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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114450774 | 11445077 | 4 | F | 2015 | 20160805 | 20150902 | 20160822 | EXP | BR-JNJFOC-20150820258 | JANSSEN | 14.40 | YR | T | M | Y | 0.00000 | 20160822 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114450774 | 11445077 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 114450774 | 11445077 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 114450774 | 11445077 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 114450774 | 11445077 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | LYOPHILIZED POWDER | ||||||||
| 114450774 | 11445077 | 5 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | LAST INFUSION | U | UNKNOWN | 103772 | LYOPHILIZED POWDER | |||||||
| 114450774 | 11445077 | 6 | SS | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | 2 DOSES | 0 | UNSPECIFIED | |||||||||
| 114450774 | 11445077 | 7 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 114450774 | 11445077 | 8 | C | OSTEOCERIN | 2 | Unknown | 0 | UNSPECIFIED | |||||||||||
| 114450774 | 11445077 | 9 | C | DOMPERIDONE | DOMPERIDONE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114450774 | 11445077 | 1 | Crohn's disease |
| 114450774 | 11445077 | 2 | Crohn's disease |
| 114450774 | 11445077 | 3 | Crohn's disease |
| 114450774 | 11445077 | 4 | Crohn's disease |
| 114450774 | 11445077 | 5 | Crohn's disease |
| 114450774 | 11445077 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114450774 | 11445077 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114450774 | 11445077 | Abdominal pain | |
| 114450774 | 11445077 | Adverse event | |
| 114450774 | 11445077 | Asthenia | |
| 114450774 | 11445077 | Bacteraemia | |
| 114450774 | 11445077 | Crohn's disease | |
| 114450774 | 11445077 | Dizziness | |
| 114450774 | 11445077 | Drug ineffective | |
| 114450774 | 11445077 | Nausea | |
| 114450774 | 11445077 | Off label use | |
| 114450774 | 11445077 | Product use issue | |
| 114450774 | 11445077 | 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 |
|---|---|---|---|---|---|---|
| 114450774 | 11445077 | 3 | 20150805 | 0 | ||
| 114450774 | 11445077 | 4 | 201504 | 0 | ||
| 114450774 | 11445077 | 5 | 201604 | 0 |