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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123218095 | 12321809 | 5 | F | 20150624 | 20160921 | 20160502 | 20160929 | EXP | DE-JNJFOC-20160425449 | JANSSEN | 14.28 | YR | T | M | Y | 60.10000 | KG | 20160929 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123218095 | 12321809 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 123218095 | 12321809 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 500 | MG | LYOPHILIZED POWDER | |||||||
| 123218095 | 12321809 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | LYOPHILIZED POWDER | |||||||||
| 123218095 | 12321809 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | LYOPHILIZED POWDER | |||||||||
| 123218095 | 12321809 | 5 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123218095 | 12321809 | 1 | Crohn's disease |
| 123218095 | 12321809 | 2 | Crohn's disease |
| 123218095 | 12321809 | 3 | Crohn's disease |
| 123218095 | 12321809 | 4 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123218095 | 12321809 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123218095 | 12321809 | Arthralgia | |
| 123218095 | 12321809 | Conjunctivitis | |
| 123218095 | 12321809 | Dermatitis atopic | |
| 123218095 | 12321809 | Gastritis | |
| 123218095 | 12321809 | Inflammatory marker increased | |
| 123218095 | 12321809 | Iron deficiency | |
| 123218095 | 12321809 | Muscle hypertrophy | |
| 123218095 | 12321809 | Myopia |
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 |
|---|---|---|---|---|---|---|
| 123218095 | 12321809 | 1 | 20101008 | 20110726 | 0 | |
| 123218095 | 12321809 | 2 | 20150109 | 20160919 | 0 | |
| 123218095 | 12321809 | 3 | 20080320 | 0 | ||
| 123218095 | 12321809 | 4 | 20130208 | 0 |