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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118436955 | 11843695 | 5 | F | 20150325 | 20160126 | 20151217 | 20160210 | EXP | 337405 | IT-ACCORD-036190 | ACCORD | 56.00 | YR | M | Y | 67.00000 | KG | 20160208 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118436955 | 11843695 | 1 | PS | GEMCITABINE/GEMCITABINE HYDROCHLORIDE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | GEMOX CYCLE ALSO USED IN ABRA GEM CYCLE GEMOX CYCLE 2: 24-MAR-2015 TO 20-MAY-2015 | 91594 | 1500 | MG | SOLUTION FOR INFUSION | |||||||
| 118436955 | 11843695 | 2 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | GEMOX CYCLE 1 (EVERY 14 DAYS) AND CYCLE 2 | 200750096 | 150 | MG | SOLUTION FOR INFUSION | |||||||
| 118436955 | 11843695 | 3 | SS | ABRAXANE | PACLITAXEL | 1 | Intravenous (not otherwise specified) | (PACLITAXEL ALBUMIN); ABRA/GEM (DAY 1-8-15) EVERY 28 DAYS | 0 | 200 | MG | SOLUTION FOR INFUSION | |||||||
| 118436955 | 11843695 | 4 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Oral | STRENGTH: 10000 PH.EUR UNITS | 0 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | |||||||
| 118436955 | 11843695 | 5 | C | CONGESCOR | BISOPROLOL | 1 | Oral | 1.25 MG | 0 | 1.25 | MG | ||||||||
| 118436955 | 11843695 | 6 | C | LORTAAN | LOSARTAN POTASSIUM | 1 | Oral | STRENGTH: 50 MG | 0 | 50 | MG | FILM-COATED TABLET | |||||||
| 118436955 | 11843695 | 7 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | STRENGTH: 4000 U.I. AXA/0.4 ML | 0 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 118436955 | 11843695 | 8 | C | INSULIN | INSULIN NOS | 1 | Subcutaneous | 0 | |||||||||||
| 118436955 | 11843695 | 9 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 30 MG | 0 | 30 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118436955 | 11843695 | 1 | Pancreatic carcinoma metastatic |
| 118436955 | 11843695 | 2 | Pancreatic carcinoma metastatic |
| 118436955 | 11843695 | 3 | Pancreatic carcinoma metastatic |
| 118436955 | 11843695 | 5 | Hypertension |
| 118436955 | 11843695 | 6 | Hypertension |
| 118436955 | 11843695 | 8 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118436955 | 11843695 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118436955 | 11843695 | Anaemia | |
| 118436955 | 11843695 | Constipation | |
| 118436955 | 11843695 | Diarrhoea | |
| 118436955 | 11843695 | Flatulence | |
| 118436955 | 11843695 | Neutropenia | |
| 118436955 | 11843695 | Off label use | |
| 118436955 | 11843695 | Paraesthesia | |
| 118436955 | 11843695 | Thrombocytosis |
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 |
|---|---|---|---|---|---|---|
| 118436955 | 11843695 | 1 | 20150324 | 0 | ||
| 118436955 | 11843695 | 2 | 20150324 | 0 | ||
| 118436955 | 11843695 | 3 | 20150624 | 0 |