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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126706391 | 12670639 | 1 | I | 20160801 | 20160812 | 20160822 | 20160822 | EXP | FR-009507513-1608FRA007710 | MERCK | 80.51 | YR | M | Y | 0.00000 | 20160822 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126706391 | 12670639 | 1 | PS | FIDAXOMICIN | FIDAXOMICIN | 1 | Oral | UNK | 1600 | MG | N | 201699 | TABLET | ||||||
| 126706391 | 12670639 | 2 | SS | FIDAXOMICIN | FIDAXOMICIN | 1 | Oral | 200 MG 2/DAY | 1600 | MG | N | 201699 | 200 | MG | TABLET | BID | |||
| 126706391 | 12670639 | 3 | SS | VENLAFAXINE HYDROCHLORIDE. | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 37.5 MG/ DAY | 300 | MG | N | 0 | 37.5 | MG | QD | ||||
| 126706391 | 12670639 | 4 | SS | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 126706391 | 12670639 | 5 | C | HUMULIN NOS | INSULIN HUMAN | 1 | 10 U IN THE MORNING AND 4 U IN THE EVENING | 0 | BID | ||||||||||
| 126706391 | 12670639 | 6 | C | PARIET | RABEPRAZOLE SODIUM | 1 | 20 MG/ DAY | 0 | 20 | MG | QD | ||||||||
| 126706391 | 12670639 | 7 | C | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | 25 MG 2/DAY | 0 | 25 | MG | BID | ||||||||
| 126706391 | 12670639 | 8 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | 1 MG 2/DAY | 0 | 1 | MG | BID | ||||||||
| 126706391 | 12670639 | 9 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126706391 | 12670639 | 1 | Clostridium difficile infection |
| 126706391 | 12670639 | 3 | Depression |
| 126706391 | 12670639 | 4 | Thrombosis prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126706391 | 12670639 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126706391 | 12670639 | Alanine aminotransferase increased | |
| 126706391 | 12670639 | Aspartate aminotransferase increased | |
| 126706391 | 12670639 | Blood alkaline phosphatase increased | |
| 126706391 | 12670639 | Gamma-glutamyltransferase increased | |
| 126706391 | 12670639 | Hepatocellular injury | |
| 126706391 | 12670639 | 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 |
|---|---|---|---|---|---|---|
| 126706391 | 12670639 | 1 | 20160713 | 20160720 | 0 | |
| 126706391 | 12670639 | 2 | 20160729 | 20160801 | 0 | |
| 126706391 | 12670639 | 3 | 20160725 | 20160801 | 0 | |
| 126706391 | 12670639 | 4 | 20160720 | 0 | ||
| 126706391 | 12670639 | 7 | 20160801 | 0 | ||
| 126706391 | 12670639 | 9 | 20160801 | 0 |