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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125199442 | 12519944 | 2 | F | 2011 | 20160906 | 20160630 | 20160913 | EXP | US-ABBVIE-16K-163-1659833-00 | ABBVIE | 0.00 | M | Y | 0.00000 | 20160913 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125199442 | 12519944 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 1057363 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 125199442 | 12519944 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 1057363 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | |||||
| 125199442 | 12519944 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Y | 1057363 | 125057 | ||||||||||
| 125199442 | 12519944 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125199442 | 12519944 | 1 | Colitis ulcerative |
| 125199442 | 12519944 | 2 | Ankylosing spondylitis |
| 125199442 | 12519944 | 3 | Rheumatoid arthritis |
| 125199442 | 12519944 | 4 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125199442 | 12519944 | OT |
| 125199442 | 12519944 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125199442 | 12519944 | Arthralgia | |
| 125199442 | 12519944 | Colostomy | |
| 125199442 | 12519944 | Diabetes mellitus | |
| 125199442 | 12519944 | Drug effect decreased | |
| 125199442 | 12519944 | Ileostomy | |
| 125199442 | 12519944 | Internal haemorrhage | |
| 125199442 | 12519944 | Pancreatic insufficiency | |
| 125199442 | 12519944 | Stoma site extravasation | |
| 125199442 | 12519944 | Tachycardia | |
| 125199442 | 12519944 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125199442 | 12519944 | 1 | 2011 | 0 | ||
| 125199442 | 12519944 | 2 | 20151121 | 0 |