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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120693462 | 12069346 | 2 | F | 20160122 | 20160825 | 20160211 | 20160901 | EXP | CA-ABBVIE-16K-028-1556635-00 | ABBVIE | 23.01 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120693462 | 12069346 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | SOLUTION FOR INJECTION | |||||||||
| 120693462 | 12069346 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION | ||||||
| 120693462 | 12069346 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION | |||||||
| 120693462 | 12069346 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 120693462 | 12069346 | 5 | C | PRENATAL VITAMINS | VITAMINS | 1 | 0 | ||||||||||||
| 120693462 | 12069346 | 6 | C | IRON | IRON | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120693462 | 12069346 | 1 | Crohn's disease |
| 120693462 | 12069346 | 5 | Product used for unknown indication |
| 120693462 | 12069346 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120693462 | 12069346 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120693462 | 12069346 | Chills | |
| 120693462 | 12069346 | Crohn's disease | |
| 120693462 | 12069346 | Device difficult to use | |
| 120693462 | 12069346 | Disability | |
| 120693462 | 12069346 | Exposure during pregnancy | |
| 120693462 | 12069346 | Injection site erythema | |
| 120693462 | 12069346 | Malaise | |
| 120693462 | 12069346 | Nausea | |
| 120693462 | 12069346 | Pyrexia | |
| 120693462 | 12069346 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 120693462 | 12069346 | 1 | 20140416 | 201407 | 0 | |
| 120693462 | 12069346 | 2 | 20160121 | 20160121 | 0 | |
| 120693462 | 12069346 | 3 | 20160204 | 20160204 | 0 |