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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125904421 | 12590442 | 1 | I | 20140521 | 20140728 | 20160725 | 20160725 | EXP | 262025 | IT-MYLANLABS-2014SP004521 | MYLAN | 0.00 | Y | 0.00000 | 20160725 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125904421 | 12590442 | 1 | PS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | U | U | 91062 | 138 | MG | |||||||
| 125904421 | 12590442 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | U | U | 0 | 6800 | MG | |||||||
| 125904421 | 12590442 | 3 | C | FERRO-GRAD | FERROUS SULFATE | 1 | 0 | ||||||||||||
| 125904421 | 12590442 | 4 | C | FOLIDEX | FOLIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125904421 | 12590442 | 1 | Gastrointestinal carcinoma |
| 125904421 | 12590442 | 2 | Gastrointestinal carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125904421 | 12590442 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125904421 | 12590442 | Product use issue | |
| 125904421 | 12590442 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 125904421 | 12590442 | 1 | 20140121 | 20140628 | 0 | |
| 125904421 | 12590442 | 2 | 20140121 | 20140628 | 0 |