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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126301312 | 12630131 | 2 | F | 20160809 | 20160808 | 20160819 | EXP | ES-IMPAX LABORATORIES, INC-2016-IPXL-00828 | IMPAX | 56.00 | YR | M | Y | 0.00000 | 20160819 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126301312 | 12630131 | 1 | PS | LEUCOVORIN CALCIUM. | LEUCOVORIN CALCIUM | 1 | Unknown | 10TH CYCLE | Y | 74544 | TABLET | ||||||||
| 126301312 | 12630131 | 2 | SS | LEUCOVORIN CALCIUM. | LEUCOVORIN CALCIUM | 1 | Unknown | 11TH CYCLE | Y | 74544 | TABLET | ||||||||
| 126301312 | 12630131 | 3 | SS | LEUCOVORIN CALCIUM. | LEUCOVORIN CALCIUM | 1 | 12TH CYCLE | Y | 74544 | TABLET | |||||||||
| 126301312 | 12630131 | 4 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | 10TH CYCLE | 0 | ||||||||||
| 126301312 | 12630131 | 5 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | 11TH CYCLE, INFUSION RATE REDUCE BY 50% | 0 | ||||||||||
| 126301312 | 12630131 | 6 | C | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | 0 | |||||||||||
| 126301312 | 12630131 | 7 | C | IRINOTECAN HYDROCHLORIDE. | IRINOTECAN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 126301312 | 12630131 | 8 | C | AFLIBERCEPT | AFLIBERCEPT | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126301312 | 12630131 | 1 | Colon cancer |
| 126301312 | 12630131 | 4 | Colon cancer |
| 126301312 | 12630131 | 6 | Colon cancer |
| 126301312 | 12630131 | 7 | Colon cancer |
| 126301312 | 12630131 | 8 | Colon cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126301312 | 12630131 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126301312 | 12630131 | Abdominal pain | |
| 126301312 | 12630131 | Drug hypersensitivity | |
| 126301312 | 12630131 | Dyspnoea | |
| 126301312 | 12630131 | Erythema | |
| 126301312 | 12630131 | Feeling hot | |
| 126301312 | 12630131 | Oedema | |
| 126301312 | 12630131 | Pruritus |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |