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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125564011 | 12556401 | 1 | I | 20120508 | 20160714 | 20160714 | EXP | DK-CIPLA LTD.-2012DK00487 | CIPLA | SCHONNEMANN KR, YILMAZ M, BJERREGAARD JK, NIELSEN KM, PFEIFFER P.. PHASE II STUDY OF BIWEEKLY CETUXIMAB IN COMBINATION WITH IRINOTECAN AS SECOND-LINE TREATMENT IN PATIENTS WITH PLATINUM-RESISTANT GASTRO-OESOPHAGEAL CANCER. EUROPEAN JOURNAL OF CANCER. 2012;48:510 TO 517 | 0.00 | Y | 0.00000 | 20160714 | OT | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125564011 | 12556401 | 1 | PS | Irinotecan | IRINOTECAN | 1 | 180 MG/M2, ON DAY 1 EVERY SECOND WEEK | U | U | 77219 | 180 | MG/M**2 | |||||||
| 125564011 | 12556401 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125564011 | 12556401 | 3 | SS | Epirubicin | EPIRUBICIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125564011 | 12556401 | 4 | SS | CAPECITABINE. | CAPECITABINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125564011 | 12556401 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125564011 | 12556401 | 6 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125564011 | 12556401 | 7 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125564011 | 12556401 | 8 | SS | Cetuximab | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 500 MG/M2, DAY 1, WEEK 1 | U | U | 0 | 500 | MG/M**2 | ||||||
| 125564011 | 12556401 | 9 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125564011 | 12556401 | 10 | C | Ondansetron | ONDANSETRON | 1 | Oral | 8 MG, BID PRIOR TO CHEMOTHERAPY | U | U | 0 | 8 | MG | ||||||
| 125564011 | 12556401 | 11 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 100 MG, PRIOR TO CHEMOTHERAPY | U | U | 0 | 100 | MG | ||||||
| 125564011 | 12556401 | 12 | SS | Clemastine | CLEMASTINE | 1 | Intravenous (not otherwise specified) | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125564011 | 12556401 | 1 | Gastrooesophageal cancer |
| 125564011 | 12556401 | 2 | Gastrooesophageal cancer |
| 125564011 | 12556401 | 3 | Gastrooesophageal cancer |
| 125564011 | 12556401 | 4 | Gastrooesophageal cancer |
| 125564011 | 12556401 | 5 | Gastrooesophageal cancer |
| 125564011 | 12556401 | 6 | Gastrooesophageal cancer |
| 125564011 | 12556401 | 7 | Gastrooesophageal cancer |
| 125564011 | 12556401 | 9 | Gastrooesophageal cancer |
| 125564011 | 12556401 | 10 | Antiemetic supportive care |
| 125564011 | 12556401 | 11 | Antiemetic supportive care |
| 125564011 | 12556401 | 12 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125564011 | 12556401 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125564011 | 12556401 | Disease progression | |
| 125564011 | 12556401 | Febrile neutropenia | |
| 125564011 | 12556401 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |