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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426511 | 12542651 | 1 | I | 20160624 | 20160709 | 20160709 | EXP | US-CIPLA LTD.-2016US08961 | CIPLA | 0.00 | Y | 0.00000 | 20160709 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426511 | 12542651 | 1 | SS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 120 MG/M2, ON DAY 1 | U | U | 0 | 120 | MG/M**2 | ||||||
| 125426511 | 12542651 | 2 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 500 MG/M2, ON DAY 1, BY FIXED DOSE RATE INFUSION | U | U | 78759 | 500 | MG/M**2 | ||||||
| 125426511 | 12542651 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, ON DAY 1 | U | U | 0 | 400 | MG/M**2 | ||||||
| 125426511 | 12542651 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | 1500 MG/M2, ON DAY 1 | U | U | 0 | 1500 | MG/M**2 | |||||||
| 125426511 | 12542651 | 5 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 80 MG/M2, ON DAY 2 | U | U | 0 | 80 | MG/M**2 | ||||||
| 125426511 | 12542651 | 6 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 300 MG, ON DAY 1 | U | U | 0 | 300 | MG | ||||||
| 125426511 | 12542651 | 7 | C | Warfarin | WARFARIN | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125426511 | 12542651 | 1 | Neoplasm malignant |
| 125426511 | 12542651 | 2 | Neoplasm malignant |
| 125426511 | 12542651 | 3 | Neoplasm malignant |
| 125426511 | 12542651 | 5 | Neoplasm malignant |
| 125426511 | 12542651 | 6 | Neoplasm malignant |
| 125426511 | 12542651 | 7 | Thrombosis prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125426511 | 12542651 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125426511 | 12542651 | Dehydration |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |