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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125654271 | 12565427 | 1 | I | 20151007 | 20151201 | 20160718 | 20160718 | EXP | IT-ACTAVIS-2015-29567 | ACTAVIS | 45.90 | YR | F | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125654271 | 12565427 | 1 | PS | Irinotecan (Unknown) | IRINOTECAN | 1 | Unknown | 300 MG, CYCLICAL | U | UNKNOWN | 78589 | 300 | MG | UNK | |||||
| 125654271 | 12565427 | 2 | SS | Irinotecan (Unknown) | IRINOTECAN | 1 | Unknown | 240 MG, CYCLICAL | U | UNKNOWN | 78589 | 240 | MG | UNK | |||||
| 125654271 | 12565427 | 3 | SS | LEUCOVORIN /00566701/ | LEUCOVORIN | 1 | Unknown | 330 MG, CYCLICAL | U | UNKNOWN | 0 | 330 | MG | ||||||
| 125654271 | 12565427 | 4 | SS | LEUCOVORIN /00566701/ | LEUCOVORIN | 1 | Unknown | 260 MG, CYCLICAL | U | UNKNOWN | 0 | 260 | MG | ||||||
| 125654271 | 12565427 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 660 MG, CYCLICAL | U | UNKNOWN | 0 | 660 | MG | ||||||
| 125654271 | 12565427 | 6 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 3900 MG, CYCLICAL | U | UNKNOWN | 0 | 3900 | MG | ||||||
| 125654271 | 12565427 | 7 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 530 MG, CYCLICAL | U | UNKNOWN | 0 | 530 | MG | ||||||
| 125654271 | 12565427 | 8 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous drip | 3100 MG, CYCLICAL | U | UNKNOWN | 0 | 3100 | MG | ||||||
| 125654271 | 12565427 | 9 | SS | ZALTRAP | ZIV-AFLIBERCEPT | 1 | Intravenous (not otherwise specified) | UNK, CYCLICAL | U | UNKNOWN | 0 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125654271 | 12565427 | 10 | SS | ZALTRAP | ZIV-AFLIBERCEPT | 1 | Intravenous (not otherwise specified) | 240 MG, CYCLICAL | U | UNKNOWN | 0 | 240 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 125654271 | 12565427 | 11 | C | GRANULOCYTE COLONY STIMULATING FACTOR | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | UNK | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125654271 | 12565427 | 1 | Colorectal cancer |
| 125654271 | 12565427 | 3 | Colorectal cancer |
| 125654271 | 12565427 | 5 | Colorectal cancer |
| 125654271 | 12565427 | 9 | Colorectal cancer |
| 125654271 | 12565427 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125654271 | 12565427 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125654271 | 12565427 | Cough | |
| 125654271 | 12565427 | Nasal inflammation | |
| 125654271 | 12565427 | Rhinitis | |
| 125654271 | 12565427 | Stomatitis | |
| 125654271 | 12565427 | Tracheitis |
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 |
|---|---|---|---|---|---|---|
| 125654271 | 12565427 | 1 | 20150420 | 0 | ||
| 125654271 | 12565427 | 2 | 20151007 | 0 | ||
| 125654271 | 12565427 | 3 | 20150420 | 0 | ||
| 125654271 | 12565427 | 4 | 20151007 | 0 | ||
| 125654271 | 12565427 | 5 | 20150420 | 0 | ||
| 125654271 | 12565427 | 6 | 20150420 | 0 | ||
| 125654271 | 12565427 | 7 | 20151007 | 0 | ||
| 125654271 | 12565427 | 8 | 20151007 | 0 | ||
| 125654271 | 12565427 | 9 | 20150420 | 0 | ||
| 125654271 | 12565427 | 10 | 20151007 | 0 | ||
| 125654271 | 12565427 | 11 | 20150625 | 20150625 | 0 |