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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120543217 | 12054321 | 7 | F | 20151225 | 20160805 | 20160209 | 20160810 | EXP | CA-JNJFOC-20160104726 | JANSSEN | 61.65 | YR | A | F | Y | 106.00000 | KG | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120543217 | 12054321 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FIM76015;FKM95011 | 0 | 1000 | MG | LYOPHILIZED POWDER | |||||
| 120543217 | 12054321 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | TOTAL DOSE: 500 MG | N | N | FIM76015;FKM95011 | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||
| 120543217 | 12054321 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FIM76015;FKM95011 | 0 | 1000 | MG | LYOPHILIZED POWDER | |||||
| 120543217 | 12054321 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FIM76015;FKM95011 | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 120543217 | 12054321 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FIM76015;FKM95011 | 103772 | 500 | MG | LYOPHILIZED POWDER | |||||
| 120543217 | 12054321 | 6 | C | RAMIPRIL. | RAMIPRIL | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | BID | |||||||
| 120543217 | 12054321 | 7 | C | INDAPAMIDE. | INDAPAMIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 120543217 | 12054321 | 8 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | .075 | MG | UNSPECIFIED | ||||||||
| 120543217 | 12054321 | 9 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 120543217 | 12054321 | 10 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 120543217 | 12054321 | 11 | C | ZENHALE | FORMOTEROL FUMARATEMOMETASONE FUROATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 120543217 | 12054321 | 12 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 120543217 | 12054321 | 13 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 120543217 | 12054321 | 14 | C | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 120543217 | 12054321 | 15 | C | COVERSYL | PERINDOPRIL | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 120543217 | 12054321 | 16 | C | COVERSYL | PERINDOPRIL | 1 | Unknown | 0 | 8 | MG | UNSPECIFIED | ||||||||
| 120543217 | 12054321 | 17 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | 10 | MG | UNSPECIFIED | QD | |||||||
| 120543217 | 12054321 | 18 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | 0 | 5 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120543217 | 12054321 | 1 | Colitis ulcerative |
| 120543217 | 12054321 | 2 | Colitis ulcerative |
| 120543217 | 12054321 | 3 | Colitis ulcerative |
| 120543217 | 12054321 | 4 | Colitis ulcerative |
| 120543217 | 12054321 | 5 | Colitis ulcerative |
| 120543217 | 12054321 | 12 | Sleep disorder therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120543217 | 12054321 | HO |
| 120543217 | 12054321 | LT |
| 120543217 | 12054321 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120543217 | 12054321 | Arthritis | |
| 120543217 | 12054321 | Bladder transitional cell carcinoma | |
| 120543217 | 12054321 | Blood pressure increased | |
| 120543217 | 12054321 | Colitis ulcerative | |
| 120543217 | 12054321 | Drug ineffective | |
| 120543217 | 12054321 | General physical health deterioration | |
| 120543217 | 12054321 | Renal haemorrhage | |
| 120543217 | 12054321 | Vascular pseudoaneurysm |
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 |
|---|---|---|---|---|---|---|
| 120543217 | 12054321 | 1 | 20160805 | 0 | ||
| 120543217 | 12054321 | 2 | 20150808 | 0 | ||
| 120543217 | 12054321 | 3 | 20150908 | 0 | ||
| 120543217 | 12054321 | 4 | 20160428 | 0 | ||
| 120543217 | 12054321 | 5 | 20160623 | 0 |