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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119534207 | 11953420 | 7 | F | 20151209 | 20160810 | 20160126 | 20160818 | EXP | CA-JNJFOC-20160118009 | JANSSEN | 54.80 | YR | A | F | Y | 71.50000 | KG | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119534207 | 11953420 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 46 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 119534207 | 11953420 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 119534207 | 11953420 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 47 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 48 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 50 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 49 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 119534207 | 11953420 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 47 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 10 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 46 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 11 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 119534207 | 11953420 | 12 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | |||||
| 119534207 | 11953420 | 13 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 50 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 14 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 49 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 15 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | HAD 48 INFUSIONS | N | U | FKM95012;FKM95011;GCM21013 +MORE | 0 | 500 | MG | LYOPHILIZED POWDER | ||||
| 119534207 | 11953420 | 16 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | FKM95012;FKM95011;GCM21013 +MORE | 103772 | 500 | MG | LYOPHILIZED POWDER | |||||
| 119534207 | 11953420 | 17 | C | MESALAMINE. | MESALAMINE | 1 | Oral | 6 TABLETS | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119534207 | 11953420 | 1 | Crohn's disease |
| 119534207 | 11953420 | 2 | Crohn's disease |
| 119534207 | 11953420 | 3 | Crohn's disease |
| 119534207 | 11953420 | 4 | Crohn's disease |
| 119534207 | 11953420 | 5 | Crohn's disease |
| 119534207 | 11953420 | 6 | Crohn's disease |
| 119534207 | 11953420 | 7 | Crohn's disease |
| 119534207 | 11953420 | 8 | Crohn's disease |
| 119534207 | 11953420 | 9 | Colitis ulcerative |
| 119534207 | 11953420 | 10 | Colitis ulcerative |
| 119534207 | 11953420 | 11 | Colitis ulcerative |
| 119534207 | 11953420 | 12 | Colitis ulcerative |
| 119534207 | 11953420 | 13 | Colitis ulcerative |
| 119534207 | 11953420 | 14 | Colitis ulcerative |
| 119534207 | 11953420 | 15 | Colitis ulcerative |
| 119534207 | 11953420 | 16 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119534207 | 11953420 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119534207 | 11953420 | Anal squamous cell carcinoma | |
| 119534207 | 11953420 | Diarrhoea | |
| 119534207 | 11953420 | Drug ineffective | |
| 119534207 | 11953420 | General physical health deterioration | |
| 119534207 | 11953420 | Haematochezia | |
| 119534207 | 11953420 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 119534207 | 11953420 | 1 | 20151113 | 0 | ||
| 119534207 | 11953420 | 2 | 20100917 | 0 | ||
| 119534207 | 11953420 | 3 | 20090612 | 0 | ||
| 119534207 | 11953420 | 4 | 20160121 | 0 | ||
| 119534207 | 11953420 | 5 | 20160415 | 0 | ||
| 119534207 | 11953420 | 6 | 20160810 | 0 | ||
| 119534207 | 11953420 | 7 | 20160614 | 0 | ||
| 119534207 | 11953420 | 8 | 20070608 | 0 | ||
| 119534207 | 11953420 | 9 | 20160121 | 0 | ||
| 119534207 | 11953420 | 10 | 20151113 | 0 | ||
| 119534207 | 11953420 | 11 | 20100917 | 0 | ||
| 119534207 | 11953420 | 12 | 20070608 | 0 | ||
| 119534207 | 11953420 | 13 | 20160810 | 0 | ||
| 119534207 | 11953420 | 14 | 20160614 | 0 | ||
| 119534207 | 11953420 | 15 | 20160415 | 0 | ||
| 119534207 | 11953420 | 16 | 20090612 | 0 |