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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126085431 | 12608543 | 1 | I | 20150707 | 20150719 | 20160729 | 20160729 | EXP | CA-TAKEDA-2015TUS009432 | TAKEDA | 37.00 | YR | F | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126085431 | 12608543 | 1 | PS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | 125476 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | |||||||
| 126085431 | 12608543 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 25 MG, QD | Y | U | 0 | 25 | MG | QD | |||||
| 126085431 | 12608543 | 3 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126085431 | 12608543 | 4 | C | FENTANYL. | FENTANYL | 1 | Unknown | UNK | U | 0 | PATCH | ||||||||
| 126085431 | 12608543 | 5 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126085431 | 12608543 | 6 | C | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126085431 | 12608543 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 15 MG, 1/WEEK | U | 0 | 15 | MG | /wk | ||||||
| 126085431 | 12608543 | 8 | C | SEPTRA DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK UNK, 3/WEEK | U | 0 | TABLET | TIW | |||||||
| 126085431 | 12608543 | 9 | C | IRON | IRON | 1 | UNK UNK, BID | U | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126085431 | 12608543 | 1 | Crohn's disease |
| 126085431 | 12608543 | 2 | Product used for unknown indication |
| 126085431 | 12608543 | 9 | Anaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126085431 | 12608543 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126085431 | 12608543 | Blood cortisol decreased | |
| 126085431 | 12608543 | Fatigue | |
| 126085431 | 12608543 | Hypoaesthesia | |
| 126085431 | 12608543 | Memory impairment | |
| 126085431 | 12608543 | Nausea | |
| 126085431 | 12608543 | Off label use | |
| 126085431 | 12608543 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126085431 | 12608543 | 1 | 20150707 | 0 | ||
| 126085431 | 12608543 | 9 | 2015 | 0 |