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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121561155 | 12156115 | 5 | F | 2016 | 20160916 | 20160307 | 20160920 | EXP | BR-JNJFOC-20160303766 | JANSSEN | 0.00 | A | M | Y | 80.00000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121561155 | 12156115 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 5 | DF | LYOPHILIZED POWDER | ||||||
| 121561155 | 12156115 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 4 VIALS | N | UNKNOWN | 0 | 4 | DF | LYOPHILIZED POWDER | |||||
| 121561155 | 12156115 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 4 VIALS | N | UNKNOWN | 0 | 4 | DF | LYOPHILIZED POWDER | |||||
| 121561155 | 12156115 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 4 VIALS | N | UNKNOWN | 0 | 4 | DF | LYOPHILIZED POWDER | |||||
| 121561155 | 12156115 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 121561155 | 12156115 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | REPORTED AS 4 VIALS | N | UNKNOWN | 103772 | 4 | DF | LYOPHILIZED POWDER | |||||
| 121561155 | 12156115 | 7 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | D | 0 | TABLET | |||||||||
| 121561155 | 12156115 | 8 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Unknown | D | 0 | 25 | MG | UNKNOWN | |||||||
| 121561155 | 12156115 | 9 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | D | 0 | 5 | MG | UNKNOWN | |||||||
| 121561155 | 12156115 | 10 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | D | 0 | 50 | MG | UNKNOWN | |||||||
| 121561155 | 12156115 | 11 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 121561155 | 12156115 | 12 | C | APRESOLINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 1 | Unknown | D | 0 | 25 | MG | UNSPECIFIED | |||||||
| 121561155 | 12156115 | 13 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Unknown | D | 0 | 25 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121561155 | 12156115 | 1 | Crohn's disease |
| 121561155 | 12156115 | 2 | Crohn's disease |
| 121561155 | 12156115 | 3 | Crohn's disease |
| 121561155 | 12156115 | 4 | Crohn's disease |
| 121561155 | 12156115 | 5 | Crohn's disease |
| 121561155 | 12156115 | 6 | Crohn's disease |
| 121561155 | 12156115 | 7 | Crohn's disease |
| 121561155 | 12156115 | 8 | Hypertension |
| 121561155 | 12156115 | 9 | Hypertension |
| 121561155 | 12156115 | 10 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121561155 | 12156115 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121561155 | 12156115 | Drug ineffective | |
| 121561155 | 12156115 | Frequent bowel movements | |
| 121561155 | 12156115 | Peripheral swelling | |
| 121561155 | 12156115 | Sacroiliitis | |
| 121561155 | 12156115 | Vitamin B12 decreased | |
| 121561155 | 12156115 | Weight fluctuation |
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 |
|---|---|---|---|---|---|---|
| 121561155 | 12156115 | 2 | 20150622 | 0 | ||
| 121561155 | 12156115 | 3 | 20150707 | 0 | ||
| 121561155 | 12156115 | 4 | 20150803 | 0 | ||
| 121561155 | 12156115 | 5 | 20160119 | 0 | ||
| 121561155 | 12156115 | 6 | 201605 | 0 | ||
| 121561155 | 12156115 | 7 | 20160721 | 0 |