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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119297082 | 11929708 | 2 | F | 20151123 | 20160107 | 20160120 | 20160720 | EXP | IT-MINISAL02-340443 | IT-MYLANLABS-2015M1047712 | MYLAN | 0.00 | Y | 0.00000 | 20160720 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119297082 | 11929708 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 1200 MG, UNK | Y | 90335 | 1200 | MG | |||||||
| 119297082 | 11929708 | 2 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | 200 MG | 0 | 200 | MG | ||||||||
| 119297082 | 11929708 | 3 | C | RIVOTRIL | CLONAZEPAM | 1 | Oral | 15 GTT | 0 | 15 | GTT | ORAL DROPS, SOLUTION | |||||||
| 119297082 | 11929708 | 4 | C | ALCOVER | SODIUM OXYBATE | 1 | Oral | 20 ML | 0 | 20 | ML | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119297082 | 11929708 | 1 | Bipolar disorder |
| 119297082 | 11929708 | 2 | Product used for unknown indication |
| 119297082 | 11929708 | 3 | Product used for unknown indication |
| 119297082 | 11929708 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119297082 | 11929708 | Erythema | |
| 119297082 | 11929708 | Oedema peripheral | |
| 119297082 | 11929708 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 119297082 | 11929708 | 1 | 20151123 | 20151209 | 0 | |
| 119297082 | 11929708 | 2 | 20151125 | 20151211 | 0 | |
| 119297082 | 11929708 | 3 | 20151119 | 20151211 | 0 | |
| 119297082 | 11929708 | 4 | 20151119 | 20151211 | 0 |