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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115120592 | 11512059 | 2 | F | 201411 | 20160713 | 20150916 | 20160722 | EXP | US-ABBVIE-15K-163-1462250-00 | ABBVIE | 19.53 | YR | M | Y | 43.13000 | KG | 20160722 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115120592 | 11512059 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | 1057193 | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 115120592 | 11512059 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE TWO WEEKS AFTER 160 MG DOSE | 1057193 | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 115120592 | 11512059 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1057193 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||
| 115120592 | 11512059 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1057193 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||||
| 115120592 | 11512059 | 5 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 115120592 | 11512059 | 6 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115120592 | 11512059 | 1 | Crohn's disease |
| 115120592 | 11512059 | 5 | Crohn's disease |
| 115120592 | 11512059 | 6 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115120592 | 11512059 | HO |
| 115120592 | 11512059 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115120592 | 11512059 | Anal fistula | |
| 115120592 | 11512059 | Candida infection | |
| 115120592 | 11512059 | Crohn's disease | |
| 115120592 | 11512059 | Drug administered at inappropriate site | |
| 115120592 | 11512059 | Drug ineffective | |
| 115120592 | 11512059 | Fistula | |
| 115120592 | 11512059 | Gastrointestinal disorder postoperative | |
| 115120592 | 11512059 | Ileus | |
| 115120592 | 11512059 | Injection site pain | |
| 115120592 | 11512059 | Injection site pruritus | |
| 115120592 | 11512059 | Malaise | |
| 115120592 | 11512059 | Muscle spasms | |
| 115120592 | 11512059 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 115120592 | 11512059 | 1 | 201411 | 201411 | 0 | |
| 115120592 | 11512059 | 2 | 2014 | 2014 | 0 | |
| 115120592 | 11512059 | 3 | 2014 | 20150704 | 0 |