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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126418772 | 12641877 | 2 | F | 20130619 | 20160906 | 20160810 | 20160909 | EXP | CA-JNJFOC-20160802370 | JANSSEN | 27.56 | YR | A | F | Y | 79.40000 | KG | 20160909 | OT | CA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126418772 | 12641877 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GBM13011;GBM13013 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 126418772 | 12641877 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 25TH DOSE | N | GBM13011;GBM13013 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 126418772 | 12641877 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 26TH INFUSION | N | GBM13011;GBM13013 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 126418772 | 12641877 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 27TH INFUSION | N | GBM13011;GBM13013 | 103772 | 400 | MG | LYOPHILIZED POWDER | |||||
| 126418772 | 12641877 | 5 | SS | KEFLEX | CEPHALEXIN | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 126418772 | 12641877 | 6 | C | HALDOL | HALOPERIDOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126418772 | 12641877 | 7 | C | HYDROMORPHONE | HYDROMORPHONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126418772 | 12641877 | 8 | C | TRIZAC | 2 | Unknown | 0 | UNSPECIFIED | |||||||||||
| 126418772 | 12641877 | 9 | C | PREVACID | LANSOPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126418772 | 12641877 | 10 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126418772 | 12641877 | 11 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126418772 | 12641877 | 1 | Crohn's disease |
| 126418772 | 12641877 | 2 | Crohn's disease |
| 126418772 | 12641877 | 3 | Crohn's disease |
| 126418772 | 12641877 | 4 | Crohn's disease |
| 126418772 | 12641877 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126418772 | 12641877 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126418772 | 12641877 | Abdominal discomfort | |
| 126418772 | 12641877 | Abdominal pain | |
| 126418772 | 12641877 | Change of bowel habit | |
| 126418772 | 12641877 | Device related infection | |
| 126418772 | 12641877 | Frequent bowel movements | |
| 126418772 | 12641877 | General physical health deterioration | |
| 126418772 | 12641877 | Nausea | |
| 126418772 | 12641877 | Off label use | |
| 126418772 | 12641877 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 126418772 | 12641877 | 1 | 20130619 | 0 | ||
| 126418772 | 12641877 | 2 | 20160629 | 0 | ||
| 126418772 | 12641877 | 3 | 20160804 | 0 | ||
| 126418772 | 12641877 | 4 | 20160906 | 0 |