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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126500301 | 12650030 | 1 | I | 20160624 | 20160803 | 20160813 | 20160813 | EXP | NY20161178 | FR-ACCORD-043154 | ACCORD | 65.00 | YR | F | Y | 0.00000 | 20160813 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126500301 | 12650030 | 1 | PS | FLUOROURACILE ACCORD | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | FOLFIRINOX PROTOCOL | U | 40743 | INFUSION | ||||||||
| 126500301 | 12650030 | 2 | SS | IRINOTECAN ACCORD | IRINOTECAN | 1 | Intravenous (not otherwise specified) | FOLFIRINOX PROTOCOL | U | 79068 | INFUSION | ||||||||
| 126500301 | 12650030 | 3 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | U | 2147483647 | 1 | G | QID | |||||||
| 126500301 | 12650030 | 4 | SS | OXALIPLATINE HOSPIRA | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | FOLFIRINOX PROTOCOL | U | 0 | INFUSION | ||||||||
| 126500301 | 12650030 | 5 | SS | DUROGESIC | FENTANYL | 1 | Transdermal | STRENGTH: 50 MICROGRAMMES/HOUR (8.4 MG/21 CM3), PATCH | U | 0 | .3333 | DF | TRANSDERMAL PATCH | ||||||
| 126500301 | 12650030 | 6 | SS | ABSTRAL | FENTANYL CITRATE | 1 | Sublingual | STRENGTH: 100 MICROGRAMMES | U | 0 | 1 | DF | TABLET | QID | |||||
| 126500301 | 12650030 | 7 | C | SPASFON | PHLOROGLUCINOL | 1 | 0 | ||||||||||||
| 126500301 | 12650030 | 8 | C | LEUCOVORIN. | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 0 | INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126500301 | 12650030 | 1 | Pancreatic carcinoma metastatic |
| 126500301 | 12650030 | 2 | Pancreatic carcinoma metastatic |
| 126500301 | 12650030 | 3 | Product used for unknown indication |
| 126500301 | 12650030 | 4 | Pancreatic carcinoma metastatic |
| 126500301 | 12650030 | 5 | Product used for unknown indication |
| 126500301 | 12650030 | 6 | Product used for unknown indication |
| 126500301 | 12650030 | 8 | Pancreatic carcinoma metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126500301 | 12650030 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126500301 | 12650030 | Agranulocytosis | |
| 126500301 | 12650030 | Blood phosphorus decreased | |
| 126500301 | 12650030 | Diarrhoea | |
| 126500301 | 12650030 | Hypokalaemia | |
| 126500301 | 12650030 | Off label use | |
| 126500301 | 12650030 | Thrombocytopenia | |
| 126500301 | 12650030 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126500301 | 12650030 | 1 | 20160613 | 20160613 | 0 | |
| 126500301 | 12650030 | 2 | 20160613 | 20160613 | 0 | |
| 126500301 | 12650030 | 3 | 20160613 | 0 | ||
| 126500301 | 12650030 | 4 | 20160613 | 20160613 | 0 | |
| 126500301 | 12650030 | 5 | 201605 | 0 | ||
| 126500301 | 12650030 | 6 | 201605 | 0 | ||
| 126500301 | 12650030 | 8 | 20160613 | 20160613 | 0 |