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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125829781 | 12582978 | 1 | I | 20160708 | 20160722 | 20160722 | EXP | ES-CIPLA LTD.-2016ES09816 | CIPLA | MARTIN MAJ, 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. ONCOLOGY LETTERS. 2016;12:727 TO 730 | 0.00 | Y | 0.00000 | 20160722 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125829781 | 12582978 | 1 | PS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 MG/M2, DAYS 1, 8 AND 15 | 0 | 1000 | MG/M**2 | ||||||||
| 125829781 | 12582978 | 2 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 400 MG/M2, ON DAYS 1, 8 AND 15, FOR 3 CYCLES | 0 | 400 | MG/M**2 | ||||||||
| 125829781 | 12582978 | 3 | SS | ANASTROZOLE. | ANASTROZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125829781 | 12582978 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 600 MG/M2, EVERY 21 DAYS | 0 | 600 | MG/M**2 | ||||||||
| 125829781 | 12582978 | 5 | SS | LETROZOLE. | LETROZOLE | 1 | Oral | UNK | 0 | ||||||||||
| 125829781 | 12582978 | 6 | SS | Zoledronic acid | ZOLEDRONIC ACID | 1 | Unknown | 4 MG, EVERY 28 DAYS | 0 | 4 | MG | ||||||||
| 125829781 | 12582978 | 7 | SS | Enoxaparin | ENOXAPARIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125829781 | 12582978 | 8 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 50 MG/M2, DAYS 1, 8 AND 15 | 0 | 50 | MG/M**2 | ||||||||
| 125829781 | 12582978 | 9 | SS | Paracetamol | ACETAMINOPHEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 125829781 | 12582978 | 10 | SS | Doxorubicin | DOXORUBICIN | 1 | Unknown | 60 MG/M2, UNK | 0 | 60 | MG/M**2 | ||||||||
| 125829781 | 12582978 | 11 | SS | Tegafur | TEGAFUR | 1 | Oral | 1200 MG/DAY | 0 | 1200 | MG | ||||||||
| 125829781 | 12582978 | 12 | SS | Oxycodone | OXYCODONE | 1 | Oral | 40MG/12HR | 0 | ||||||||||
| 125829781 | 12582978 | 13 | SS | Oxycodone | OXYCODONE | 1 | Oral | 5 MG/12HR | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125829781 | 12582978 | 1 | Pancreatic carcinoma metastatic |
| 125829781 | 12582978 | 3 | Lobular breast carcinoma in situ |
| 125829781 | 12582978 | 4 | Lobular breast carcinoma in situ |
| 125829781 | 12582978 | 5 | Lobular breast carcinoma in situ |
| 125829781 | 12582978 | 6 | Metastasis |
| 125829781 | 12582978 | 8 | Pancreatic carcinoma metastatic |
| 125829781 | 12582978 | 9 | Analgesic therapy |
| 125829781 | 12582978 | 10 | Lobular breast carcinoma in situ |
| 125829781 | 12582978 | 11 | Pancreatic carcinoma metastatic |
| 125829781 | 12582978 | 12 | Analgesic therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125829781 | 12582978 | DE |
| 125829781 | 12582978 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125829781 | 12582978 | Adenocarcinoma pancreas | |
| 125829781 | 12582978 | Biliary tract disorder | |
| 125829781 | 12582978 | Cholangitis acute | |
| 125829781 | 12582978 | Disease progression | |
| 125829781 | 12582978 | Drug intolerance | |
| 125829781 | 12582978 | Gastroenteritis radiation | |
| 125829781 | 12582978 | Hepatotoxicity | |
| 125829781 | 12582978 | Oedema peripheral | |
| 125829781 | 12582978 | Pancreatic insufficiency | |
| 125829781 | 12582978 | Treatment failure | |
| 125829781 | 12582978 | Visceral venous thrombosis |
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 |
|---|---|---|---|---|---|---|
| 125829781 | 12582978 | 2 | 201311 | 0 | ||
| 125829781 | 12582978 | 8 | 201311 | 0 |