Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5465115 | 6437270 | I | 5465115-8 | 20070630 | 20070702 | 20070820 | PER | TPA2007A01410 | TAKEDA PHARMACEUTICALS NORTH AMERICA. | 76 | YR | F | N | 116 | LBS | 20070813 | CN | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5465115 | 1008963318 | PS | ROZEREM | 1 | ORAL | 8 MG, HS, PER ORAL | Y | D | 21782 | ||
| 5465115 | 1009014834 | C | VYTORIN | 1 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5465115 | 1008963318 | INSOMNIA |
Outcome of event
| no results found |
Reactions reported
| Event ID | PT |
|---|---|
| 5465115 | INITIAL INSOMNIA |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 5465115 | CSM |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5465115 | 1008963318 | 20070630 | 20070701 |