPAFENONE. PROPAFENONE 1 150 MG, 2X/DAY 0 150 MG TABLET BID
109311759 10931175 12 C PROPAFENONE. PROPAFENONE 1 Oral 150 MG, 2X/DAY 0 150 MG TABLET BID
109311759 10931175 13 C AMLODIPINE AMLODIPINE BESYLATE 1 UNK 0 TABLET
109311759 10931175 14 C AMLODIPINE AMLODIPINE BESYLATE 1 Oral 10 MG, 1X/DAY 0 10 MG TABLET QD
109311759 10931175 15 C RANITIDINE. RANITIDINE 1 150 MG, AS NEEDED 0 150 MG
109311759 10931175 16 C METOCLOPRAMIDE. METOCLOPRAMIDE 1 10 MG, 1X/DAY 0 10 MG QD
109311759 10931175 17 C TIROSINT LEVOTHYROXINE SODIUM 1 UNK 0
109311759 10931175 18 C LISINOPRIL. LISINOPRIL 1 UNK 0
109311759 10931175 19 C HCTZ HYDROCHLOROTHIAZIDE 1 12.5 MG, 1X/DAY 0 12.5 MG QD
109311759 10931175 20 C SIMVASTATIN. SIMVASTATIN 1 20 MG, 1X/DAY 0 20 MG TABLET QD
109311759 10931175 21 C SIMVASTATIN. SIMVASTATIN 1 Oral 20 MG, DAILY 0 20 MG TABLET
109311759 10931175 22 C MAGNESIUM MAGNESIUM 1 UNK 0 TABLET
109311759 10931175 23 C MAGNESIUM MAGNESIUM 1 Oral 250 MG, 2X/DAY 0 250 MG TABLET BID
109311759 10931175 24 C VITAMIN B12 CYANOCOBALAMIN 1 1000 MG, 1X/DAY 0 1000 MG TABLET QD
109311759 10931175 25 C AMLODIPINE BESILATE AMLODIPINE BESYLATE 1 10 MG, 1X/DAY 0 10 MG QD
109311759 10931175 26 C LEVOTHYROXINE SODIUM. LEVOTHYROXINE SODIUM 1 50 MG, 1X/DAY 0 50 MG CAPSULE QD
109311759 10931175 27 C FUROSEMIDE. FUROSEMIDE 1 20 MG, 1X/DAY 0 20 MG TABLET QD
109311759 10931175 28 C FUROSEMIDE. FUROSEMIDE 1 UNK 0 TABLET
109311759 10931175 29 C FUROSEMIDE. FUROSEMIDE 1 Oral 40 MG, DAILY 0 40 MG TABLET
109311759 10931175 30 C CETIRIZINE CETIRIZINE HYDROCHLORIDE 1 5 MG, UNK 0 5 MG
109311759 10931175 31 C LOSARTAN. LOSARTAN 1 50 MG, UNK 0 50 MG TABLET
109311759 10931175 32 C LOSARTAN. LOSARTAN 1 Oral 50 MG, DAILY 0 50 MG TABLET
109311759 10931175 33 C HYDROCHLOROTHIAZIDE. HYDROCHLOROTHIAZIDE 1 125 MG, DAILY 0 125 MG
109311759 10931175 34 C ASPIR 81 2 Oral 81 MG, DAILY 0 81 MG PROLONGED-RELEASE TABLET
109311759 10931175 35 C BIDIL HYDRALAZINE HYDROCHLORIDEISOSORBIDE DINITRATE 1 Oral 40 MG, 2X/DAY (HYDRALAZINE HYDROCHLORIDE-37.5 MG/ ISOSORBIDE DINITRATE-20 MG) 0 40 MG TABLET BID
109311759 10931175 36 C LEVOTHYROXINE. LEVOTHYROXINE 1 Oral 50 UG, 1X/DAY 0 50 UG TABLET QD
109311759 10931175 37 C LEVOTHYROXINE. LEVOTHYROXINE 1 Oral 50 UG, 1X/DAY 0 50 UG TABLET QD
109311759 10931175 38 C NYSTATIN. NYSTATIN 1 Topical UNK UNK, 2X/DAY (100,000 UNIT/GRAM, APPLY TO GROIN AND SCROTUM ) 0 CREAM BID
109311759 10931175 39 C VITAMIN B12 + FOLIC ACID 2 Oral 1 DF, 1X/DAY (CYANOCOBALAMIN-500 MCG/FOLIC ACID-400 MCG) 0 1 DF TABLET QD
109311759 10931175 40 C ALLOPURINOL. ALLOPURINOL 1 Oral 100 MG, DAILY 0 100 MG TABLET

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
109311759 10931175 1 Metastatic renal cell carcinoma
109311759 10931175 10 Anticoagulant therapy
109311759 10931175 11 Arrhythmia
109311759 10931175 15 Abdominal discomfort
109311759 10931175 16 Abdominal discomfort
109311759 10931175 20 Blood cholesterol increased
109311759 10931175 24 Limb discomfort
109311759 10931175 25 Hypertension
109311759 10931175 26 Thyroid disorder

Outcome of event

Event ID CASEID OUTC COD
109311759 10931175 HO
109311759 10931175 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
109311759 10931175 Asthenia
109311759 10931175 Blood pressure increased
109311759 10931175 Chronic kidney disease
109311759 10931175 Constipation
109311759 10931175 Diarrhoea
109311759 10931175 Dry skin
109311759 10931175 Epistaxis
109311759 10931175 Fatigue
109311759 10931175 Gout
109311759 10931175 Haematemesis
109311759 10931175 Nausea
109311759 10931175 Pruritus
109311759 10931175 Rash
109311759 10931175 Renal impairment
109311759 10931175 Skin burning sensation
109311759 10931175 Skin exfoliation
109311759 10931175 Vomiting
109311759 10931175 Weight decreased

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
109311759 10931175 1 20150213 0
109311759 10931175 3 201502 0
109311759 10931175 4 20150826 20150905 0
109311759 10931175 5 20150905 0
109311759 10931175 6 201510 0
109311759 10931175 7 20160720 0
109311759 10931175 8 20160721 0
109311759 10931175 12 20150114 0
109311759 10931175 14 20150114 0
109311759 10931175 19 20151022 0
109311759 10931175 21 20150114 0
109311759 10931175 23 20150114 0
109311759 10931175 25 20151022 0
109311759 10931175 29 20160303 0
109311759 10931175 30 20151022 0
109311759 10931175 31 20151022 0
109311759 10931175 32 20150430 0
109311759 10931175 33 20151022 0
109311759 10931175 34 20150114 0
109311759 10931175 35 20160512 0
109311759 10931175 36 20150831 0
109311759 10931175 37 20160225 0
109311759 10931175 38 20150319 0
109311759 10931175 39 20150114 0
109311759 10931175 40 20160623 0