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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107791368 | 10779136 | 8 | F | 20140818 | 20160818 | 20150210 | 20160824 | EXP | DE-JNJFOC-20150201523 | JANSSEN | 30.00 | YR | A | M | Y | 68.00000 | KG | 20160824 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107791368 | 10779136 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 300 | MG | LYOPHILIZED POWDER | Q3W | ||||||
| 107791368 | 10779136 | 2 | C | PENTALGIN | 2 | Intravenous (not otherwise specified) | 0 | 3 | G | QD | |||||||||
| 107791368 | 10779136 | 3 | C | PENTALGIN | 2 | Intravenous (not otherwise specified) | 0 | 3 | G | QD | |||||||||
| 107791368 | 10779136 | 4 | C | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 107791368 | 10779136 | 5 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 1 | G | UNSPECIFIED | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107791368 | 10779136 | 1 | Colitis ulcerative |
| 107791368 | 10779136 | 2 | Pyrexia |
| 107791368 | 10779136 | 3 | Pain |
| 107791368 | 10779136 | 4 | Gastrointestinal disorder therapy |
| 107791368 | 10779136 | 5 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107791368 | 10779136 | HO |
| 107791368 | 10779136 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107791368 | 10779136 | Colitis | |
| 107791368 | 10779136 | Colitis ulcerative |
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 |
|---|---|---|---|---|---|---|
| 107791368 | 10779136 | 1 | 20100621 | 20100731 | 0 | |
| 107791368 | 10779136 | 2 | 20141110 | 20141115 | 0 | |
| 107791368 | 10779136 | 3 | 20141110 | 20141115 | 0 | |
| 107791368 | 10779136 | 4 | 20140818 | 20140829 | 0 | |
| 107791368 | 10779136 | 5 | 20140818 | 20140829 | 0 |