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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125842031 | 12584203 | 1 | I | 20160624 | 20160411 | 20160722 | 20160722 | EXP | CA-TAKEDA-2016TUS006411 | TAKEDA | 54.00 | YR | F | Y | 0.00000 | 20160722 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125842031 | 12584203 | 1 | PS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | 125476 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | |||||||
| 125842031 | 12584203 | 2 | SS | Atorvastatin | ATORVASTATIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125842031 | 12584203 | 3 | C | CARBAZOLE | 2 | UNK | U | 0 | |||||||||||
| 125842031 | 12584203 | 4 | C | ASA | ASPIRIN | 1 | UNK | U | 0 | ||||||||||
| 125842031 | 12584203 | 5 | C | SALOFALK /00000301/ | MESALAMINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125842031 | 12584203 | 6 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | UNK | U | 0 | ||||||||||
| 125842031 | 12584203 | 7 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | U | 0 | ||||||||||
| 125842031 | 12584203 | 8 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125842031 | 12584203 | 1 | Colitis ulcerative |
| 125842031 | 12584203 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125842031 | 12584203 | OT |
| 125842031 | 12584203 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125842031 | 12584203 | Infusion related reaction | |
| 125842031 | 12584203 | Meniscus injury | |
| 125842031 | 12584203 | Muscle spasms | |
| 125842031 | 12584203 | Pain in extremity | |
| 125842031 | 12584203 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 125842031 | 12584203 | 1 | 20150624 | 0 | ||
| 125842031 | 12584203 | 2 | 2016 | 0 |