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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103868032 | 10386803 | 2 | F | 201301 | 20160705 | 20140815 | 20160714 | EXP | BR-JNJFOC-20140811349 | JANSSEN | 21.39 | YR | A | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103868032 | 10386803 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | 3 | DF | LYOPHILIZED POWDER | |||||
| 103868032 | 10386803 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 103772 | 3 | DF | LYOPHILIZED POWDER | |||||
| 103868032 | 10386803 | 3 | SS | PENTASA | MESALAMINE | 1 | Rectal | Y | 0 | UNSPECIFIED | |||||||||
| 103868032 | 10386803 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 103868032 | 10386803 | 5 | SS | SODIUM PHOSPHATE | SODIUM PHOSPHATE | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 103868032 | 10386803 | 6 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103868032 | 10386803 | 1 | Crohn's disease |
| 103868032 | 10386803 | 2 | Crohn's disease |
| 103868032 | 10386803 | 3 | Product used for unknown indication |
| 103868032 | 10386803 | 4 | Gastrointestinal inflammation |
| 103868032 | 10386803 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103868032 | 10386803 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103868032 | 10386803 | Colon cancer | |
| 103868032 | 10386803 | Diarrhoea haemorrhagic | |
| 103868032 | 10386803 | Drug resistance | |
| 103868032 | 10386803 | Exposure during pregnancy | |
| 103868032 | 10386803 | Off label use | |
| 103868032 | 10386803 | 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 |
|---|---|---|---|---|---|---|
| 103868032 | 10386803 | 1 | 201501 | 201606 | 0 | |
| 103868032 | 10386803 | 2 | 20130101 | 20140318 | 0 | |
| 103868032 | 10386803 | 3 | 20140318 | 0 | ||
| 103868032 | 10386803 | 4 | 201407 | 0 | ||
| 103868032 | 10386803 | 5 | 20140318 | 0 |