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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114540705 | 11454070 | 5 | F | 20080112 | 20160805 | 20150903 | 20160811 | EXP | CA-JNJFOC-20150824309 | JANSSEN | 39.44 | YR | A | M | Y | 118.00000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114540705 | 11454070 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FBM1401315;FJM80011;FJM80012 +MORE | 0 | 3 | MG/KG | LYOPHILIZED POWDER | |||||
| 114540705 | 11454070 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FBM1401315;FJM80011;FJM80012 +MORE | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 114540705 | 11454070 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FBM1401315;FJM80011;FJM80012 +MORE | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 114540705 | 11454070 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FBM1401315;FJM80011;FJM80012 +MORE | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 114540705 | 11454070 | 5 | C | ACCOLATE | ZAFIRLUKAST | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 114540705 | 11454070 | 6 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 0 | 25 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114540705 | 11454070 | 1 | Crohn's disease |
| 114540705 | 11454070 | 2 | Crohn's disease |
| 114540705 | 11454070 | 3 | Crohn's disease |
| 114540705 | 11454070 | 4 | Crohn's disease |
| 114540705 | 11454070 | 5 | Premedication |
| 114540705 | 11454070 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114540705 | 11454070 | HO |
| 114540705 | 11454070 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114540705 | 11454070 | Chills | |
| 114540705 | 11454070 | Drug effect decreased | |
| 114540705 | 11454070 | Drug prescribing error | |
| 114540705 | 11454070 | Ear infection viral | |
| 114540705 | 11454070 | Infection | |
| 114540705 | 11454070 | Off label use | |
| 114540705 | 11454070 | Pain in jaw | |
| 114540705 | 11454070 | Pyrexia | |
| 114540705 | 11454070 | Rash | |
| 114540705 | 11454070 | Skin infection | |
| 114540705 | 11454070 | Viral upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 114540705 | 11454070 | 1 | 20080112 | 20160322 | 0 | |
| 114540705 | 11454070 | 2 | 20071007 | 0 | ||
| 114540705 | 11454070 | 3 | 20071012 | 0 | ||
| 114540705 | 11454070 | 4 | 20071207 | 0 |