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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113287774 | 11328777 | 4 | F | 2014 | 20160816 | 20150731 | 20160822 | EXP | CA-ABBVIE-15K-028-1434488-00 | ABBVIE | 0.00 | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113287774 | 11328777 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 113287774 | 11328777 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 113287774 | 11328777 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113287774 | 11328777 | 1 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113287774 | 11328777 | HO |
| 113287774 | 11328777 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113287774 | 11328777 | Abdominal distension | |
| 113287774 | 11328777 | Arthralgia | |
| 113287774 | 11328777 | Crohn's disease | |
| 113287774 | 11328777 | Drug effect decreased | |
| 113287774 | 11328777 | Dyspnoea | |
| 113287774 | 11328777 | Intestinal stenosis | |
| 113287774 | 11328777 | Joint swelling | |
| 113287774 | 11328777 | Mobility decreased | |
| 113287774 | 11328777 | Muscle fatigue | |
| 113287774 | 11328777 | Muscle spasms | |
| 113287774 | 11328777 | Oedema | |
| 113287774 | 11328777 | Pollakiuria | |
| 113287774 | 11328777 | Swelling | |
| 113287774 | 11328777 | Unevaluable event | |
| 113287774 | 11328777 | Vitello-intestinal duct remnant | |
| 113287774 | 11328777 | Weight decreased | |
| 113287774 | 11328777 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 113287774 | 11328777 | 1 | 20140508 | 2015 | 0 | |
| 113287774 | 11328777 | 2 | 2015 | 0 |