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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126742371 | 12674237 | 1 | I | 20160801 | 20160811 | 20160822 | 20160822 | EXP | FR-SA-2016SA149316 | AVENTIS | 80.00 | YR | E | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126742371 | 12674237 | 1 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | N | UNKNOWN | 0 | 37.5 | MG | QD | ||||||
| 126742371 | 12674237 | 2 | PS | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | UNKNOWN | 20164 | ||||||||||
| 126742371 | 12674237 | 3 | SS | DIFICLIR | FIDAXOMICIN | 1 | Oral | N | UNKNOWN | 0 | FILM-COATED TABLET | ||||||||
| 126742371 | 12674237 | 4 | SS | DIFICLIR | FIDAXOMICIN | 1 | Oral | N | UNKNOWN | 0 | FILM-COATED TABLET | ||||||||
| 126742371 | 12674237 | 5 | SS | DIFICLIR | FIDAXOMICIN | 1 | Oral | N | UNKNOWN | 0 | 200 | MG | FILM-COATED TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126742371 | 12674237 | 1 | Depression |
| 126742371 | 12674237 | 2 | Thrombosis prophylaxis |
| 126742371 | 12674237 | 3 | Clostridium difficile infection |
| 126742371 | 12674237 | 4 | Clostridium difficile infection |
| 126742371 | 12674237 | 5 | Clostridium difficile infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126742371 | 12674237 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126742371 | 12674237 | Alanine aminotransferase increased | |
| 126742371 | 12674237 | Aspartate aminotransferase increased | |
| 126742371 | 12674237 | Blood alkaline phosphatase increased | |
| 126742371 | 12674237 | Gamma-glutamyltransferase increased | |
| 126742371 | 12674237 | Hepatocellular injury | |
| 126742371 | 12674237 | Prothrombin time shortened |
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 |
|---|---|---|---|---|---|---|
| 126742371 | 12674237 | 1 | 20160725 | 20160801 | 0 | |
| 126742371 | 12674237 | 2 | 20160720 | 0 | ||
| 126742371 | 12674237 | 3 | 20160713 | 20160720 | 0 | |
| 126742371 | 12674237 | 4 | 20160701 | 0 | ||
| 126742371 | 12674237 | 5 | 20160729 | 20160801 | 0 |