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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426461 | 12542646 | 1 | I | 20160624 | 20160709 | 20160709 | EXP | AU-CIPLA LTD.-2016AU08331 | CIPLA | 0.00 | Y | 0.00000 | 20160709 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426461 | 12542646 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | 1000 MG/M2, ON DAYS 1 AND 8 OF EACH 21 DAY CYCLE | U | U | 78759 | 1000 | MG/M**2 | ||||||
| 125426461 | 12542646 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 25 MG/M2, ON DAYS 1 AND 8 OF EACH 21 DAY CYCLE | U | U | 0 | 25 | MG/M**2 | ||||||
| 125426461 | 12542646 | 3 | SS | Panitumumab | PANITUMUMAB | 1 | Unknown | 9 MG/KG, ON DAY 1 OF EACH 21 DAY CYCLE | U | U | 0 | 9 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125426461 | 12542646 | 1 | Biliary neoplasm |
| 125426461 | 12542646 | 2 | Biliary neoplasm |
| 125426461 | 12542646 | 3 | Biliary neoplasm |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125426461 | 12542646 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125426461 | 12542646 | Febrile neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |