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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125397231 | 12539723 | 1 | I | 201603 | 20160324 | 20160708 | 20160708 | EXP | JP-TAKEDA-2016TJP006094 | TAKEDA | 61.00 | YR | M | Y | 0.00000 | 20160708 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125397231 | 12539723 | 1 | PS | ROZEREM | RAMELTEON | 1 | Oral | 8 MG, UNK | Y | Y | 21782 | 8 | MG | TABLET | |||||
| 125397231 | 12539723 | 2 | SS | ROZEREM | RAMELTEON | 1 | Oral | 8 MG, UNK | Y | Y | 21782 | 8 | MG | TABLET | |||||
| 125397231 | 12539723 | 3 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125397231 | 12539723 | 1 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125397231 | 12539723 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125397231 | 12539723 | Apnoea | Apnoea |
| 125397231 | 12539723 | Hypersomnia |
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 |
|---|---|---|---|---|---|---|
| 125397231 | 12539723 | 1 | 20160311 | 20160314 | 0 |