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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122761845 | 12276184 | 5 | F | 20160127 | 20160823 | 20160418 | 20160902 | EXP | FR-TAKEDA-2016TUS006291 | TAKEDA | 20.00 | YR | F | Y | 0.00000 | 20160902 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122761845 | 12276184 | 1 | PS | ENTYVIO | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | Y | 125476 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 122761845 | 12276184 | 2 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 500 MG, QD | 3000 | MG | Y | 0 | 500 | MG | QD | ||||
| 122761845 | 12276184 | 3 | SS | TOPLEXIL | UNSPECIFIED INGREDIENT | 1 | Oral | UNK | Y | 0 | |||||||||
| 122761845 | 12276184 | 4 | C | CEFUROXIME. | CEFUROXIME | 1 | UNK | U | 0 | ||||||||||
| 122761845 | 12276184 | 5 | C | ENTOCORT | BUDESONIDE | 1 | Oral | UNK, BID | U | 0 | BID | ||||||||
| 122761845 | 12276184 | 6 | C | VOGALENE | METOPIMAZINE | 1 | UNK | U | 0 | ||||||||||
| 122761845 | 12276184 | 7 | C | HELICIDINE | ESCARGOT | 1 | UNK | U | 0 | ||||||||||
| 122761845 | 12276184 | 8 | C | AERIUS | DESLORATADINE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122761845 | 12276184 | 1 | Crohn's disease |
| 122761845 | 12276184 | 2 | Respiratory tract infection |
| 122761845 | 12276184 | 3 | Cough |
| 122761845 | 12276184 | 4 | Respiratory tract infection |
| 122761845 | 12276184 | 5 | Product used for unknown indication |
| 122761845 | 12276184 | 6 | Product used for unknown indication |
| 122761845 | 12276184 | 7 | Product used for unknown indication |
| 122761845 | 12276184 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122761845 | 12276184 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122761845 | 12276184 | Abasia | |
| 122761845 | 12276184 | Dystonia | |
| 122761845 | 12276184 | Facial paralysis | |
| 122761845 | 12276184 | Muscular weakness | |
| 122761845 | 12276184 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 122761845 | 12276184 | 1 | 20151216 | 20160127 | 0 | |
| 122761845 | 12276184 | 2 | 20160122 | 20160131 | 0 | |
| 122761845 | 12276184 | 3 | 20160122 | 0 | ||
| 122761845 | 12276184 | 4 | 20160119 | 20160122 | 0 | |
| 122761845 | 12276184 | 6 | 20160119 | 0 |