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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127783241 | 12778324 | 1 | I | 2016 | 20160913 | 20160926 | 20160926 | EXP | CA-JNJFOC-20160915020 | JOHNSON AND JOHNSON | 57.11 | YR | A | M | Y | 92.00000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127783241 | 12778324 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FLM04016 | 0 | 900 | MG | LYOPHILIZED POWDER | ||||||
| 127783241 | 12778324 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FLM04016 | 0 | 900 | MG | LYOPHILIZED POWDER | ||||||
| 127783241 | 12778324 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FLM04016 | 0 | 900 | MG | LYOPHILIZED POWDER | ||||||
| 127783241 | 12778324 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FLM04016 | 103772 | 900 | MG | LYOPHILIZED POWDER | ||||||
| 127783241 | 12778324 | 5 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | U | U | 999999 | UNSPECIFIED | ||||||||
| 127783241 | 12778324 | 6 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127783241 | 12778324 | 7 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 127783241 | 12778324 | 8 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127783241 | 12778324 | 1 | Colitis ulcerative |
| 127783241 | 12778324 | 2 | Colitis ulcerative |
| 127783241 | 12778324 | 3 | Colitis ulcerative |
| 127783241 | 12778324 | 4 | Colitis ulcerative |
| 127783241 | 12778324 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127783241 | 12778324 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127783241 | 12778324 | Fall | |
| 127783241 | 12778324 | Infusion related reaction | |
| 127783241 | 12778324 | Joint swelling | |
| 127783241 | 12778324 | Ligament rupture | |
| 127783241 | 12778324 | Off label use | |
| 127783241 | 12778324 | Product use issue | |
| 127783241 | 12778324 | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 127783241 | 12778324 | 2 | 20160610 | 0 | ||
| 127783241 | 12778324 | 3 | 20160823 | 0 | ||
| 127783241 | 12778324 | 4 | 20160913 | 0 |