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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125593612 | 12559361 | 2 | F | 20160714 | 20160715 | 20160725 | EXP | ES-ACCORD-042362 | ACCORD | MARTIN AJ, ALFONSO PG, RUPEREZ AB, JIMENEZ MM. NAB-PACLITAXEL PLUS GEMCITABINE AS FIRST-LINE PALLIATIVE CHEMOTHERAPY IN A PATIENT WITH METASTATIC PANCREATIC CANCER WITH EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS OF 2. ONCOL LETT. 2016 JUL;12(1):727-730. | 65.00 | YR | F | Y | 0.00000 | 20160725 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125593612 | 12559361 | 1 | PS | GEMCITABINE/GEMCITABINE HYDROCHLORIDE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | DAY 1, 8 AND 15?ALSO RECEIVED 400 MG/M^2 FIRST LINE PALLIATIVE CHEMOTHERAPY IN NOV-2013 EVERY 28 DA | 91594 | 1000 | MG/M**2 | ||||||||
| 125593612 | 12559361 | 2 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | U | 2147483647 | |||||||||||
| 125593612 | 12559361 | 3 | SS | PACLITAXEL/PACLITAXEL LIPOSOME | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG/M**2 | |||||||||
| 125593612 | 12559361 | 4 | SS | TEGAFUR/TEGAFUR SODIUM | TEGAFUR | 1 | Oral | U | 0 | 1200 | MG | ||||||||
| 125593612 | 12559361 | 5 | C | ENOXAPARIN | ENOXAPARIN | 1 | Subcutaneous | 1 MG/KG/12 H | 0 | ||||||||||
| 125593612 | 12559361 | 6 | C | ZOLEDRONIC ACID | ZOLEDRONIC ACID | 1 | 0 | ||||||||||||
| 125593612 | 12559361 | 7 | C | OXYCODONE/OXYCODONE HYDROCHLORIDE/OXYCODONE PECTINATE/OXYCODONE TEREPHTHALATE | 2 | Oral | GRADUALLY REDUCED TO 5 MG/12 H | 0 | 40 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125593612 | 12559361 | 1 | Pancreatic carcinoma metastatic |
| 125593612 | 12559361 | 2 | Analgesic therapy |
| 125593612 | 12559361 | 3 | Pancreatic carcinoma metastatic |
| 125593612 | 12559361 | 4 | Radiosensitisation therapy |
| 125593612 | 12559361 | 5 | Hepatic vascular thrombosis |
| 125593612 | 12559361 | 7 | Analgesic therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125593612 | 12559361 | DE |
| 125593612 | 12559361 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125593612 | 12559361 | Anaemia | |
| 125593612 | 12559361 | Asthenia | |
| 125593612 | 12559361 | Biliary dilatation | |
| 125593612 | 12559361 | Biliary tract disorder | |
| 125593612 | 12559361 | Cholangitis acute | |
| 125593612 | 12559361 | Diabetes mellitus | |
| 125593612 | 12559361 | Diarrhoea | |
| 125593612 | 12559361 | Gastroenteritis radiation | |
| 125593612 | 12559361 | HER-2 positive breast cancer | |
| 125593612 | 12559361 | Hepatotoxicity | |
| 125593612 | 12559361 | Lymphopenia | |
| 125593612 | 12559361 | Mesenteric vein thrombosis | |
| 125593612 | 12559361 | Metastases to adrenals | |
| 125593612 | 12559361 | Metastases to lymph nodes | |
| 125593612 | 12559361 | Metastases to spine | |
| 125593612 | 12559361 | Neutropenia | |
| 125593612 | 12559361 | Oedema peripheral | |
| 125593612 | 12559361 | Pancreatic insufficiency | |
| 125593612 | 12559361 | Portal vein thrombosis | |
| 125593612 | 12559361 | Pulmonary mass | |
| 125593612 | 12559361 | Refusal of treatment by patient | |
| 125593612 | 12559361 | Short-bowel syndrome | |
| 125593612 | 12559361 | Toxicity to various agents | |
| 125593612 | 12559361 | Treatment failure | |
| 125593612 | 12559361 | 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 |
|---|---|---|---|---|---|---|
| 125593612 | 12559361 | 3 | 201311 | 0 | ||
| 125593612 | 12559361 | 6 | 2013 | 0 |