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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123682774 | 12368277 | 4 | F | 2016 | 20160812 | 20160513 | 20160818 | EXP | CL-ABBVIE-16K-034-1624931-00 | ABBVIE | 0.00 | F | Y | 0.00000 | 20160818 | CN | COUNTRY NOT SPECIFIED | CL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123682774 | 12368277 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 123682774 | 12368277 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 123682774 | 12368277 | 3 | C | CELEBRA | CELECOXIB | 1 | 0 | ||||||||||||
| 123682774 | 12368277 | 4 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 123682774 | 12368277 | 5 | C | TRAMAL | TRAMADOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123682774 | 12368277 | 1 | Axial spondyloarthritis |
| 123682774 | 12368277 | 3 | Product used for unknown indication |
| 123682774 | 12368277 | 4 | Product used for unknown indication |
| 123682774 | 12368277 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123682774 | 12368277 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123682774 | 12368277 | Back pain | |
| 123682774 | 12368277 | Pneumonia | |
| 123682774 | 12368277 | Pulmonary oedema |
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 |
|---|---|---|---|---|---|---|
| 123682774 | 12368277 | 1 | 20160106 | 20160420 | 0 | |
| 123682774 | 12368277 | 2 | 20160731 | 0 |