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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94574474 | 9457447 | 4 | F | 20130531 | 20160912 | 20130814 | 20160915 | EXP | BE-JNJFOC-20130800454 | JANSSEN | 29.00 | YR | M | Y | 53.10000 | KG | 20160915 | MD | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94574474 | 9457447 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 5 | MG/KG | LYOPHILIZED POWDER | |||||||
| 94574474 | 9457447 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 10 | MG/KG | LYOPHILIZED POWDER | |||||||
| 94574474 | 9457447 | 3 | C | PANTOMED | DEXPANTHENOL | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 94574474 | 9457447 | 4 | C | COLITOFALK | 2 | Oral | 0 | 500 | MG | UNSPECIFIED | BID | ||||||||
| 94574474 | 9457447 | 5 | C | IMURAN | AZATHIOPRINE | 1 | Oral | 0 | 150 | MG | UNSPECIFIED | ||||||||
| 94574474 | 9457447 | 6 | C | SPASMOMEN | 2 | Oral | 0 | 40 | MG | UNSPECIFIED | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 94574474 | 9457447 | 1 | Colitis ulcerative |
| 94574474 | 9457447 | 2 | Colitis ulcerative |
| 94574474 | 9457447 | 3 | Prophylaxis |
| 94574474 | 9457447 | 4 | Colitis ulcerative |
| 94574474 | 9457447 | 5 | Colitis ulcerative |
| 94574474 | 9457447 | 6 | Muscle spasms |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 94574474 | 9457447 | LT |
| 94574474 | 9457447 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 94574474 | 9457447 | Colitis ulcerative | |
| 94574474 | 9457447 | Hypoalbuminaemia | |
| 94574474 | 9457447 | Normochromic normocytic anaemia | |
| 94574474 | 9457447 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 94574474 | 9457447 | 1 | 20130516 | 0 | ||
| 94574474 | 9457447 | 2 | 2013 | 0 | ||
| 94574474 | 9457447 | 3 | 20130531 | 0 | ||
| 94574474 | 9457447 | 4 | 200905 | 0 | ||
| 94574474 | 9457447 | 5 | 201007 | 0 | ||
| 94574474 | 9457447 | 6 | 20130531 | 0 |