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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111961373 | 11196137 | 3 | F | 20150731 | 20160701 | 20150617 | 20160712 | EXP | BR-ABBVIE-15K-020-1361177-00 | ABBVIE | 48.36 | YR | M | Y | 94.00000 | KG | 20160712 | CN | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111961373 | 11196137 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 111961373 | 11196137 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 111961373 | 11196137 | 3 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 2 | DF | TABLET | BIW | |||||||
| 111961373 | 11196137 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | 4 | DF | TABLET | BIW | |||||||
| 111961373 | 11196137 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | TABLET | ||||||||||
| 111961373 | 11196137 | 6 | C | DICLOFENAC SODIUM. | DICLOFENAC SODIUM | 1 | Oral | 0 | 2 | DF | TABLET | BID | |||||||
| 111961373 | 11196137 | 7 | C | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111961373 | 11196137 | 1 | Ankylosing spondylitis |
| 111961373 | 11196137 | 3 | Product used for unknown indication |
| 111961373 | 11196137 | 4 | Ankylosing spondylitis |
| 111961373 | 11196137 | 5 | Pain |
| 111961373 | 11196137 | 6 | Pain |
| 111961373 | 11196137 | 7 | Bone disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111961373 | 11196137 | HO |
| 111961373 | 11196137 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111961373 | 11196137 | Chondropathy | |
| 111961373 | 11196137 | Limb operation | |
| 111961373 | 11196137 | Medical device pain | |
| 111961373 | 11196137 | Osteoarthritis | |
| 111961373 | 11196137 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 111961373 | 11196137 | 1 | 20141201 | 20150410 | 0 | |
| 111961373 | 11196137 | 2 | 20160612 | 0 | ||
| 111961373 | 11196137 | 3 | 2013 | 0 | ||
| 111961373 | 11196137 | 4 | 201211 | 201601 | 0 | |
| 111961373 | 11196137 | 5 | 2013 | 0 | ||
| 111961373 | 11196137 | 6 | 201211 | 0 | ||
| 111961373 | 11196137 | 7 | 201211 | 0 |