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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124911973 | 12491197 | 3 | F | 2015 | 20160715 | 20160623 | 20160726 | EXP | TW-BAUSCH-BL-2016-014851 | BAUSCH AND LOMB | I-T L, C-J Y. AMPULLARY CARCINOMA WITH CUTANEOUS METASTASIS. J CANCER RES PRACT. 2016;3:54-7. | 55.00 | YR | M | Y | 0.00000 | 20160726 | OT | TW | TW |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124911973 | 12491197 | 1 | PS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | 20985 | |||||||||||
| 124911973 | 12491197 | 2 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | 20985 | ||||||||||||
| 124911973 | 12491197 | 3 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | 20985 | ||||||||||||
| 124911973 | 12491197 | 4 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | 0 | |||||||||||
| 124911973 | 12491197 | 5 | SS | DOCETAXEL. | DOCETAXEL | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 6 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 0 | |||||||||||
| 124911973 | 12491197 | 7 | SS | CISPLATIN. | CISPLATIN | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 8 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Unknown | 0 | |||||||||||
| 124911973 | 12491197 | 9 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 10 | SS | IRINOTECAN | IRINOTECAN | 1 | Unknown | 0 | |||||||||||
| 124911973 | 12491197 | 11 | SS | IRINOTECAN | IRINOTECAN | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 12 | SS | IRINOTECAN | IRINOTECAN | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 13 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Unknown | 0 | |||||||||||
| 124911973 | 12491197 | 14 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 15 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 16 | C | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 17 | C | TEGAFUR/URACIL | TEGAFURURACIL | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 18 | C | FLUOROURACIL. | FLUOROURACIL | 1 | 0 | ||||||||||||
| 124911973 | 12491197 | 19 | C | CETUXIMAB | CETUXIMAB | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124911973 | 12491197 | 1 | Malignant neoplasm of ampulla of Vater |
| 124911973 | 12491197 | 2 | Metastasis |
| 124911973 | 12491197 | 3 | Adenocarcinoma |
| 124911973 | 12491197 | 4 | Malignant neoplasm of ampulla of Vater |
| 124911973 | 12491197 | 5 | Adenocarcinoma |
| 124911973 | 12491197 | 6 | Malignant neoplasm of ampulla of Vater |
| 124911973 | 12491197 | 7 | Adenocarcinoma |
| 124911973 | 12491197 | 8 | Malignant neoplasm of ampulla of Vater |
| 124911973 | 12491197 | 9 | Metastasis |
| 124911973 | 12491197 | 10 | Malignant neoplasm of ampulla of Vater |
| 124911973 | 12491197 | 11 | Metastasis |
| 124911973 | 12491197 | 12 | Adenocarcinoma |
| 124911973 | 12491197 | 13 | Malignant neoplasm of ampulla of Vater |
| 124911973 | 12491197 | 14 | Metastasis |
| 124911973 | 12491197 | 15 | Adenocarcinoma |
| 124911973 | 12491197 | 16 | Product used for unknown indication |
| 124911973 | 12491197 | 17 | Product used for unknown indication |
| 124911973 | 12491197 | 18 | Product used for unknown indication |
| 124911973 | 12491197 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124911973 | 12491197 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124911973 | 12491197 | Bacteraemia | |
| 124911973 | 12491197 | Febrile neutropenia | |
| 124911973 | 12491197 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 124911973 | 12491197 | 1 | 20150617 | 0 | ||
| 124911973 | 12491197 | 4 | 20150617 | 0 | ||
| 124911973 | 12491197 | 6 | 20150617 | 0 | ||
| 124911973 | 12491197 | 8 | 20150617 | 0 | ||
| 124911973 | 12491197 | 10 | 20150617 | 0 | ||
| 124911973 | 12491197 | 13 | 20150617 | 0 | ||
| 124911973 | 12491197 | 18 | 2012 | 0 |