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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118367322 | 11836732 | 2 | F | 20151111 | 20151211 | 20151215 | 20160101 | PER | US-TAKEDA-2015TUS017615 | TAKEDA | 40.13 | YR | F | Y | 62.13000 | KG | 20160101 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118367322 | 11836732 | 1 | PS | ENTYVIO | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | C22334 | 125476 | 300 | MG | INFUSION | ||||||
| 118367322 | 11836732 | 2 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | UNK | U | 0 | |||||||||
| 118367322 | 11836732 | 3 | C | METHOTREXATE | METHOTREXATE | 1 | UNK | U | 0 | ||||||||||
| 118367322 | 11836732 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Oral | UNK | U | 0 | |||||||||
| 118367322 | 11836732 | 5 | C | IRON | IRON | 1 | UNK | U | 0 | INFUSION | |||||||||
| 118367322 | 11836732 | 6 | C | POTASSIUM | POTASSIUM | 1 | UNK | U | 0 | INFUSION | |||||||||
| 118367322 | 11836732 | 7 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | UNK | U | 0 | |||||||||
| 118367322 | 11836732 | 8 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | UNK | U | 0 | |||||||||
| 118367322 | 11836732 | 9 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | UNK | U | 0 | |||||||||
| 118367322 | 11836732 | 10 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | UNK | U | 0 | |||||||||
| 118367322 | 11836732 | 11 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | UNK | U | 0 | |||||||||
| 118367322 | 11836732 | 12 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Other | UNK | U | 0 | |||||||||
| 118367322 | 11836732 | 13 | C | LEVSIN | HYOSCYAMINE SULFATE | 1 | Oral | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118367322 | 11836732 | 1 | Crohn's disease |
| 118367322 | 11836732 | 2 | Hypothyroidism |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118367322 | 11836732 | Influenza like illness |
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 |
|---|---|---|---|---|---|---|
| 118367322 | 11836732 | 1 | 20151111 | 0 |