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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125743153 | 12574315 | 3 | F | 20160201 | 20160915 | 20160720 | 20160923 | EXP | DE-JNJFOC-20160715414 | JANSSEN | 54.45 | YR | A | M | Y | 70.00000 | KG | 20160923 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125743153 | 12574315 | 1 | PS | GOLIMUMAB | GOLIMUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125289 | SOLUTION FOR INJECTION | |||||||
| 125743153 | 12574315 | 2 | SS | INFLECTRA | INFLIXIMAB-DYYB | 1 | Unknown | Y | 0 | 10 | MG/KG | POWDER FOR INJECTION | |||||||
| 125743153 | 12574315 | 3 | SS | INFLECTRA | INFLIXIMAB-DYYB | 1 | Unknown | Y | 0 | 5 | MG/KG | POWDER FOR INJECTION | |||||||
| 125743153 | 12574315 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | Y | 0 | 1 | MG | UNSPECIFIED | |||||||
| 125743153 | 12574315 | 5 | SS | MESALAZINE | MESALAMINE | 1 | Rectal | Y | 0 | 1 | G | SUPPOSITORY | |||||||
| 125743153 | 12574315 | 6 | SS | ENTYVIO | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 0 | 300 | MG | UNSPECIFIED | |||||||
| 125743153 | 12574315 | 7 | SS | PENTASA | MESALAMINE | 1 | Oral | Y | 0 | 4 | G | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125743153 | 12574315 | 1 | Colitis ulcerative |
| 125743153 | 12574315 | 2 | Colitis ulcerative |
| 125743153 | 12574315 | 3 | Colitis ulcerative |
| 125743153 | 12574315 | 4 | Colitis ulcerative |
| 125743153 | 12574315 | 5 | Colitis ulcerative |
| 125743153 | 12574315 | 6 | Colitis ulcerative |
| 125743153 | 12574315 | 7 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125743153 | 12574315 | OT |
| 125743153 | 12574315 | HO |
| 125743153 | 12574315 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125743153 | 12574315 | Circulatory collapse | |
| 125743153 | 12574315 | Colitis ulcerative | |
| 125743153 | 12574315 | Drug ineffective | |
| 125743153 | 12574315 | Gastrointestinal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125743153 | 12574315 | 2 | 20150918 | 0 | ||
| 125743153 | 12574315 | 3 | 20150619 | 0 | ||
| 125743153 | 12574315 | 4 | 20141120 | 201602 | 0 | |
| 125743153 | 12574315 | 5 | 20151113 | 201602 | 0 | |
| 125743153 | 12574315 | 6 | 20151112 | 20160201 | 0 | |
| 125743153 | 12574315 | 7 | 20150522 | 201602 | 0 |