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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125386591 | 12538659 | 1 | I | 20120821 | 20160708 | 20160708 | EXP | FR-CIPLA LTD.-2013FR00013 | CIPLA | 0.00 | A | Y | 0.00000 | 20160708 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125386591 | 12538659 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2, OVER 90 MIN | U | U | 77219 | 180 | MG/M**2 | ||||||
| 125386591 | 12538659 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, ON DAY 1 | U | U | 0 | 400 | MG/M**2 | ||||||
| 125386591 | 12538659 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 2400 MG/M2, A CONTINUOUS INFUSION OVER 46 H | U | U | 0 | 2400 | MG/M**2 | ||||||
| 125386591 | 12538659 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 2400 MG/M2, A CONTINUOUS INFUSION OVER 46 H | U | U | 0 | 2400 | MG/M**2 | ||||||
| 125386591 | 12538659 | 5 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | 200 MG/M2, OVER 2 H | U | U | 0 | 200 | MG/M**2 | ||||||
| 125386591 | 12538659 | 6 | C | Granisetron | GRANISETRON | 1 | Unknown | 3 MG, 15 MIN BEFORE THE ADMINISTRATION OF IRINOTECAN | U | U | 0 | 3 | MG | ||||||
| 125386591 | 12538659 | 7 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 120 MG, 15 MIN BEFORE THE ADMINISTRATION OF IRINOTECAN. | U | U | 0 | 120 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125386591 | 12538659 | 1 | Oesophageal adenocarcinoma |
| 125386591 | 12538659 | 3 | Oesophageal adenocarcinoma |
| 125386591 | 12538659 | 4 | Oesophageal adenocarcinoma |
| 125386591 | 12538659 | 5 | Oesophageal adenocarcinoma |
| 125386591 | 12538659 | 6 | Antiemetic supportive care |
| 125386591 | 12538659 | 7 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125386591 | 12538659 | OT |
| 125386591 | 12538659 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125386591 | 12538659 | Confusional state | |
| 125386591 | 12538659 | Dehydration | |
| 125386591 | 12538659 | Diarrhoea | |
| 125386591 | 12538659 | Disease progression | |
| 125386591 | 12538659 | Metastases to central nervous system |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |