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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126183441 | 12618344 | 1 | I | 20150319 | 20160720 | 20160803 | 20160803 | EXP | IT-ACTAVIS-2016-16682 | ACTAVIS | 77.50 | YR | M | Y | 69.00000 | KG | 20160803 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126183441 | 12618344 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 320 MG, CYCLICAL | UNKNOWN | 78589 | 320 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 126183441 | 12618344 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 4320 MG, CYCLICAL | UNKNOWN | 0 | 4320 | MG | SOLUTION FOR INFUSION | ||||||
| 126183441 | 12618344 | 3 | SS | AVASTIN | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 340 MG, CYCLICAL | UNKNOWN | 0 | 340 | MG | SOLUTION FOR INFUSION | ||||||
| 126183441 | 12618344 | 4 | C | ACEQUIDE | 2 | UNK | UNKNOWN | 0 | |||||||||||
| 126183441 | 12618344 | 5 | C | LEDERFOLIN | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | 360 MG, DAILY | 52198 | MG | UNKNOWN | 0 | 360 | MG | SOLUTION FOR INFUSION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126183441 | 12618344 | 1 | Rectal adenocarcinoma |
| 126183441 | 12618344 | 2 | Rectal adenocarcinoma |
| 126183441 | 12618344 | 3 | Rectal adenocarcinoma |
| 126183441 | 12618344 | 4 | Product used for unknown indication |
| 126183441 | 12618344 | 5 | Rectal adenocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126183441 | 12618344 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126183441 | 12618344 | Abdominal pain | |
| 126183441 | 12618344 | Muscle spasms | |
| 126183441 | 12618344 | Neutropenia | |
| 126183441 | 12618344 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 126183441 | 12618344 | 1 | 20150210 | 0 | ||
| 126183441 | 12618344 | 2 | 20150210 | 0 | ||
| 126183441 | 12618344 | 3 | 20150210 | 0 | ||
| 126183441 | 12618344 | 5 | 20150210 | 20150728 | 0 |