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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126067001 | 12606700 | 1 | I | 20160715 | 20160729 | 20160729 | EXP | ES-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-121206 | RANBAXY | 68.00 | YR | F | Y | 46.00000 | KG | 20160729 | OT | GB | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126067001 | 12606700 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DAYS 1, 8 AND 15; EVERY 28 DAYS | U | 78433 | 400 | MG/M**2 | |||||||
| 126067001 | 12606700 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | DAYS 1, 8 AND 15; EVERY 28 DAYS | U | 0 | 50 | MG/M**2 | |||||||
| 126067001 | 12606700 | 3 | C | OXYCODONE | OXYCODONE | 1 | Oral | 5 MG/ 12H | U | 0 | 5 | MG | Q12H | ||||||
| 126067001 | 12606700 | 4 | C | OXYCODONE | OXYCODONE | 1 | Oral | 40 MG/ 12H | U | 0 | 40 | MG | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126067001 | 12606700 | 1 | Pancreatic carcinoma metastatic |
| 126067001 | 12606700 | 2 | Pancreatic carcinoma metastatic |
| 126067001 | 12606700 | 3 | Analgesic therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126067001 | 12606700 | DE |
| 126067001 | 12606700 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126067001 | 12606700 | Anaemia | |
| 126067001 | 12606700 | Asthenia | |
| 126067001 | 12606700 | Cholangitis acute | |
| 126067001 | 12606700 | Diarrhoea | |
| 126067001 | 12606700 | Hepatotoxicity | |
| 126067001 | 12606700 | Lymphopenia | |
| 126067001 | 12606700 | Oedema peripheral | |
| 126067001 | 12606700 | Pyrexia | |
| 126067001 | 12606700 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126067001 | 12606700 | 1 | 201311 | 0 | ||
| 126067001 | 12606700 | 2 | 201311 | 0 |