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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125405601 | 12540560 | 1 | I | 20160409 | 20160503 | 20160708 | 20160708 | EXP | IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-119827 | RANBAXY | 45.08 | YR | F | Y | 57.00000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125405601 | 12540560 | 1 | PS | Oxaliplatino SUN 5 mg/ml, concentrato per soluzione per infusione | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 125 MG CYCLICAL | U | U | 202922 | 125 | MG | ||||||
| 125405601 | 12540560 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | 588 MG CYCLICAL | U | U | 0 | 588 | MG | ||||||
| 125405601 | 12540560 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 3528 MG CYCLICAL | U | U | 0 | 3528 | MG | ||||||
| 125405601 | 12540560 | 4 | C | AVASTIN | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 285 MILLIGRAMMI | U | U | 0 | 285 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125405601 | 12540560 | 1 | Colon cancer metastatic |
| 125405601 | 12540560 | 2 | Colon cancer metastatic |
| 125405601 | 12540560 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125405601 | 12540560 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125405601 | 12540560 | Anaemia |
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 |
|---|---|---|---|---|---|---|
| 125405601 | 12540560 | 1 | 20160421 | 0 | ||
| 125405601 | 12540560 | 2 | 20160421 | 0 | ||
| 125405601 | 12540560 | 3 | 20160421 | 0 | ||
| 125405601 | 12540560 | 4 | 20160421 | 0 |