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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124317734 | 12431773 | 4 | F | 20151102 | 20160725 | 20160603 | 20160803 | EXP | JP-AMGEN-JPNCT2016023846 | AMGEN | 67.00 | YR | E | F | Y | 55.00000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124317734 | 12431773 | 1 | PS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 270 MG, Q2WK | 270 | MG | Y | 125147 | 270 | MG | SOLUTION FOR INJECTION | QOW | |||
| 124317734 | 12431773 | 2 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | UNK | 270 | MG | Y | 125147 | SOLUTION FOR INJECTION | ||||||
| 124317734 | 12431773 | 3 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 550 MG, Q2WK | 56550 | MG | U | 0 | 550 | MG | QOW | ||||
| 124317734 | 12431773 | 4 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 3550 MG/M2, Q2WK | 56550 | MG | U | 0 | 3550 | MG | QOW | ||||
| 124317734 | 12431773 | 5 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 550 MG, Q2WEEKS | 56550 | MG | U | 0 | 550 | MG | QOW | ||||
| 124317734 | 12431773 | 6 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 3350 MG, Q2WEEKS | 56550 | MG | U | 0 | 3350 | MG | QOW | ||||
| 124317734 | 12431773 | 7 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 550 MG, Q2WEEKS | 56550 | MG | U | 0 | 550 | MG | QOW | ||||
| 124317734 | 12431773 | 8 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 3350 MG, Q2WEEKS | 56550 | MG | U | 0 | 3350 | MG | QOW | ||||
| 124317734 | 12431773 | 9 | SS | ELPLAT | OXALIPLATIN | 1 | Intravenous drip | 110 MG, Q2WEEKS | 550 | MG | U | 0 | 110 | MG | QOW | ||||
| 124317734 | 12431773 | 10 | SS | ELPLAT | OXALIPLATIN | 1 | Intravenous drip | 110 MG, Q2WEEKS | 550 | MG | U | 0 | 110 | MG | QOW | ||||
| 124317734 | 12431773 | 11 | SS | ELPLAT | OXALIPLATIN | 1 | Unknown | UNK | 550 | MG | U | 0 | |||||||
| 124317734 | 12431773 | 12 | SS | ELPLAT | OXALIPLATIN | 1 | Unknown | UNK | 550 | MG | U | 0 | |||||||
| 124317734 | 12431773 | 13 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 275 MG, Q2WEEKS | U | 0 | 275 | MG | QOW | ||||||
| 124317734 | 12431773 | 14 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 275 MG, Q2WEEKS | U | 0 | 275 | MG | QOW | ||||||
| 124317734 | 12431773 | 15 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 275 MG, Q2WEEKS | U | 0 | 275 | MG | QOW | ||||||
| 124317734 | 12431773 | 16 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 124317734 | 12431773 | 17 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | U | 0 | |||||||||||
| 124317734 | 12431773 | 18 | C | ALOXI | PALONOSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0.75 MG, Q2WEEKS | U | 0 | .75 | MG | QOW | ||||||
| 124317734 | 12431773 | 19 | C | DAIKENCHUTO | HERBALS | 1 | Oral | 2.5 G, TID | U | 0 | 2.5 | G | TID | ||||||
| 124317734 | 12431773 | 20 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | Oral | 0.6 G, TID | U | 0 | .6 | G | TID | ||||||
| 124317734 | 12431773 | 21 | C | LOXOPROFEN | LOXOPROFEN | 1 | Oral | 60 MG, TID | 39960 | MG | U | 0 | 60 | MG | TID | ||||
| 124317734 | 12431773 | 22 | C | MUCOSTA | REBAMIPIDE | 1 | Oral | 100 MG, TID | 66600 | MG | U | 0 | 100 | MG | TID | ||||
