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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115609079 | 11560907 | 9 | F | 201409 | 20160922 | 20150928 | 20160928 | EXP | CA-ABBVIE-14K-028-1301511-00 | ABBVIE | 28.32 | YR | F | Y | 72.64000 | KG | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115609079 | 11560907 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 6046438,6047099,6047688,6048704,470 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 115609079 | 11560907 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 6046438,6047099,6047688,6048704,470 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | |||||
| 115609079 | 11560907 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 6046438,6047099,6047688,6048704,470 | 125057 | SOLUTION FOR INJECTION | ||||||||
| 115609079 | 11560907 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 6046438,6047099,6047688,6048704,470 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 115609079 | 11560907 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | 47038SP03,46029SP01,47038SP04 | 125057 | SOLUTION FOR INJECTION | /wk | ||||||
| 115609079 | 11560907 | 6 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | 47038SP03,46029SP01,47038SP04 | 125057 | SOLUTION FOR INJECTION | |||||||
| 115609079 | 11560907 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115609079 | 11560907 | 1 | Crohn's disease |
| 115609079 | 11560907 | 5 | Crohn's disease |
| 115609079 | 11560907 | 7 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115609079 | 11560907 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115609079 | 11560907 | Abdominal distension | |
| 115609079 | 11560907 | Abdominal pain | |
| 115609079 | 11560907 | Anal incontinence | |
| 115609079 | 11560907 | Asthenia | |
| 115609079 | 11560907 | Blister | |
| 115609079 | 11560907 | Crohn's disease | |
| 115609079 | 11560907 | Diarrhoea | |
| 115609079 | 11560907 | Diarrhoea haemorrhagic | |
| 115609079 | 11560907 | Drug ineffective | |
| 115609079 | 11560907 | Fatigue | |
| 115609079 | 11560907 | Fistula | |
| 115609079 | 11560907 | Fistula of small intestine | |
| 115609079 | 11560907 | Frequent bowel movements | |
| 115609079 | 11560907 | Gastrointestinal infection | |
| 115609079 | 11560907 | Gastrointestinal pain | |
| 115609079 | 11560907 | Haematochezia | |
| 115609079 | 11560907 | Inflammation | |
| 115609079 | 11560907 | Infrequent bowel movements | |
| 115609079 | 11560907 | Muscle spasms | |
| 115609079 | 11560907 | Myalgia | |
| 115609079 | 11560907 | Pruritus | |
| 115609079 | 11560907 | Rash | |
| 115609079 | 11560907 | Stress | |
| 115609079 | 11560907 | Thrombosis | |
| 115609079 | 11560907 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 115609079 | 11560907 | 1 | 2013 | 0 | ||
| 115609079 | 11560907 | 2 | 2013 | 2015 | 0 | |
| 115609079 | 11560907 | 3 | 2016 | 0 | ||
| 115609079 | 11560907 | 4 | 2016 | 0 | ||
| 115609079 | 11560907 | 5 | 2015 | 0 | ||
| 115609079 | 11560907 | 6 | 20150924 | 0 |