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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111831046 | 11183104 | 6 | F | 2014 | 20160725 | 20150611 | 20160802 | EXP | CA-ABBVIE-15K-028-1404031-00 | ABBVIE | 0.00 | F | Y | 127.12000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111831046 | 11183104 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | 6060574 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||
| 111831046 | 11183104 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | 6060574 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||
| 111831046 | 11183104 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | N | 6060574 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||
| 111831046 | 11183104 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | UNKNOWN | 0 | |||||||||
| 111831046 | 11183104 | 5 | SS | PENICILLIN NOS | PENICILLIN | 1 | Oral | UNKNOWN | 0 | ||||||||||
| 111831046 | 11183104 | 6 | SS | SERC | BETAHISTINE HYDROCHLORIDE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 111831046 | 11183104 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 111831046 | 11183104 | 8 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111831046 | 11183104 | 1 | Crohn's disease |
| 111831046 | 11183104 | 4 | Pulmonary thrombosis |
| 111831046 | 11183104 | 5 | Pharyngitis |
| 111831046 | 11183104 | 6 | Vertigo |
| 111831046 | 11183104 | 7 | Crohn's disease |
| 111831046 | 11183104 | 8 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111831046 | 11183104 | HO |
| 111831046 | 11183104 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111831046 | 11183104 | Allergic oedema | |
| 111831046 | 11183104 | Aphthous ulcer | |
| 111831046 | 11183104 | Arthralgia | |
| 111831046 | 11183104 | Back pain | |
| 111831046 | 11183104 | Crohn's disease | |
| 111831046 | 11183104 | Cystitis | |
| 111831046 | 11183104 | Drug hypersensitivity | |
| 111831046 | 11183104 | Drug ineffective | |
| 111831046 | 11183104 | Eye infection | |
| 111831046 | 11183104 | Fatigue | |
| 111831046 | 11183104 | Gastrointestinal stoma complication | |
| 111831046 | 11183104 | Intervertebral disc degeneration | |
| 111831046 | 11183104 | Intestinal polyp | |
| 111831046 | 11183104 | Kidney infection | |
| 111831046 | 11183104 | Mobility decreased | |
| 111831046 | 11183104 | Pharyngitis | |
| 111831046 | 11183104 | Pneumonia | |
| 111831046 | 11183104 | Pulmonary embolism | |
| 111831046 | 11183104 | Pulmonary thrombosis | |
| 111831046 | 11183104 | Rash | |
| 111831046 | 11183104 | Somnolence | |
| 111831046 | 11183104 | Stoma site haemorrhage | |
| 111831046 | 11183104 | Stoma site ulcer | |
| 111831046 | 11183104 | Thrombosis | |
| 111831046 | 11183104 | Vertigo | |
| 111831046 | 11183104 | Vomiting | |
| 111831046 | 11183104 | 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 |
|---|---|---|---|---|---|---|
| 111831046 | 11183104 | 1 | 20090610 | 201412 | 0 | |
| 111831046 | 11183104 | 2 | 201607 | 0 | ||
| 111831046 | 11183104 | 3 | 201607 | 0 | ||
| 111831046 | 11183104 | 5 | 2014 | 2014 | 0 |