Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4331039 | 4096861 | F | 1 | 4331039-2 | 20031002 | 20040318 | 20040331 | EXP | US-JNJFOC-20040201102 | CENTOCOR, INC. | 51 | YR | F | N | 122 | LBS | 20040330 | MD |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4331039 | 1004758724 | PS | INFLIXIMAB (INFLIXIMAB, RECOMBINANT) LYOPHILIZED POWDER | 2 | INTRAVENOUS | 5 , 10; MG/KG, INTRAVENOUS | U | U | |||
| 4331039 | 1004768017 | C | SULFASALAZINE | 1 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4331039 | 1004758724 | CROHN'S DISEASE |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4331039 | DS |
| 4331039 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 4331039 | ANAL FISTULA |
| 4331039 | PAIN |
| 4331039 | RECTAL HAEMORRHAGE |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 4331039 | HP |
| 4331039 | SDY |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4331039 | 1004758724 | 20021230 | |||
| 4331039 | 1004758724 | 20030108 | |||
| 4331039 | 1004758724 | 20030122 | |||
| 4331039 | 1004758724 | 20030304 | |||
| 4331039 | 1004758724 | 20030512 | |||
| 4331039 | 1004758724 | 20030716 | |||
| 4331039 | 1004758724 | 20030924 |