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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126564881 | 12656488 | 1 | I | 20160622 | 20160804 | 20160816 | 20160816 | EXP | IT-MINISAL02-370375 | IT-TEVA-683656ACC | TEVA | 65.33 | YR | M | Y | 76.00000 | KG | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126564881 | 12656488 | 1 | PS | CISPLATINO TEVA ITALIA - 1MG/ML CONCENTRATO PER SOLUZIONE PER INFUSION | CISPLATIN | 1 | Intravenous (not otherwise specified) | 135 MG CYCLICAL | Y | 74656 | 135 | MG | SOLUTION FOR INFUSION | ||||||
| 126564881 | 12656488 | 2 | SS | NAVELBINE | VINORELBINE TARTRATE | 1 | Intravenous (not otherwise specified) | 45 MG CYCLICAL | Y | 0 | 45 | MG | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126564881 | 12656488 | 1 | Lung adenocarcinoma stage II |
| 126564881 | 12656488 | 2 | Lung adenocarcinoma stage II |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126564881 | 12656488 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126564881 | 12656488 | Diarrhoea | |
| 126564881 | 12656488 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 126564881 | 12656488 | 1 | 20160615 | 20160615 | 0 | |
| 126564881 | 12656488 | 2 | 20160615 | 20160615 | 0 |