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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124958564 | 12495856 | 4 | F | 201605 | 20160825 | 20160624 | 20160829 | EXP | CA-JNJFOC-20160504572 | JANSSEN | 59.15 | YR | A | M | Y | 103.87000 | KG | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124958564 | 12495856 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FKM95011 | 0 | 700 | MG | LYOPHILIZED POWDER | |||||
| 124958564 | 12495856 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FKM95011 | 0 | 700 | MG | LYOPHILIZED POWDER | |||||
| 124958564 | 12495856 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FKM95011 | 0 | 700 | MG | LYOPHILIZED POWDER | |||||
| 124958564 | 12495856 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FKM95011 | 0 | 700 | MG | LYOPHILIZED POWDER | |||||
| 124958564 | 12495856 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FKM95011 | 0 | 700 | MG | LYOPHILIZED POWDER | |||||
| 124958564 | 12495856 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FKM95011 | 0 | 700 | MG | LYOPHILIZED POWDER | |||||
| 124958564 | 12495856 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FKM95011 | 0 | 700 | MG | LYOPHILIZED POWDER | |||||
| 124958564 | 12495856 | 8 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FKM95011 | 103772 | 700 | MG | LYOPHILIZED POWDER | |||||
| 124958564 | 12495856 | 9 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 30 | MG | UNSPECIFIED | ||||||||
| 124958564 | 12495856 | 10 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 0 | 150 | MG | UNSPECIFIED | ||||||||
| 124958564 | 12495856 | 11 | C | ROSUVASTATIN. | ROSUVASTATIN | 1 | Unknown | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 124958564 | 12495856 | 12 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 124958564 | 12495856 | 13 | C | FERROUS GLUCONATE | FERROUS GLUCONATE | 1 | Unknown | 0 | 300 | MG | UNSPECIFIED | ||||||||
| 124958564 | 12495856 | 14 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | 5 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124958564 | 12495856 | 1 | Colitis |
| 124958564 | 12495856 | 2 | Colitis |
| 124958564 | 12495856 | 3 | Colitis |
| 124958564 | 12495856 | 4 | Colitis |
| 124958564 | 12495856 | 5 | Crohn's disease |
| 124958564 | 12495856 | 6 | Crohn's disease |
| 124958564 | 12495856 | 7 | Crohn's disease |
| 124958564 | 12495856 | 8 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124958564 | 12495856 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124958564 | 12495856 | Abdominal pain | |
| 124958564 | 12495856 | Clostridium difficile infection | |
| 124958564 | 12495856 | Diarrhoea | |
| 124958564 | 12495856 | Gastrointestinal infection | |
| 124958564 | 12495856 | Malaise | |
| 124958564 | 12495856 | Osteomyelitis | |
| 124958564 | 12495856 | Peripheral embolism | |
| 124958564 | 12495856 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 124958564 | 12495856 | 1 | 20160504 | 0 | ||
| 124958564 | 12495856 | 2 | 20160706 | 0 | ||
| 124958564 | 12495856 | 3 | 201606 | 0 | ||
| 124958564 | 12495856 | 4 | 20160421 | 0 | ||
| 124958564 | 12495856 | 5 | 201606 | 0 | ||
| 124958564 | 12495856 | 6 | 20160706 | 0 | ||
| 124958564 | 12495856 | 7 | 20160421 | 0 | ||
| 124958564 | 12495856 | 8 | 20160504 | 0 |