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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124919292 | 12491929 | 2 | F | 201303 | 20160801 | 20160623 | 20160803 | EXP | US-JNJFOC-20160615282 | JANSSEN | 31.05 | YR | A | F | Y | 55.34000 | KG | 20160803 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124919292 | 12491929 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 124919292 | 12491929 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 124919292 | 12491929 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 124919292 | 12491929 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 124919292 | 12491929 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 124919292 | 12491929 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 103772 | LYOPHILIZED POWDER | ||||||||
| 124919292 | 12491929 | 7 | C | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 124919292 | 12491929 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 124919292 | 12491929 | 9 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 100 MG TO 50 MG | 0 | UNSPECIFIED | |||||||||
| 124919292 | 12491929 | 10 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | Oral | 0 | 5 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124919292 | 12491929 | 1 | Arthritis |
| 124919292 | 12491929 | 2 | Arthritis |
| 124919292 | 12491929 | 3 | Arthritis |
| 124919292 | 12491929 | 4 | Colitis ulcerative |
| 124919292 | 12491929 | 5 | Colitis ulcerative |
| 124919292 | 12491929 | 6 | Colitis ulcerative |
| 124919292 | 12491929 | 7 | Colitis ulcerative |
| 124919292 | 12491929 | 8 | Colitis ulcerative |
| 124919292 | 12491929 | 9 | Pain |
| 124919292 | 12491929 | 10 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124919292 | 12491929 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124919292 | 12491929 | Arthralgia | |
| 124919292 | 12491929 | Colitis ulcerative | |
| 124919292 | 12491929 | Drug effect decreased | |
| 124919292 | 12491929 | Lupus-like syndrome | |
| 124919292 | 12491929 | Off label use | |
| 124919292 | 12491929 | 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 |
|---|---|---|---|---|---|---|
| 124919292 | 12491929 | 1 | 201303 | 2015 | 0 | |
| 124919292 | 12491929 | 2 | 20160610 | 0 | ||
| 124919292 | 12491929 | 3 | 2015 | 0 | ||
| 124919292 | 12491929 | 4 | 201303 | 2015 | 0 | |
| 124919292 | 12491929 | 5 | 20160610 | 0 | ||
| 124919292 | 12491929 | 6 | 2015 | 0 | ||
| 124919292 | 12491929 | 7 | 2013 | 2013 | 0 | |
| 124919292 | 12491929 | 8 | 201212 | 201308 | 0 | |
| 124919292 | 12491929 | 10 | 201407 | 0 |