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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126952601 | 12695260 | 1 | I | 20160820 | 20160829 | 20160829 | EXP | JP-MYLANLABS-2016M1036201 | MYLAN | MUNEOKA K, SHIRAI Y, SASAKI M, SAKATA J, KANDA J, WAKABAYASHI H, ET AL. INDIVIDUAL DOSE ADJUSTMENT OF 5-FLUOROURACIL BASED ON PHARMACOKINETIC MONITORING MAY IMPROVE THE OUTCOME OF FOLFOX FOR METASTATIC COLORECTAL CANCER. [JAPANESE]. GAN-TO-KAGAKU-RYOHO 2016;43(3):323-326. | 0.00 | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126952601 | 12695260 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 400MG/M2 | U | U | 202668 | INJECTION | |||||||
| 126952601 | 12695260 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | CONTINUOUS 2400 MG/M2 ADMINISTRATION | U | U | 202668 | INJECTION | |||||||
| 126952601 | 12695260 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | INCREASED TO CONTINUOUS 3000 MG/M2 ADMINISTRATION | U | U | 202668 | INJECTION | |||||||
| 126952601 | 12695260 | 4 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 85MG/M2 GIVEN OVER TWO HOURS | 0 | INJECTION | |||||||||
| 126952601 | 12695260 | 5 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous drip | 200MG/M2 GIVEN OVER TWO HOURS | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126952601 | 12695260 | 1 | Colon cancer metastatic |
| 126952601 | 12695260 | 4 | Colon cancer metastatic |
| 126952601 | 12695260 | 5 | Colon cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126952601 | 12695260 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126952601 | 12695260 | Mucosal inflammation | |
| 126952601 | 12695260 | Neuropathy peripheral |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |