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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119170182 | 11917018 | 2 | F | 2015 | 20160706 | 20160114 | 20160712 | EXP | BR-JNJFOC-20160104819 | JANSSEN | 31.50 | YR | A | F | Y | 0.00000 | 20160712 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119170182 | 11917018 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 0 | LYOPHILIZED POWDER | ||||||||
| 119170182 | 11917018 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 119170182 | 11917018 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 0 | LYOPHILIZED POWDER | ||||||||
| 119170182 | 11917018 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 119170182 | 11917018 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 0 | LYOPHILIZED POWDER | ||||||||
| 119170182 | 11917018 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 103772 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 119170182 | 11917018 | 7 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 119170182 | 11917018 | 8 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 119170182 | 11917018 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119170182 | 11917018 | 1 | Crohn's disease |
| 119170182 | 11917018 | 2 | Crohn's disease |
| 119170182 | 11917018 | 3 | Colitis |
| 119170182 | 11917018 | 4 | Colitis |
| 119170182 | 11917018 | 5 | Colitis |
| 119170182 | 11917018 | 6 | Colitis |
| 119170182 | 11917018 | 8 | Spinal pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119170182 | 11917018 | OT |
| 119170182 | 11917018 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119170182 | 11917018 | Anal fissure | |
| 119170182 | 11917018 | Anal fistula | |
| 119170182 | 11917018 | Gastritis | |
| 119170182 | 11917018 | Haemorrhoids | |
| 119170182 | 11917018 | Infection | |
| 119170182 | 11917018 | Limb injury | |
| 119170182 | 11917018 | Memory impairment | |
| 119170182 | 11917018 | Pain | |
| 119170182 | 11917018 | Pyrexia | |
| 119170182 | 11917018 | Rash erythematous | |
| 119170182 | 11917018 | Spinal pain |
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 |
|---|---|---|---|---|---|---|
| 119170182 | 11917018 | 1 | 201511 | 0 | ||
| 119170182 | 11917018 | 2 | 2006 | 0 | ||
| 119170182 | 11917018 | 3 | 201511 | 0 | ||
| 119170182 | 11917018 | 4 | 2006 | 0 | ||
| 119170182 | 11917018 | 5 | 201511 | 0 | ||
| 119170182 | 11917018 | 6 | 2006 | 0 | ||
| 119170182 | 11917018 | 8 | 2015 | 0 |