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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123812502 | 12381250 | 2 | F | 20160211 | 20160718 | 20160518 | 20160725 | EXP | US-JNJFOC-20160507055 | JANSSEN | 11.99 | YR | C | F | Y | 39.40000 | KG | 20160725 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123812502 | 12381250 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 123812502 | 12381250 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 123812502 | 12381250 | 3 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123812502 | 12381250 | 4 | C | HUMIRA | ADALIMUMAB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123812502 | 12381250 | 5 | C | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123812502 | 12381250 | 6 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | TAKEN 9.4 ML BY MOUTH | 0 | 300 | MG | SUSPENSION | |||||||
| 123812502 | 12381250 | 7 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 0 | 325 | MG | SUSPENSION | ||||||||
| 123812502 | 12381250 | 8 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | TAKEN 1 CAPSULE BY MOUTH | 0 | 25 | MG | CAPSULE | |||||||
| 123812502 | 12381250 | 9 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | 50 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123812502 | 12381250 | 1 | Crohn's disease |
| 123812502 | 12381250 | 2 | Crohn's disease |
| 123812502 | 12381250 | 6 | Premedication |
| 123812502 | 12381250 | 7 | Premedication |
| 123812502 | 12381250 | 8 | Premedication |
| 123812502 | 12381250 | 9 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123812502 | 12381250 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123812502 | 12381250 | Cellulitis | |
| 123812502 | 12381250 | Drug ineffective | |
| 123812502 | 12381250 | Duodenitis | |
| 123812502 | 12381250 | Fistula | |
| 123812502 | 12381250 | Gastrointestinal stoma output increased | |
| 123812502 | 12381250 | Haematochezia | |
| 123812502 | 12381250 | Intestinal haemorrhage | |
| 123812502 | 12381250 | Iron deficiency anaemia | |
| 123812502 | 12381250 | Off label use | |
| 123812502 | 12381250 | Product use issue | |
| 123812502 | 12381250 | Staphylococcal infection | |
| 123812502 | 12381250 | Stoma site rash |
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 |
|---|---|---|---|---|---|---|
| 123812502 | 12381250 | 2 | 20160211 | 0 | ||
| 123812502 | 12381250 | 3 | 201511 | 0 | ||
| 123812502 | 12381250 | 4 | 201511 | 0 | ||
| 123812502 | 12381250 | 5 | 201511 | 0 |