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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121470008 | 12147000 | 8 | F | 2014 | 20160909 | 20160304 | 20160915 | EXP | CA-ABBVIE-16K-028-1571186-00 | ABBVIE | 77.59 | YR | F | Y | 0.00000 | 20160915 | MD | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121470008 | 12147000 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 60139XD08 | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||||
| 121470008 | 12147000 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 121470008 | 12147000 | 3 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Oral | 0 | |||||||||||
| 121470008 | 12147000 | 4 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Oral | 0 | 2 | DF | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121470008 | 12147000 | 1 | Ankylosing spondylitis |
| 121470008 | 12147000 | 2 | Colitis microscopic |
| 121470008 | 12147000 | 3 | Ankylosing spondylitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121470008 | 12147000 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121470008 | 12147000 | Arthralgia | |
| 121470008 | 12147000 | Cough | |
| 121470008 | 12147000 | Discomfort | |
| 121470008 | 12147000 | Dyspnoea | |
| 121470008 | 12147000 | Generalised oedema | |
| 121470008 | 12147000 | Insomnia | |
| 121470008 | 12147000 | Pain in extremity | |
| 121470008 | 12147000 | Paraesthesia | |
| 121470008 | 12147000 | Pharyngeal oedema | |
| 121470008 | 12147000 | Pleural effusion | |
| 121470008 | 12147000 | Swelling face |
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 |
|---|---|---|---|---|---|---|
| 121470008 | 12147000 | 1 | 20120807 | 0 | ||
| 121470008 | 12147000 | 4 | 201605 | 0 |