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 |