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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109891472 | 10989147 | 2 | F | 20160805 | 20150406 | 20160819 | EXP | JP-CIPLA LTD.-2015JP02608 | CIPLA | 0.00 | Y | 0.00000 | 20160819 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109891472 | 10989147 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Unknown | 150 MG/M2, UNK | Y | U | 0 | 150 | MG/M**2 | ||||||
| 109891472 | 10989147 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | 400 MG/M2, BOLUS ON DAY 1 | U | U | 0 | 400 | MG/M**2 | ||||||
| 109891472 | 10989147 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | 2400 MG/M2, 46 HOUR CONTINUOUS INFUSION. | U | U | 0 | 2400 | MG/M**2 | |||||||
| 109891472 | 10989147 | 4 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | 85 MG/M2, UNK | Y | U | 0 | 85 | MG/M**2 | ||||||
| 109891472 | 10989147 | 5 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | 200 MG/M2, UNK | U | U | 0 | 200 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109891472 | 10989147 | 1 | Rectal adenocarcinoma |
| 109891472 | 10989147 | 2 | Rectal adenocarcinoma |
| 109891472 | 10989147 | 4 | Rectal adenocarcinoma |
| 109891472 | 10989147 | 5 | Rectal adenocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109891472 | 10989147 | HO |
| 109891472 | 10989147 | OT |
| 109891472 | 10989147 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109891472 | 10989147 | Disease progression | |
| 109891472 | 10989147 | Neutropenia | |
| 109891472 | 10989147 | Pyelonephritis | |
| 109891472 | 10989147 | Renal failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |