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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124648725 | 12464872 | 5 | F | 201508 | 20160921 | 20160614 | 20160930 | EXP | BR-JNJFOC-20160609415 | JANSSEN | 67.46 | YR | E | F | Y | 81.00000 | KG | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124648725 | 12464872 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 124648725 | 12464872 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 124648725 | 12464872 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 780 | MG | LYOPHILIZED POWDER | ||||||
| 124648725 | 12464872 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 0 | 780 | MG | LYOPHILIZED POWDER | ||||||
| 124648725 | 12464872 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN;UNKNOWN | 103772 | LYOPHILIZED POWDER | ||||||||
| 124648725 | 12464872 | 6 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 124648725 | 12464872 | 7 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | D | 0 | 25 | MG | UNSPECIFIED | |||||||
| 124648725 | 12464872 | 8 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Unknown | D | 0 | 15 | MG | UNSPECIFIED | |||||||
| 124648725 | 12464872 | 9 | C | RIVOTRIL | CLONAZEPAM | 1 | Unknown | D | 0 | 2 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124648725 | 12464872 | 1 | Crohn's disease |
| 124648725 | 12464872 | 2 | Crohn's disease |
| 124648725 | 12464872 | 3 | Crohn's disease |
| 124648725 | 12464872 | 4 | Crohn's disease |
| 124648725 | 12464872 | 5 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124648725 | 12464872 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124648725 | 12464872 | Anorectal disorder | |
| 124648725 | 12464872 | Choking | |
| 124648725 | 12464872 | Diarrhoea | |
| 124648725 | 12464872 | Drug ineffective | |
| 124648725 | 12464872 | Gastrointestinal motility disorder | |
| 124648725 | 12464872 | Intestinal stenosis | |
| 124648725 | 12464872 | Lipomatosis | |
| 124648725 | 12464872 | Product outer packaging issue | |
| 124648725 | 12464872 | Weight decreased | |
| 124648725 | 12464872 | Weight 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 |
|---|---|---|---|---|---|---|
| 124648725 | 12464872 | 2 | 20150801 | 0 | ||
| 124648725 | 12464872 | 3 | 20160617 | 0 | ||
| 124648725 | 12464872 | 4 | 20160803 | 0 | ||
| 124648725 | 12464872 | 5 | 201604 | 0 |