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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126419351 | 12641935 | 1 | I | 201607 | 20160805 | 20160810 | 20160810 | EXP | AU-JNJFOC-20160806275 | JANSSEN | 32.99 | YR | A | M | Y | 81.00000 | KG | 20160810 | CN | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126419351 | 12641935 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 2 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 3 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 4 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 5 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 6 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 7 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 8 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 9 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 10 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 11 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 0 | LYOPHILIZED POWDER | |||||||
| 126419351 | 12641935 | 12 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | EGD47012;EHM57011;EJM7300 +MORE | 103772 | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126419351 | 12641935 | 1 | Product used for unknown indication |
| 126419351 | 12641935 | 2 | Product used for unknown indication |
| 126419351 | 12641935 | 3 | Product used for unknown indication |
| 126419351 | 12641935 | 4 | Product used for unknown indication |
| 126419351 | 12641935 | 5 | Product used for unknown indication |
| 126419351 | 12641935 | 6 | Product used for unknown indication |
| 126419351 | 12641935 | 7 | Product used for unknown indication |
| 126419351 | 12641935 | 8 | Product used for unknown indication |
| 126419351 | 12641935 | 9 | Product used for unknown indication |
| 126419351 | 12641935 | 10 | Product used for unknown indication |
| 126419351 | 12641935 | 11 | Product used for unknown indication |
| 126419351 | 12641935 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126419351 | 12641935 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126419351 | 12641935 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 126419351 | 12641935 | 1 | 20151019 | 0 | ||
| 126419351 | 12641935 | 2 | 20150123 | 0 | ||
| 126419351 | 12641935 | 3 | 20150223 | 0 | ||
| 126419351 | 12641935 | 4 | 20150417 | 0 | ||
| 126419351 | 12641935 | 5 | 20150612 | 0 | ||
| 126419351 | 12641935 | 6 | 20150806 | 0 | ||
| 126419351 | 12641935 | 7 | 20150112 | 0 | ||
| 126419351 | 12641935 | 8 | 20151215 | 0 | ||
| 126419351 | 12641935 | 9 | 20160209 | 0 | ||
| 126419351 | 12641935 | 10 | 20160405 | 0 | ||
| 126419351 | 12641935 | 11 | 20160602 | 0 | ||
| 126419351 | 12641935 | 12 | 20160726 | 0 |