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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126852981 | 12685298 | 1 | I | 20121129 | 20160815 | 20160825 | 20160825 | EXP | US-MEDA-2016080060 | MEDA | 80.00 | YR | E | F | Y | 61.00000 | KG | 20160825 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126852981 | 12685298 | 1 | PS | SOMA | CARISOPRODOL | 1 | Oral | Y | 11792 | 175 | MG | ||||||||
| 126852981 | 12685298 | 2 | SS | hESC-RPE | INVESTIGATIONAL PRODUCT | 1 | Intraocular | 100000 CELLS TOTAL | Y | 0 | INJECTION | ||||||||
| 126852981 | 12685298 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Y | 0 | |||||||||||
| 126852981 | 12685298 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Y | 0 | |||||||||||
| 126852981 | 12685298 | 5 | C | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | 0 | ||||||||||||
| 126852981 | 12685298 | 6 | C | IRON | IRON | 1 | 0 | ||||||||||||
| 126852981 | 12685298 | 7 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0 | ||||||||||||
| 126852981 | 12685298 | 8 | C | OCUVITE | VITAMINS | 1 | 0 | ||||||||||||
| 126852981 | 12685298 | 9 | C | VITAMIN B COMPLEX PLUS | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126852981 | 12685298 | 1 | Back pain |
| 126852981 | 12685298 | 2 | Dry age-related macular degeneration |
| 126852981 | 12685298 | 3 | Immunosuppression |
| 126852981 | 12685298 | 4 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126852981 | 12685298 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126852981 | 12685298 | Mental status changes | |
| 126852981 | 12685298 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 126852981 | 12685298 | 1 | 20121128 | 20121128 | 0 | |
| 126852981 | 12685298 | 2 | 20121127 | 20121127 | 0 | |
| 126852981 | 12685298 | 3 | 20121120 | 20121130 | 0 | |
| 126852981 | 12685298 | 4 | 20121120 | 20121201 | 0 |