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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124432333 | 12443233 | 3 | F | 20080428 | 20160721 | 20160607 | 20160803 | EXP | CA-JNJFOC-20160421479 | JANSSEN | 31.05 | YR | A | F | Y | 66.00000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124432333 | 12443233 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 56 INFUSIONS TILL DATE | Y | U | FKM95011;UNKNOWN;GAM08011;GBM13012 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||
| 124432333 | 12443233 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FKM95011;UNKNOWN;GAM08011;GBM13012 | 0 | LYOPHILIZED POWDER | |||||||
| 124432333 | 12443233 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FKM95011;UNKNOWN;GAM08011;GBM13012 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 124432333 | 12443233 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FKM95011;UNKNOWN;GAM08011;GBM13012 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 124432333 | 12443233 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FKM95011;UNKNOWN;GAM08011;GBM13012 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 124432333 | 12443233 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | FKM95011;UNKNOWN;GAM08011;GBM13012 | 103772 | 300 | MG | LYOPHILIZED POWDER | |||||
| 124432333 | 12443233 | 7 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124432333 | 12443233 | 8 | C | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124432333 | 12443233 | 9 | C | BUSCOPAN | BUTYLSCOPOLAMINE BROMIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124432333 | 12443233 | 10 | C | T4 | LEVOTHYROXINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124432333 | 12443233 | 11 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | 2000 | IU | UNSPECIFIED | QD | |||||||
| 124432333 | 12443233 | 12 | C | MAGNESIUM | MAGNESIUM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124432333 | 12443233 | 1 | Colitis ulcerative |
| 124432333 | 12443233 | 2 | Colitis ulcerative |
| 124432333 | 12443233 | 3 | Colitis ulcerative |
| 124432333 | 12443233 | 4 | Colitis ulcerative |
| 124432333 | 12443233 | 5 | Colitis ulcerative |
| 124432333 | 12443233 | 6 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124432333 | 12443233 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124432333 | 12443233 | Abdominal pain | |
| 124432333 | 12443233 | Anorectal disorder | |
| 124432333 | 12443233 | Dizziness | |
| 124432333 | 12443233 | Fatigue | |
| 124432333 | 12443233 | Feeling abnormal | |
| 124432333 | 12443233 | Frequent bowel movements | |
| 124432333 | 12443233 | General physical health deterioration | |
| 124432333 | 12443233 | Haematochezia | |
| 124432333 | 12443233 | Herpes zoster | |
| 124432333 | 12443233 | Mucous stools | |
| 124432333 | 12443233 | Off label use | |
| 124432333 | 12443233 | Paraesthesia | |
| 124432333 | 12443233 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 124432333 | 12443233 | 2 | 20160421 | 0 | ||
| 124432333 | 12443233 | 3 | 20070418 | 0 | ||
| 124432333 | 12443233 | 4 | 20080428 | 0 | ||
| 124432333 | 12443233 | 5 | 20160602 | 0 | ||
| 124432333 | 12443233 | 6 | 20160721 | 0 |