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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127230041 | 12723004 | 1 | I | 20160817 | 20160908 | 20160908 | EXP | JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-122845 | RANBAXY | KITADE H, HIROMASA-YAMASAKI A, HOKKOKU K, MORI M, WATANABE M, NAKAI M, ET AL. ELEVATED PROTHROMBIN TIME/INTERNATIONAL NORMALIZED RATIO ASSOCIATED WITH CONCURRENT ADMINISTRATION OF REGORAFENIB AND WARFARIN IN A PATIENT WITH ADVANCED COLORECTAL CANCER. J-PHARM-HEALTH-CARE-SCI. 2016;2(15) | 76.00 | YR | M | Y | 0.00000 | 20160908 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127230041 | 12723004 | 1 | I | Warfarin | WARFARIN | 1 | Unknown | 2 MG, DAILY | Y | N | 0 | 2 | MG | ||||||
| 127230041 | 12723004 | 2 | I | Warfarin | WARFARIN | 1 | Unknown | 1 MG, DAILY | Y | N | 0 | 1 | MG | ||||||
| 127230041 | 12723004 | 3 | I | Warfarin | WARFARIN | 1 | Unknown | 1.5 MG, DAILY (INCREASED UP TO 1.5 MG/DAY) | Y | N | 0 | 1.5 | MG | ||||||
| 127230041 | 12723004 | 4 | I | Warfarin | WARFARIN | 1 | Unknown | 0.5 MG, DAILY | Y | N | 0 | .5 | MG | ||||||
| 127230041 | 12723004 | 5 | I | Warfarin | WARFARIN | 1 | 1 MG, DAILY | Y | N | 0 | 1 | MG | |||||||
| 127230041 | 12723004 | 6 | I | Warfarin | WARFARIN | 1 | 1.5 MG, DAILY | Y | N | 0 | 1.5 | MG | |||||||
| 127230041 | 12723004 | 7 | I | Warfarin | WARFARIN | 1 | 1 MG, DAILY | Y | N | 0 | 1 | MG | |||||||
| 127230041 | 12723004 | 8 | I | Regorafenib | REGORAFENIB | 1 | Unknown | 120 MG, DAILY, ON DAYS 1 TO 21 EVERY 4 WEEKS | Y | Y | 0 | 120 | MG | ||||||
| 127230041 | 12723004 | 9 | I | Regorafenib | REGORAFENIB | 1 | Unknown | 80 MG, DAILY, ON DAYS 1 TO 14 EVERY 3 WEEKS | Y | Y | 0 | 80 | MG | ||||||
| 127230041 | 12723004 | 10 | PS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | 85 MG/M2, UNK | U | U | 202922 | 85 | MG/M**2 | ||||||
| 127230041 | 12723004 | 11 | SS | Calcium folinat | LEUCOVORIN CALCIUM | 1 | Unknown | 200 MG/M2, UNK | U | U | 0 | 200 | MG/M**2 | ||||||
| 127230041 | 12723004 | 12 | SS | 5-fluorouracil | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2 BOLUS ON DAY 1 | U | U | 0 | 400 | MG/M**2 | ||||||
| 127230041 | 12723004 | 13 | SS | 5-fluorouracil | FLUOROURACIL | 1 | 2400 MG/M2, OVER 46 H EVERY 2 WEEKS | U | U | 0 | 2400 | MG/M**2 | |||||||
| 127230041 | 12723004 | 14 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | 125 MG/M2, ON DAYS 1 AND 15 | Y | U | 0 | 125 | MG/M**2 | ||||||
| 127230041 | 12723004 | 15 | SS | TS-1 | GIMERACILOTERACILTEGAFUR | 1 | Unknown | 40 MG, BID FOR 2 WEEKS | Y | U | 0 | 40 | MG | Q12H | |||||
| 127230041 | 12723004 | 16 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 75 ?G, DAILY | U | U | 0 | 75 | UG | ||||||
| 127230041 | 12723004 | 17 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | 25 MG, DAILY | U | U | 0 | 25 | MG | ||||||
| 127230041 | 12723004 | 18 | C | Nicorandil | NICORANDIL | 1 | Unknown | 10 MG, DAILY | U | U | 0 | 10 | MG | ||||||
| 127230041 | 12723004 | 19 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | 5 MG, DAILY | U | U | 0 | 5 | MG | ||||||
| 127230041 | 12723004 | 20 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 200 MG, DAILY | U | U | 0 | 200 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127230041 | 12723004 | 1 | Myocardial infarction |
| 127230041 | 12723004 | 8 | Colon cancer metastatic |
| 127230041 | 12723004 | 10 | Metastases to liver |
| 127230041 | 12723004 | 11 | Metastases to liver |
| 127230041 | 12723004 | 12 | Metastases to liver |
| 127230041 | 12723004 | 14 | Metastases to liver |
| 127230041 | 12723004 | 15 | Metastases to liver |
| 127230041 | 12723004 | 16 | Product used for unknown indication |
| 127230041 | 12723004 | 17 | Product used for unknown indication |
| 127230041 | 12723004 | 18 | Product used for unknown indication |
| 127230041 | 12723004 | 19 | Product used for unknown indication |
| 127230041 | 12723004 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127230041 | 12723004 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127230041 | 12723004 | Disease progression | |
| 127230041 | 12723004 | Drug interaction | Drug interaction |
| 127230041 | 12723004 | International normalised ratio increased | International normalised ratio increased |
| 127230041 | 12723004 | Interstitial lung disease | |
| 127230041 | 12723004 | Palmar-plantar erythrodysaesthesia syndrome | |
| 127230041 | 12723004 | Pneumothorax | |
| 127230041 | 12723004 | Prothrombin time prolonged | Prothrombin time prolonged |
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 |
|---|---|---|---|---|---|---|
| 127230041 | 12723004 | 10 | 201207 | 0 |