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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100234891 | 10023489 | 1 | I | 20131124 | 20131204 | 20131231 | 20131231 | EXP | 2013SA126420 | SANOFI | 61.00 | YR | M | N | 0.00000 | 20131230 | N | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100234891 | 10023489 | 1 | PS | RIFAMPICIN | 1 | INTRAVENOUS | (NOT OTHERWISE SPECIFIED) | D | 50627 | 1800 | MG | QD | |||||||
| 100234891 | 10023489 | 2 | SS | LEVETIRACETAM (LEVETIRACETAM) | 1 | ORAL | D | D | 0 | 250 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100234891 | 10023489 | 1 | Product used for unknown indication |
| 100234891 | 10023489 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100234891 | 10023489 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100234891 | 10023489 | Cholestasis | |
| 100234891 | 10023489 | Hyperbilirubinaemia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 100234891 | 10023489 | HP |
| 100234891 | 10023489 | FGN |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 100234891 | 10023489 | 1 | 20131123 | 20131125 | 0 | |
| 100234891 | 10023489 | 2 | 20131107 | 0 |