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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125904431 | 12590443 | 1 | I | 20140607 | 20140820 | 20160725 | 20160725 | EXP | IT-MYLANLABS-2014SP005024 | MYLAN | 0.00 | Y | 0.00000 | 20160725 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125904431 | 12590443 | 1 | PS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | U | U | 91062 | 100 | MG/M**2 | |||||||
| 125904431 | 12590443 | 2 | C | FLUOROURACIL. | FLUOROURACIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125904431 | 12590443 | 1 | Squamous cell carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125904431 | 12590443 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125904431 | 12590443 | Blood creatinine increased | |
| 125904431 | 12590443 | Hyperkalaemia | |
| 125904431 | 12590443 | Hyperuricaemia | |
| 125904431 | 12590443 | Hyponatraemia |
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 |
|---|---|---|---|---|---|---|
| 125904431 | 12590443 | 1 | 20140204 | 20140426 | 0 | |
| 125904431 | 12590443 | 2 | 20140204 | 20140426 | 0 |