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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121196902 | 12119690 | 2 | F | 20160120 | 20160708 | 20160226 | 20160718 | EXP | FR-JNJFOC-20160208594 | JANSSEN | 47.00 | YR | A | M | Y | 78.00000 | KG | 20160718 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121196902 | 12119690 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | 0 | 12.5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 121196902 | 12119690 | 2 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | 103772 | 12.5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 121196902 | 12119690 | 3 | SS | FIDAXOMICIN | FIDAXOMICIN | 1 | Oral | 0 | 400 | MG | TABLET | ||||||||
| 121196902 | 12119690 | 4 | SS | FIDAXOMICIN | FIDAXOMICIN | 1 | Oral | 0 | 400 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121196902 | 12119690 | 1 | Crohn's disease |
| 121196902 | 12119690 | 2 | Crohn's disease |
| 121196902 | 12119690 | 3 | Clostridium difficile infection |
| 121196902 | 12119690 | 4 | Clostridium difficile infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121196902 | 12119690 | HO |
| 121196902 | 12119690 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121196902 | 12119690 | Clostridium difficile infection | |
| 121196902 | 12119690 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 121196902 | 12119690 | 1 | 20151231 | 20151231 | 0 | |
| 121196902 | 12119690 | 2 | 20151022 | 0 | ||
| 121196902 | 12119690 | 3 | 20151217 | 0 | ||
| 121196902 | 12119690 | 4 | 20151227 | 20151227 | 0 |