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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125581911 | 12558191 | 1 | I | 201602 | 20160712 | 20160714 | 20160714 | EXP | FR-AFSSAPS-RE20160666 | FR-GLAXOSMITHKLINE-FR2016GSK100550 | GLAXOSMITHKLINE | 58.00 | YR | M | Y | 63.00000 | KG | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125581911 | 12558191 | 1 | PS | KIVEXA | ABACAVIR SULFATELAMIVUDINE | 1 | Oral | UNK UNK, QD | 21652 | FILM-COATED TABLET | QD | ||||||||
| 125581911 | 12558191 | 2 | SS | TAHOR | ATORVASTATIN CALCIUM | 1 | Oral | 10 MG, 1D | Y | 0 | 10 | MG | TABLET | QD | |||||
| 125581911 | 12558191 | 3 | SS | DIAZEPAM. | DIAZEPAM | 1 | Oral | 10 G, TID | Y | 0 | 10 | G | TID | ||||||
| 125581911 | 12558191 | 4 | SS | BACLOFENE | BACLOFEN | 1 | Oral | 10 MG, BID | Y | 0 | 10 | MG | BID | ||||||
| 125581911 | 12558191 | 5 | SS | NORVIR | RITONAVIR | 1 | Oral | 100 MG, BID | 0 | 100 | MG | BID | |||||||
| 125581911 | 12558191 | 6 | SS | PREZISTA | DARUNAVIR ETHANOLATE | 1 | Oral | 600 MG, BID | 0 | 600 | MG | FILM-COATED TABLET | BID | ||||||
| 125581911 | 12558191 | 7 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 500 MG, BID | Y | 0 | 500 | MG | BID | ||||||
| 125581911 | 12558191 | 8 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Oral | 200 MG, BID | 0 | 200 | MG | PROLONGED-RELEASE TABLET | BID | ||||||
| 125581911 | 12558191 | 9 | SS | PERINDOPRIL | PERINDOPRIL | 1 | Oral | 2 MG, QD | 0 | 2 | MG | QD | |||||||
| 125581911 | 12558191 | 10 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | UNK | Y | 0 | |||||||||
| 125581911 | 12558191 | 11 | C | Uvedose | CHOLECALCIFEROL | 1 | Oral | UNK | 0 | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125581911 | 12558191 | 1 | Product used for unknown indication |
| 125581911 | 12558191 | 2 | Product used for unknown indication |
| 125581911 | 12558191 | 3 | Product used for unknown indication |
| 125581911 | 12558191 | 4 | Product used for unknown indication |
| 125581911 | 12558191 | 5 | Product used for unknown indication |
| 125581911 | 12558191 | 6 | Product used for unknown indication |
| 125581911 | 12558191 | 7 | Product used for unknown indication |
| 125581911 | 12558191 | 8 | Product used for unknown indication |
| 125581911 | 12558191 | 9 | Product used for unknown indication |
| 125581911 | 12558191 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125581911 | 12558191 | OT |
| 125581911 | 12558191 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125581911 | 12558191 | Cholestasis | |
| 125581911 | 12558191 | 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 |
|---|---|---|---|---|---|---|
| 125581911 | 12558191 | 2 | 20160226 | 0 | ||
| 125581911 | 12558191 | 3 | 20160226 | 0 | ||
| 125581911 | 12558191 | 4 | 20160217 | 0 | ||
| 125581911 | 12558191 | 10 | 20160209 | 0 |