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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101956183 | 10195618 | 3 | F | 2014 | 20140530 | 20140527 | 20160726 | EXP | BR-AMGEN INC.-BRASP2014032842 | AMGEN | 9.00 | YR | C | F | Y | 19.00000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101956183 | 10195618 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 25 MG, EVERY 15 DAYS | H04224 | 103795 | 25 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||
| 101956183 | 10195618 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | 103795 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | |||||||||
| 101956183 | 10195618 | 3 | C | METHOTREXATE. | METHOTREXATE | 1 | 4 TABLETS EVERY MONDAY | 0 | 4 | DF | TABLET | /wk | |||||||
| 101956183 | 10195618 | 4 | C | SULFASALAZINE. | SULFASALAZINE | 1 | 1 TABLET IN THE MORNING AND 1 TABLET IN THE AFTERNOON | 0 | 1 | DF | TABLET | BID | |||||||
| 101956183 | 10195618 | 5 | C | FLANAX /00256202/ | 2 | 2 TABLETS A DAY | 0 | 2 | DF | TABLET | QD | ||||||||
| 101956183 | 10195618 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 TABLET EVERY TUESDAY | 0 | 1 | DF | TABLET | /wk | |||||||
| 101956183 | 10195618 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | TABLET | |||||||||||
| 101956183 | 10195618 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 1 TABLET IN THE MORNING | 0 | 1 | DF | TABLET | QD | |||||||
| 101956183 | 10195618 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 101956183 | 10195618 | 1 | Juvenile idiopathic arthritis |
| 101956183 | 10195618 | 3 | Arthritis |
| 101956183 | 10195618 | 4 | Arthritis |
| 101956183 | 10195618 | 5 | Arthritis |
| 101956183 | 10195618 | 6 | Mineral supplementation |
| 101956183 | 10195618 | 7 | Mineral supplementation |
| 101956183 | 10195618 | 8 | Abdominal discomfort |
| 101956183 | 10195618 | 9 | Abdominal discomfort |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 101956183 | 10195618 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 101956183 | 10195618 | Anxiety | |
| 101956183 | 10195618 | Bone atrophy | |
| 101956183 | 10195618 | Crying | |
| 101956183 | 10195618 | General physical condition abnormal | |
| 101956183 | 10195618 | Injection site discolouration | |
| 101956183 | 10195618 | Injection site haemorrhage | |
| 101956183 | 10195618 | Injection site pain | |
| 101956183 | 10195618 | Pain in extremity | |
| 101956183 | 10195618 | Pallor | |
| 101956183 | 10195618 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 101956183 | 10195618 | 1 | 20140430 | 0 | ||
| 101956183 | 10195618 | 3 | 2013 | 0 | ||
| 101956183 | 10195618 | 4 | 2013 | 0 | ||
| 101956183 | 10195618 | 5 | 2013 | 0 | ||
| 101956183 | 10195618 | 6 | 2013 | 0 | ||
| 101956183 | 10195618 | 8 | 201401 | 0 |