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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125530711 | 12553071 | 1 | I | 20160527 | 20160701 | 20160713 | 20160713 | EXP | FR-ANSM-PA20160575 (0) | FR-LUNDBECK-DKLU2016308 | LUNDBECK | 50.00 | YR | M | Y | 0.00000 | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125530711 | 12553071 | 1 | PS | Urbanyl | CLOBAZAM | 1 | Oral | 202067 | 10 | MG | QD | ||||||||
| 125530711 | 12553071 | 2 | SS | ROVAMYCINE | SPIRAMYCIN | 1 | Unknown | U | 0 | ||||||||||
| 125530711 | 12553071 | 3 | SS | BRICANYL | TERBUTALINE SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 125530711 | 12553071 | 4 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 0 | 500 | MG | QD | ||||||||
| 125530711 | 12553071 | 5 | SS | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 125530711 | 12553071 | 6 | SS | ATROVENT | IPRATROPIUM BROMIDE | 1 | Unknown | U | 0 | ||||||||||
| 125530711 | 12553071 | 7 | SS | TAZOCILLINE | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125530711 | 12553071 | 1 | Product used for unknown indication |
| 125530711 | 12553071 | 2 | Product used for unknown indication |
| 125530711 | 12553071 | 3 | Product used for unknown indication |
| 125530711 | 12553071 | 4 | Product used for unknown indication |
| 125530711 | 12553071 | 5 | Product used for unknown indication |
| 125530711 | 12553071 | 6 | Product used for unknown indication |
| 125530711 | 12553071 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125530711 | 12553071 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125530711 | 12553071 | Acute kidney injury | |
| 125530711 | 12553071 | Cell death | |
| 125530711 | 12553071 | Cholestasis | |
| 125530711 | 12553071 | Inflammation | |
| 125530711 | 12553071 | Lactic acidosis | |
| 125530711 | 12553071 | Rhabdomyolysis |
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 |
|---|---|---|---|---|---|---|
| 125530711 | 12553071 | 2 | 20160528 | 20160530 | 0 | |
| 125530711 | 12553071 | 5 | 20160527 | 20160530 | 0 | |
| 125530711 | 12553071 | 6 | 20160528 | 0 | ||
| 125530711 | 12553071 | 7 | 20160528 | 0 |