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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125791211 | 12579121 | 1 | I | 201602 | 20160712 | 20160721 | 20160721 | EXP | FR-JNJFOC-20160709320 | JANSSEN | 58.00 | YR | A | M | Y | 63.00000 | KG | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125791211 | 12579121 | 1 | PS | PREZISTA | DARUNAVIR ETHANOLATE | 1 | Oral | N | 21976 | 600 | MG | TABLETS | BID | ||||||
| 125791211 | 12579121 | 2 | SS | TAHOR | ATORVASTATIN CALCIUM | 1 | Oral | IN THE EVENING | Y | 0 | 10 | MG | TABLETS | QD | |||||
| 125791211 | 12579121 | 3 | SS | DIAZEPAM. | DIAZEPAM | 1 | Oral | Y | 0 | 10 | MG | UNSPECIFIED | TID | ||||||
| 125791211 | 12579121 | 4 | SS | BACLOFENE | BACLOFEN | 1 | Oral | Y | 0 | 10 | MG | UNSPECIFIED | BID | ||||||
| 125791211 | 12579121 | 5 | SS | NORVIR | RITONAVIR | 1 | Oral | 1 MORNING AND EVENING | 0 | 100 | MG | UNSPECIFIED | BID | ||||||
| 125791211 | 12579121 | 6 | SS | KIVEXA | ABACAVIR SULFATELAMIVUDINE | 1 | Oral | 0 | 1 | DF | TABLETS | QD | |||||||
| 125791211 | 12579121 | 7 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 125791211 | 12579121 | 8 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 500 MG 1 MORNING AND EVENING | Y | 0 | 500 | MG | UNSPECIFIED | BID | |||||
| 125791211 | 12579121 | 9 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Oral | MORNING AND EVENING | 0 | 200 | MG | UNSPECIFIED | BID | ||||||
| 125791211 | 12579121 | 10 | SS | PERINDOPRIL | PERINDOPRIL | 1 | Oral | IN THE MORNING | 0 | 2 | MG | UNSPECIFIED | QD | ||||||
| 125791211 | 12579121 | 11 | SS | METFORMINE | METFORMIN HYDROCHLORIDE | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 125791211 | 12579121 | 12 | C | UVEDOSE | CHOLECALCIFEROL | 1 | Oral | 0 | 100000 | IU | SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125791211 | 12579121 | 1 | Product used for unknown indication |
| 125791211 | 12579121 | 2 | Product used for unknown indication |
| 125791211 | 12579121 | 3 | Product used for unknown indication |
| 125791211 | 12579121 | 4 | Product used for unknown indication |
| 125791211 | 12579121 | 5 | Product used for unknown indication |
| 125791211 | 12579121 | 6 | Product used for unknown indication |
| 125791211 | 12579121 | 7 | Product used for unknown indication |
| 125791211 | 12579121 | 8 | Product used for unknown indication |
| 125791211 | 12579121 | 9 | Product used for unknown indication |
| 125791211 | 12579121 | 10 | Product used for unknown indication |
| 125791211 | 12579121 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125791211 | 12579121 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125791211 | 12579121 | Cholestasis | |
| 125791211 | 12579121 | Hepatocellular injury |
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 |
|---|---|---|---|---|---|---|
| 125791211 | 12579121 | 2 | 20160226 | 0 | ||
| 125791211 | 12579121 | 3 | 20160226 | 0 | ||
| 125791211 | 12579121 | 4 | 20160217 | 0 | ||
| 125791211 | 12579121 | 11 | 20160209 | 0 | ||
| 125791211 | 12579121 | 12 | 20160209 | 0 |