| 124317734 | 12431773 | 23 | C | MINOCYCLINE HYDROCHLORIDE. | MINOCYCLINE HYDROCHLORIDE | 1 | Oral | 50 MG, BID | 21500 | MG | U | 0 | 50 | MG | BID | ||||
| 124317734 | 12431773 | 24 | C | PROMAC | NITROFURANTOIN | 1 | Oral | 75 MG, BID | 21600 | MG | U | 0 | 75 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124317734 | 12431773 | 1 | Rectal cancer stage IV |
| 124317734 | 12431773 | 2 | Metastases to lymph nodes |
| 124317734 | 12431773 | 3 | Rectal cancer stage IV |
| 124317734 | 12431773 | 4 | Metastases to lung |
| 124317734 | 12431773 | 5 | Metastases to ovary |
| 124317734 | 12431773 | 6 | Metastases to lymph nodes |
| 124317734 | 12431773 | 9 | Rectal cancer stage IV |
| 124317734 | 12431773 | 10 | Metastases to lung |
| 124317734 | 12431773 | 11 | Metastases to ovary |
| 124317734 | 12431773 | 12 | Metastases to lymph nodes |
| 124317734 | 12431773 | 13 | Colon cancer |
| 124317734 | 12431773 | 14 | Rectal cancer stage IV |
| 124317734 | 12431773 | 15 | Metastases to lung |
| 124317734 | 12431773 | 16 | Metastases to ovary |
| 124317734 | 12431773 | 17 | Metastases to lymph nodes |
| 124317734 | 12431773 | 18 | Prophylaxis |
| 124317734 | 12431773 | 22 | Gastritis prophylaxis |
| 124317734 | 12431773 | 23 | Prophylaxis |
| 124317734 | 12431773 | 24 | Dysgeusia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124317734 | 12431773 | HO |
| 124317734 | 12431773 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124317734 | 12431773 | Abdominal pain upper | |
| 124317734 | 12431773 | Alopecia | |
| 124317734 | 12431773 | Hepatic function abnormal | |
| 124317734 | 12431773 | Hypomagnesaemia | |
| 124317734 | 12431773 | Interstitial lung disease | |
| 124317734 | 12431773 | Malaise | |
| 124317734 | 12431773 | Nausea | |
| 124317734 | 12431773 | Neuropathy peripheral | |
| 124317734 | 12431773 | Neutrophil count decreased | |
| 124317734 | 12431773 | Palmar-plantar erythrodysaesthesia syndrome | |
| 124317734 | 12431773 | Platelet count decreased | |
| 124317734 | 12431773 | Stomatitis | |
| 124317734 | 12431773 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 124317734 | 12431773 | 1 | 20151016 | 20151016 | 0 | |
| 124317734 | 12431773 | 3 | 20151016 | 20151016 | 0 | |
| 124317734 | 12431773 | 4 | 20151016 | 20151016 | 0 | |
| 124317734 | 12431773 | 5 | 20151109 | 20160112 | 0 | |
| 124317734 | 12431773 | 6 | 20151109 | 20160112 | 0 | |
| 124317734 | 12431773 | 7 | 20160209 | 20160510 | 0 | |
| 124317734 | 12431773 | 8 | 20160209 | 20160510 | 0 | |
| 124317734 | 12431773 | 9 | 20151016 | 20151016 | 0 | |
| 124317734 | 12431773 | 10 | 20151109 | 20160112 | 0 | |
| 124317734 | 12431773 | 13 | 20151016 | 20151016 | 0 | |
| 124317734 | 12431773 | 14 | 20151109 | 20160112 | 0 | |
| 124317734 | 12431773 | 15 | 20160209 | 20160510 | 0 | |
| 124317734 | 12431773 | 18 | 20151016 | 20160510 | 0 | |
| 124317734 | 12431773 | 19 | 20150910 | 0 | ||
| 124317734 | 12431773 | 20 | 20160419 | 0 | ||
| 124317734 | 12431773 | 21 | 20151011 | 20160521 | 0 | |
| 124317734 | 12431773 | 22 | 20151011 | 20160521 | 0 | |
| 124317734 | 12431773 | 23 | 20151018 | 20160521 | 0 | |
| 124317734 | 12431773 | 24 | 20151228 | 20160521 | 0 |