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
116303276 11630327 6 F 20150605 20160726 20151014 20160808 EXP FR-BAYER-2015-349836 BAYER 49.00 YR A M Y 66.00000 KG 20160808 CN FR FR

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
116303276 11630327 1 PS REGORAFENIB REGORAFENIB 1 Oral 80 MG, QD 720 MG 203085 80 MG TABLET QD
116303276 11630327 2 SS REGORAFENIB REGORAFENIB 1 Oral UNK 720 MG 203085 TABLET
116303276 11630327 3 SS REGORAFENIB REGORAFENIB 1 Oral 80 UNK, UNK 720 MG 203085 TABLET
116303276 11630327 4 SS REGORAFENIB REGORAFENIB 1 Oral LAST DOSE PRIOR TO SAE: 80 MG 720 MG 203085 TABLET
116303276 11630327 5 SS REGORAFENIB REGORAFENIB 1 Oral LAST DOSE PRIOR TO SAE: 80 MG 720 MG 203085 TABLET
116303276 11630327 6 SS REGORAFENIB REGORAFENIB 1 Oral LAST DOSE PRIOR TO SAE: 80 MG 720 MG 203085 TABLET
116303276 11630327 7 SS REGORAFENIB REGORAFENIB 1 LAST DOSE PRIOR TO SAE: 80MG 720 MG 203085 TABLET
116303276 11630327 8 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 1998 MG 0
116303276 11630327 9 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) UNK 0
116303276 11630327 10 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) LAST DOSE PRIOR TO SAE: 1600 MG 0
116303276 11630327 11 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) LAST DOSE PRIOR TO SAE: 1544 MG 0
116303276 11630327 12 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) LAST DOSE PRIOR TO SAE: 1568 MG 0
116303276 11630327 13 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 1528 MG, QD 0 1528 MG QD
116303276 11630327 14 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) 177.6 MG 0
116303276 11630327 15 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) UNK 0
116303276 11630327 16 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) LAST DOSE PRIOR TO SAE: 120 MG 0
116303276 11630327 17 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) LAST DOSE PRIOR TO SAE: 115.8 MG 0
116303276 11630327 18 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) LAST DOSE PRIOR TO SAE: 117.6 MG 0
116303276 11630327 19 SS OXALIPLATIN. OXALIPLATIN 1 Intravenous (not otherwise specified) 114.60 MG, QD 0 114.6 MG QD
116303276 11630327 20 C DOLIPRANE ACETAMINOPHEN 1 Oral UNK 0
116303276 11630327 21 C DOLIPRANE ACETAMINOPHEN 1 0
116303276 11630327 22 C DEXERYL [GLYCEROL,PARAFFIN, LIQUID,WHITE SOFT PARAFFIN] 2 UNK 0
116303276 11630327 23 C NEULASTA PEGFILGRASTIM 1 Subcutaneous UNK 0
116303276 11630327 24 C ZOVIRAX ACYCLOVIR 1 Cutaneous UNK 0
116303276 11630327 25 C MOVICOL POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE 1 Oral UNK 0
116303276 11630327 26 C INEXIUM ESOMEPRAZOLE 1 UNK 0
116303276 11630327 27 C PRIMPERAN METOCLOPRAMIDE HYDROCHLORIDE 1 UNK 0
116303276 11630327 28 C FENTANYL. FENTANYL 1 UNK 0
116303276 11630327 29 C TITANOREINE [CHONDRUS CRISPUS EXTRACT,TITANIUM DIOXIDE,ZINC OXIDE] 2 0
116303276 11630327 30 C VOGALENE METOPIMAZINE 1 UNK 0
116303276 11630327 31 C ULCAR SUCRALFATE 1 UNK 0
116303276 11630327 32 C ONDANSETRON ONDANSETRON 1 Intravenous (not otherwise specified) UNK 0
116303276 11630327 33 C PLITICAN ALIZAPRIDE HYDROCHLORIDE 1 UNK 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
116303276 11630327 1 Biliary cancer metastatic
116303276 11630327 2 Metastases to bone
116303276 11630327 3 Metastases to liver
116303276 11630327 4 Metastases to muscle
116303276 11630327 5 Biliary cancer metastatic
116303276 11630327 6 Biliary cancer metastatic
116303276 11630327 7 Biliary cancer metastatic
116303276 11630327 8 Biliary cancer metastatic
116303276 11630327 9 Metastases to bone
116303276 11630327 10 Metastases to liver
116303276 11630327 11 Metastases to muscle
116303276 11630327 12 Biliary cancer metastatic
116303276 11630327 13 Biliary cancer metastatic
116303276 11630327 14 Biliary cancer metastatic
116303276 11630327 15 Metastases to bone
116303276 11630327 16 Metastases to liver
116303276 11630327 17 Metastases to muscle
116303276 11630327 18 Biliary cancer metastatic
116303276 11630327 19 Biliary cancer metastatic
116303276 11630327 20 Arthralgia
116303276 11630327 21 Back pain
116303276 11630327 22 Dry skin prophylaxis
116303276 11630327 23 Neutropenia
116303276 11630327 24 Skin infection
116303276 11630327 25 Constipation
116303276 11630327 26 Abdominal pain upper
116303276 11630327 27 Nausea
116303276 11630327 28 Pain
116303276 11630327 29 Haemorrhoids
116303276 11630327 30 Nausea
116303276 11630327 31 Abdominal pain upper
116303276 11630327 32 Nausea
116303276 11630327 33 Nausea

Outcome of event

Event ID CASEID OUTC COD
116303276 11630327 HO
116303276 11630327 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
116303276 11630327 Abdominal pain
116303276 11630327 Anaemia
116303276 11630327 Chest pain
116303276 11630327 Fatigue
116303276 11630327 General physical health deterioration
116303276 11630327 Hypercalcaemia
116303276 11630327 Hypokalaemia
116303276 11630327 Nausea
116303276 11630327 Neck pain
116303276 11630327 Rib fracture

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
116303276 11630327 1 20150528 20150610 0
116303276 11630327 2 20150625 0
116303276 11630327 3 20150528 20150908 0
116303276 11630327 8 20150528 20150604 0
116303276 11630327 9 20150528 20150902 0
116303276 11630327 10 20150930 0
116303276 11630327 11 20151022 0
116303276 11630327 12 20151112 0
116303276 11630327 13 20151211 0
116303276 11630327 14 20150528 20150723 0
116303276 11630327 15 20150528 20150902 0
116303276 11630327 16 20150930 0
116303276 11630327 17 20151022 0
116303276 11630327 18 20151112 0
116303276 11630327 19 20151211 0
116303276 11630327 20 20150520 20150612 0
116303276 11630327 22 20150528 0
116303276 11630327 24 20150604 20150612 0
116303276 11630327 25 20150609 20150611 0
116303276 11630327 26 20150625 0
116303276 11630327 27 20150704 0
116303276 11630327 28 20150909 0
116303276 11630327 30 20150923 20151001 0
116303276 11630327 31 20150923 20151001 0
116303276 11630327 32 20151003 20151005 0
116303276 11630327 33 20151003 20151004 0