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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105197274 | 10519727 | 4 | F | 201408 | 20160810 | 20141015 | 20160819 | EXP | BR-JNJFOC-20141007259 | JANSSEN | 88.22 | YR | E | M | Y | 60.00000 | KG | 20160819 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105197274 | 10519727 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN | 0 | 200 | MG | LYOPHILIZED POWDER | |||||
| 105197274 | 10519727 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 105197274 | 10519727 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNKNOWN | 103772 | LYOPHILIZED POWDER | |||||||
| 105197274 | 10519727 | 4 | C | ALENIA | BUDESONIDEFORMOTEROL FUMARATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105197274 | 10519727 | 1 | Rheumatoid arthritis |
| 105197274 | 10519727 | 2 | Rheumatoid arthritis |
| 105197274 | 10519727 | 3 | Rheumatoid arthritis |
| 105197274 | 10519727 | 4 | Fatigue |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105197274 | 10519727 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105197274 | 10519727 | Anaemia | |
| 105197274 | 10519727 | Arrhythmia | |
| 105197274 | 10519727 | Drug diversion | |
| 105197274 | 10519727 | Dysentery | |
| 105197274 | 10519727 | Dyspnoea | |
| 105197274 | 10519727 | Gastrointestinal infection | |
| 105197274 | 10519727 | Haemorrhage | |
| 105197274 | 10519727 | Pyrexia | |
| 105197274 | 10519727 | Rheumatoid arthritis | |
| 105197274 | 10519727 | Urinary tract infection | |
| 105197274 | 10519727 | 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 |
|---|---|---|---|---|---|---|
| 105197274 | 10519727 | 2 | 201402 | 0 | ||
| 105197274 | 10519727 | 3 | 201406 | 0 |