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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125664901 | 12566490 | 1 | I | 201602 | 20160712 | 20160718 | 20160718 | EXP | FR-UCBSA-2016026342 | UCB | 58.00 | YR | M | Y | 63.00000 | KG | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125664901 | 12566490 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | UNK | Y | U | 21035 | ||||||||
| 125664901 | 12566490 | 2 | SS | TAHOR | ATORVASTATIN CALCIUM | 1 | Oral | 10 MG, ONCE DAILY (QD) | Y | U | 0 | 10 | MG | COATED TABLET | QD | ||||
| 125664901 | 12566490 | 3 | SS | DIAZEPAM. | DIAZEPAM | 1 | Oral | 10 MG, 3X/DAY (TID) | Y | U | 0 | 10 | MG | TID | |||||
| 125664901 | 12566490 | 4 | SS | BACLOFEN. | BACLOFEN | 1 | Oral | 10 MG, 2X/DAY (BID) | Y | U | 0 | 10 | MG | BID | |||||
| 125664901 | 12566490 | 5 | SS | NORVIR | RITONAVIR | 1 | Oral | 100 MG, 2X/DAY (BID) | 0 | 100 | MG | BID | |||||||
| 125664901 | 12566490 | 6 | SS | KIVEXA | ABACAVIR SULFATELAMIVUDINE | 1 | Oral | 1 DF, ONCE DAILY (QD), 600 MG/300 MG | 0 | 1 | DF | COATED TABLET | QD | ||||||
| 125664901 | 12566490 | 7 | SS | PREZISTA | DARUNAVIR ETHANOLATE | 1 | Oral | 600 MG, 2X/DAY (BID) | 0 | 600 | MG | COATED TABLET | BID | ||||||
| 125664901 | 12566490 | 8 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Oral | 200 MG, 2X/DAY (BID) | 0 | 200 | MG | BID | |||||||
| 125664901 | 12566490 | 9 | SS | Perindopril | PERINDOPRIL | 1 | Oral | 2 MG, ONCE DAILY (QD) | 0 | 2 | MG | QD | |||||||
| 125664901 | 12566490 | 10 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | UNK | Y | U | 0 | ||||||||
| 125664901 | 12566490 | 11 | C | Uvedose | CHOLECALCIFEROL | 1 | Oral | 100000 IU, EV 2 MONTHS | U | U | 0 | 100000 | IU | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125664901 | 12566490 | 1 | Product used for unknown indication |
| 125664901 | 12566490 | 2 | Product used for unknown indication |
| 125664901 | 12566490 | 3 | Product used for unknown indication |
| 125664901 | 12566490 | 4 | Product used for unknown indication |
| 125664901 | 12566490 | 5 | Product used for unknown indication |
| 125664901 | 12566490 | 6 | Product used for unknown indication |
| 125664901 | 12566490 | 7 | Product used for unknown indication |
| 125664901 | 12566490 | 8 | Product used for unknown indication |
| 125664901 | 12566490 | 9 | Product used for unknown indication |
| 125664901 | 12566490 | 10 | Product used for unknown indication |
| 125664901 | 12566490 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125664901 | 12566490 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125664901 | 12566490 | Cholestasis | |
| 125664901 | 12566490 | 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 |
|---|---|---|---|---|---|---|
| 125664901 | 12566490 | 2 | 20160226 | 0 | ||
| 125664901 | 12566490 | 3 | 20160226 | 0 | ||
| 125664901 | 12566490 | 4 | 20160217 | 201602 | 0 | |
| 125664901 | 12566490 | 10 | 20160209 | 0 |