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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121831953 | 12183195 | 3 | F | 20160229 | 20160712 | 20160316 | 20160714 | EXP | JP-009507513-1603JPN006267 | MERCK | 66.00 | YR | M | Y | 87.00000 | KG | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121831953 | 12183195 | 1 | PS | BELSOMRA | SUVOREXANT | 1 | Oral | 1 DOSAGE FORM, QD | 2 | DF | Y | 204569 | 1 | DF | TABLET | QD | |||
| 121831953 | 12183195 | 2 | SS | ROZEREM | RAMELTEON | 1 | Oral | 1 DOSAGE FORM, QD | 1 | DF | Y | 0 | 1 | DF | TABLET | QD | |||
| 121831953 | 12183195 | 3 | C | HOKUNALIN | TULOBUTEROL | 1 | Transdermal | 1 DOSEAGE FORM, QD | 3 | DF | U | 0 | 1 | DF | TRANSDERMAL PATCH | QD | |||
| 121831953 | 12183195 | 4 | C | MIYA-BM | CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 | 1 | Oral | 2 DOSAGE FORM, TID | 24 | DF | U | 0 | 2 | DF | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121831953 | 12183195 | 1 | Insomnia |
| 121831953 | 12183195 | 2 | Insomnia |
| 121831953 | 12183195 | 3 | Hypertension |
| 121831953 | 12183195 | 4 | Enterocolitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121831953 | 12183195 | HO |
| 121831953 | 12183195 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121831953 | 12183195 | Altered state of consciousness |
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 |
|---|---|---|---|---|---|---|
| 121831953 | 12183195 | 1 | 20160227 | 20160228 | 0 | |
| 121831953 | 12183195 | 2 | 20160228 | 20160228 | 0 | |
| 121831953 | 12183195 | 3 | 20160226 | 20160228 | 0 | |
| 121831953 | 12183195 | 4 | 20160226 | 20160322 | 0 |