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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117872785 | 11787278 | 5 | F | 20150820 | 20160909 | 20151130 | 20160922 | EXP | CA-TAKEDA-2015TUS012330 | TAKEDA | 47.00 | YR | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117872785 | 11787278 | 1 | PS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | 343475 | 125476 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 117872785 | 11787278 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 7.5 MG, 1/WEEK | N | 0 | 7.5 | MG | /wk | ||||||
| 117872785 | 11787278 | 3 | C | PREDNISONE. | PREDNISONE | 1 | 25 MG, QD | U | 0 | 25 | MG | QD | |||||||
| 117872785 | 11787278 | 4 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0.075 MG, QD | U | 0 | .075 | MG | QD | |||||||
| 117872785 | 11787278 | 5 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 40 MG, QD | U | 0 | 40 | MG | QD | |||||||
| 117872785 | 11787278 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 MG, QD | U | 0 | 1 | MG | QD | |||||||
| 117872785 | 11787278 | 7 | C | IRON | IRON | 1 | Intravenous (not otherwise specified) | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117872785 | 11787278 | 1 | Crohn's disease |
| 117872785 | 11787278 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117872785 | 11787278 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117872785 | 11787278 | Abdominal distension | |
| 117872785 | 11787278 | Abdominal pain | |
| 117872785 | 11787278 | Diarrhoea | |
| 117872785 | 11787278 | Dizziness | |
| 117872785 | 11787278 | Dyspnoea | |
| 117872785 | 11787278 | Fatigue | |
| 117872785 | 11787278 | Gastrointestinal pain | |
| 117872785 | 11787278 | Haemoglobin decreased | |
| 117872785 | 11787278 | Headache | |
| 117872785 | 11787278 | Insomnia | |
| 117872785 | 11787278 | Nausea | |
| 117872785 | 11787278 | Off label use | |
| 117872785 | 11787278 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 117872785 | 11787278 | 1 | 20150820 | 0 | ||
| 117872785 | 11787278 | 2 | 20150601 | 0 |