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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122127445 | 12212744 | 5 | F | 20160314 | 20160721 | 20160328 | 20160725 | EXP | DE-ROCHE-1731505 | ROCHE | 69.00 | YR | M | Y | 77.00000 | KG | 20160725 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122127445 | 12212744 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125085 | 385 | MG | SOLUTION FOR INFUSION | QOW | ||||||
| 122127445 | 12212744 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SAE | Y | 125085 | 308 | MG | SOLUTION FOR INFUSION | QOW | |||||
| 122127445 | 12212744 | 3 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 0 | 780 | MG | /wk | ||||||||
| 122127445 | 12212744 | 4 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 5 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 6 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 7 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 8 | C | FOLINIC ACID | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 9 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 0 | 780 | MG | QOW | ||||||||
| 122127445 | 12212744 | 10 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 0 | 2340 | MG | QOW | ||||||||
| 122127445 | 12212744 | 11 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 12 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 0 | 1872 | MG | QOW | ||||||||
| 122127445 | 12212744 | 13 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 14 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 15 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 16 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 0 | 624 | MG | QOW | ||||||||
| 122127445 | 12212744 | 17 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 0 | 1872 | MG | QOW | ||||||||
| 122127445 | 12212744 | 18 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 0 | 1872 | MG | QOW | ||||||||
| 122127445 | 12212744 | 19 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 0 | 1872 | MG | QOW | ||||||||
| 122127445 | 12212744 | 20 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 0 | 1872 | MG | QOW | ||||||||
| 122127445 | 12212744 | 21 | C | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 0 | 350 | MG | QOW | ||||||||
| 122127445 | 12212744 | 22 | C | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 0 | 280 | MG | QOW | ||||||||
| 122127445 | 12212744 | 23 | C | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 0 | 280 | MG | QOW | ||||||||
| 122127445 | 12212744 | 24 | C | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 0 | 280 | MG | QOW | ||||||||
| 122127445 | 12212744 | 25 | C | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 0 | 280 | MG | QOW | ||||||||
| 122127445 | 12212744 | 26 | C | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 0 | 280 | MG | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122127445 | 12212744 | 1 | Colorectal cancer |
| 122127445 | 12212744 | 3 | Colorectal cancer |
| 122127445 | 12212744 | 9 | Colorectal cancer |
| 122127445 | 12212744 | 21 | Colorectal cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122127445 | 12212744 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122127445 | 12212744 | Decreased appetite | |
| 122127445 | 12212744 | Diarrhoea | |
| 122127445 | 12212744 | Fungal infection | |
| 122127445 | 12212744 | General physical health deterioration | |
| 122127445 | 12212744 | Monoparesis | |
| 122127445 | 12212744 | Pain | |
| 122127445 | 12212744 | Prerenal failure | |
| 122127445 | 12212744 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 122127445 | 12212744 | 1 | 20160314 | 0 | ||
| 122127445 | 12212744 | 2 | 20160608 | 0 | ||
| 122127445 | 12212744 | 3 | 20160314 | 20160314 | 0 | |
| 122127445 | 12212744 | 4 | 20160413 | 0 | ||
| 122127445 | 12212744 | 5 | 20140427 | 20140427 | 0 | |
| 122127445 | 12212744 | 6 | 20160511 | 20160511 | 0 | |
| 122127445 | 12212744 | 7 | 20160525 | 20160525 | 0 | |
| 122127445 | 12212744 | 8 | 20160608 | 20160608 | 0 | |
| 122127445 | 12212744 | 9 | 20160314 | 20160314 | 0 | |
| 122127445 | 12212744 | 10 | 20160314 | 20160316 | 0 | |
| 122127445 | 12212744 | 11 | 20160413 | 0 | ||
| 122127445 | 12212744 | 12 | 20160413 | 0 | ||
| 122127445 | 12212744 | 13 | 20160427 | 20160427 | 0 | |
| 122127445 | 12212744 | 14 | 20160511 | 20160511 | 0 | |
| 122127445 | 12212744 | 15 | 20160525 | 20160525 | 0 | |
| 122127445 | 12212744 | 16 | 20160608 | 20160608 | 0 | |
| 122127445 | 12212744 | 17 | 20160427 | 20160427 | 0 | |
| 122127445 | 12212744 | 18 | 20160511 | 20160511 | 0 | |
| 122127445 | 12212744 | 19 | 20160525 | 20160525 | 0 | |
| 122127445 | 12212744 | 20 | 20160608 | 20160610 | 0 | |
| 122127445 | 12212744 | 21 | 20160314 | 20160314 | 0 | |
| 122127445 | 12212744 | 22 | 20160413 | 0 | ||
| 122127445 | 12212744 | 23 | 20160427 | 20160427 | 0 | |
| 122127445 | 12212744 | 24 | 20160511 | 20160511 | 0 | |
| 122127445 | 12212744 | 25 | 20160525 | 20160525 | 0 | |
| 122127445 | 12212744 | 26 | 20160608 | 20160608 | 0 |