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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122960833 | 12296083 | 3 | F | 2016 | 20160906 | 20160422 | 20160909 | EXP | CA-JNJFOC-20160416647 | JANSSEN | 52.25 | YR | A | F | Y | 60.00000 | KG | 20160909 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122960833 | 12296083 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FJM90015 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 122960833 | 12296083 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FJM90015 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 122960833 | 12296083 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FJM90015 | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 122960833 | 12296083 | 4 | C | CANDESARTAN | CANDESARTAN | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122960833 | 12296083 | 1 | Crohn's disease |
| 122960833 | 12296083 | 2 | Crohn's disease |
| 122960833 | 12296083 | 3 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122960833 | 12296083 | LT |
| 122960833 | 12296083 | OT |
| 122960833 | 12296083 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122960833 | 12296083 | Anxiety | |
| 122960833 | 12296083 | Back pain | |
| 122960833 | 12296083 | Bronchospasm | |
| 122960833 | 12296083 | Chest pain | |
| 122960833 | 12296083 | Cough | |
| 122960833 | 12296083 | Decreased appetite | |
| 122960833 | 12296083 | Dyspnoea | |
| 122960833 | 12296083 | Headache | |
| 122960833 | 12296083 | Hyperhidrosis | |
| 122960833 | 12296083 | Hypertension | |
| 122960833 | 12296083 | Infusion related reaction | |
| 122960833 | 12296083 | Lethargy | |
| 122960833 | 12296083 | Oxygen saturation decreased | |
| 122960833 | 12296083 | Pallor | |
| 122960833 | 12296083 | Tachycardia | |
| 122960833 | 12296083 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 122960833 | 12296083 | 1 | 20160304 | 0 | ||
| 122960833 | 12296083 | 2 | 20160420 | 0 | ||
| 122960833 | 12296083 | 3 | 20160415 | 0 |