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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126481291 | 12648129 | 1 | I | 20160704 | 20160714 | 20160812 | 20160812 | EXP | GB-CELLTRION INC.-2016GB006962 | CELLTRION | 0.00 | Y | 0.00000 | 20160812 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126481291 | 12648129 | 1 | PS | Infliximab | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 120 MG, UNK | Y | U | 125544 | 120 | MG | POWDER FOR SOLUTION FOR INFUSION | |||||
| 126481291 | 12648129 | 2 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | |||||||||||
| 126481291 | 12648129 | 3 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 126481291 | 12648129 | 4 | C | CHLORPHENAMINE | CHLORPHENIRAMINE MALEATE | 1 | Intravenous (not otherwise specified) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126481291 | 12648129 | 1 | Juvenile idiopathic arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126481291 | 12648129 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126481291 | 12648129 | Anaphylactic reaction | |
| 126481291 | 12648129 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 126481291 | 12648129 | 1 | 20160704 | 20160704 | 0 |