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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
5857453 | 6705154 | F | 1 | 5857453-1 | 20080401 | 20080523 | 20080818 | PER | TPA2008A00478 | TAKEDA PHARMACEUTICALS NORTH AMERICA | 51 | YR | M | N | 165 | LBS | 20080724 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|
5857453 | 1010351674 | PS | ROZEREM | 1 | ORAL | 8 MG, QHS, PER ORAL | Y | D | C13291 | 20100101 | 21782 |
5857453 | 1010460560 | C | ASACOL | 1 | |||||||
5857453 | 1010460561 | C | LYRICA | 1 |
Indications of drugs used
Event ID | DRUG SEQ | INDI PT |
---|---|---|
5857453 | 1010351674 | INSOMNIA |
Outcome of event
no results found |
Reactions reported
Event ID | PT |
---|---|
5857453 | DISCOMFORT |
5857453 | GENERAL PHYSICAL CONDITION ABNORMAL |
5857453 | INITIAL INSOMNIA |
5857453 | PALPITATIONS |
Reporting Sources (this data is often not reported and may therefore be missing here)
Event ID | RPSR COD |
---|---|
5857453 | CSM |
5857453 | HP |
Therapies reported
Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
---|---|---|---|---|---|
5857453 | 1010351674 | 20080201 | 20080403 |