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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124197552 | 12419755 | 2 | F | 20160721 | 20160531 | 20160729 | EXP | BR-ABBVIE-16P-020-1639460-00 | ABBVIE | 0.00 | F | Y | 80.00000 | KG | 20160729 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124197552 | 12419755 | 1 | PS | DEPAKENE | VALPROIC ACID | 1 | Unknown | 5 CAPSULES DAILY;2 CAPSULES IN THE MORNING AND 3 CAPSULES AT NIGHT | U | UNKNOWN | 18081 | BID | |||||||
| 124197552 | 12419755 | 2 | SS | DEPAKENE | VALPROIC ACID | 1 | Unknown | U | UNKNOWN | 18081 | |||||||||
| 124197552 | 12419755 | 3 | SS | CLOZAPINE. | CLOZAPINE | 1 | Oral | 3 TABLETS AND A HALF PER DAY | N | UNKNOWN | 0 | ||||||||
| 124197552 | 12419755 | 4 | SS | CLOZAPINE. | CLOZAPINE | 1 | Unknown | N | UNKNOWN | 0 | |||||||||
| 124197552 | 12419755 | 5 | C | GLIFAGE | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 124197552 | 12419755 | 6 | C | ASACOL | MESALAMINE | 1 | 0 | ||||||||||||
| 124197552 | 12419755 | 7 | C | LIPLESS | CIPROFIBRATE | 1 | 0 | 1 | DF | ||||||||||
| 124197552 | 12419755 | 8 | C | QUETIAPINE. | QUETIAPINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124197552 | 12419755 | 1 | Bipolar disorder |
| 124197552 | 12419755 | 2 | Mood altered |
| 124197552 | 12419755 | 3 | Schizophrenia |
| 124197552 | 12419755 | 5 | Diabetes mellitus |
| 124197552 | 12419755 | 6 | Diabetes mellitus |
| 124197552 | 12419755 | 7 | Diabetes mellitus |
| 124197552 | 12419755 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124197552 | 12419755 | OT |
| 124197552 | 12419755 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124197552 | 12419755 | Hospitalisation | |
| 124197552 | 12419755 | Off label use | |
| 124197552 | 12419755 | Pleural effusion | |
| 124197552 | 12419755 | Product use issue | |
| 124197552 | 12419755 | Respiratory disorder |
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 |
|---|---|---|---|---|---|---|
| 124197552 | 12419755 | 1 | 201410 | 0 | ||
| 124197552 | 12419755 | 3 | 201501 | 0 |