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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126621981 | 12662198 | 1 | I | 20160215 | 20160808 | 20160817 | 20160817 | EXP | DE-ABBVIE-16K-062-1698737-00 | ABBVIE | 64.00 | YR | F | Y | 0.00000 | 20160817 | MD | COUNTRY NOT SPECIFIED | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126621981 | 12662198 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION | |||||||
| 126621981 | 12662198 | 2 | SS | MTX | METHOTREXATE SODIUM | 1 | Unknown | UNKNOWN | 0 | 7.5 | MG | ||||||||
| 126621981 | 12662198 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNKNOWN | 0 | 2000 | MG | ||||||||
| 126621981 | 12662198 | 4 | SS | MABTHERA | RITUXIMAB | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 126621981 | 12662198 | 5 | C | LEFLUNOMID | LEFLUNOMIDE | 1 | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126621981 | 12662198 | 1 | Rheumatoid arthritis |
| 126621981 | 12662198 | 2 | Product used for unknown indication |
| 126621981 | 12662198 | 3 | Product used for unknown indication |
| 126621981 | 12662198 | 4 | Product used for unknown indication |
| 126621981 | 12662198 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126621981 | 12662198 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126621981 | 12662198 | Cold sweat | |
| 126621981 | 12662198 | Headache | |
| 126621981 | 12662198 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 126621981 | 12662198 | 1 | 201412 | 201503 | 0 | |
| 126621981 | 12662198 | 2 | 2013 | 0 | ||
| 126621981 | 12662198 | 3 | 2013 | 0 | ||
| 126621981 | 12662198 | 5 | 2015 | 0 |