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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111994033 | 11199403 | 3 | F | 2015 | 20160721 | 20150618 | 20160802 | EXP | CA-ABBVIE-15K-028-1401397-00 | ABBVIE | 58.29 | YR | F | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111994033 | 11199403 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 60139XD10 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 111994033 | 11199403 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 60139XD10 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | |||||
| 111994033 | 11199403 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111994033 | 11199403 | 1 | Crohn's disease |
| 111994033 | 11199403 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111994033 | 11199403 | HO |
| 111994033 | 11199403 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111994033 | 11199403 | Chills | |
| 111994033 | 11199403 | Colonic fistula | |
| 111994033 | 11199403 | Cough | |
| 111994033 | 11199403 | Diarrhoea | |
| 111994033 | 11199403 | Enteritis | |
| 111994033 | 11199403 | Gastrointestinal disorder | |
| 111994033 | 11199403 | Haemoglobin abnormal | |
| 111994033 | 11199403 | Haemorrhage | |
| 111994033 | 11199403 | Injection site erythema | |
| 111994033 | 11199403 | Injection site irritation | |
| 111994033 | 11199403 | Injection site pain | |
| 111994033 | 11199403 | Liver abscess | |
| 111994033 | 11199403 | Malaise | |
| 111994033 | 11199403 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 111994033 | 11199403 | 1 | 20150429 | 0 | ||
| 111994033 | 11199403 | 2 | 201606 | 0 |