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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118351238 | 11835123 | 8 | F | 201511 | 20160824 | 20151215 | 20160903 | EXP | BR-AMGEN-BRASP2015132417 | AMGEN | 51.00 | YR | A | F | Y | 81.00000 | KG | 20160903 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118351238 | 11835123 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, ONCE WEEKLY | U | L21922 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 118351238 | 11835123 | 2 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 TABLET (UNSPECIFIED DOSE), 3X/WEEK | 0 | 1 | DF | TABLET | ||||||||
| 118351238 | 11835123 | 3 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 TABLET (UNSPECIFIED DOSE), 3X/WEEK | 0 | 1 | DF | TABLET | ||||||||
| 118351238 | 11835123 | 4 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 TABLET (UNSPECIFIED DOSE), 3X/WEEK | 0 | 1 | DF | TABLET | ||||||||
| 118351238 | 11835123 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 TABLET (UNSPECIFIED DOSE), 3X/WEEK | 0 | 1 | DF | TABLET | ||||||||
| 118351238 | 11835123 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 TABLET (UNSPECIFIED DOSE), 3X/WEEK | 0 | 1 | DF | TABLET | ||||||||
| 118351238 | 11835123 | 7 | C | PREDNISONE. | PREDNISONE | 1 | ONE TABLET (5 MG), DAILY | 0 | 5 | MG | TABLET | QD | |||||||
| 118351238 | 11835123 | 8 | C | PREDNISONE. | PREDNISONE | 1 | ONE TABLET (5 MG), WEEKLY | 0 | 5 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 9 | C | PREDNISONE. | PREDNISONE | 1 | ONE TABLET (5 MG), WEEKLY | 0 | 5 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 10 | C | PREDNISONE. | PREDNISONE | 1 | ONE TABLET (5 MG), WEEKLY | 0 | 5 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 11 | C | PREDNISONE. | PREDNISONE | 1 | ONE TABLET (5 MG), WEEKLY | 0 | 5 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 12 | C | METHOTREXATE. | METHOTREXATE | 1 | 8 TABLETS OF 2.5MG (20 MG), WEEKLY | 0 | 20 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 13 | C | METHOTREXATE. | METHOTREXATE | 1 | 8 TABLETS OF 2.5MG (20 MG), WEEKLY | 0 | 20 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 14 | C | METHOTREXATE. | METHOTREXATE | 1 | 8 TABLETS OF 2.5MG (20 MG), WEEKLY | 0 | 20 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 15 | C | METHOTREXATE. | METHOTREXATE | 1 | 8 TABLETS OF 2.5MG (20 MG), WEEKLY | 0 | 20 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 16 | C | METHOTREXATE. | METHOTREXATE | 1 | 8 TABLETS OF 2.5MG (20 MG), WEEKLY | 0 | 20 | MG | TABLET | /wk | |||||||
| 118351238 | 11835123 | 17 | C | CALCIUM | CALCIUM | 1 | 4 TABLETS OF 1200MG (4800 MG), DAILY | 0 | 4800 | MG | TABLET | QD | |||||||
| 118351238 | 11835123 | 18 | C | CALCIUM | CALCIUM | 1 | 4 TABLETS OF 1200MG (4800 MG), DAILY | 0 | 4800 | MG | TABLET | ||||||||
| 118351238 | 11835123 | 19 | C | CALCIUM | CALCIUM | 1 | 4 TABLETS OF 1200MG (4800 MG), DAILY | 0 | 4800 | MG | TABLET | ||||||||
| 118351238 | 11835123 | 20 | C | CALCIUM | CALCIUM | 1 | 4 TABLETS OF 1200MG (4800 MG), DAILY | 0 | 4800 | MG | TABLET | ||||||||
| 118351238 | 11835123 | 21 | C | CALCIUM | CALCIUM | 1 | 4 TABLETS OF 1200MG (4800 MG), DAILY | 0 | 4800 | MG | TABLET | ||||||||
| 118351238 | 11835123 | 22 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | 0 | |||||||||||
| 118351238 | 11835123 | 23 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | 0 | |||||||||||
| 118351238 | 11835123 | 24 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | 0 | |||||||||||
| 118351238 | 11835123 | 25 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | 0 | |||||||||||
| 118351238 | 11835123 | 26 | C | PREDNISOLONE. | PREDNISOLONE | 1 | UNK | 0 | |||||||||||
| 118351238 | 11835123 | 27 | C | DEPURA | CHOLECALCIFEROL | 1 | UNK | 0 | |||||||||||
| 118351238 | 11835123 | 28 | C | DEPURA | CHOLECALCIFEROL | 1 | 10 DROPS | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118351238 | 11835123 | 1 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118351238 | 11835123 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118351238 | 11835123 | Abdominal pain | |
| 118351238 | 11835123 | Abdominal pain upper | |
| 118351238 | 11835123 | Anaemia | |
| 118351238 | 11835123 | Asthenia | |
| 118351238 | 11835123 | Bladder disorder | |
| 118351238 | 11835123 | Bladder prolapse | |
| 118351238 | 11835123 | Condition aggravated | |
| 118351238 | 11835123 | Dyspnoea | |
| 118351238 | 11835123 | Gastritis | |
| 118351238 | 11835123 | Haemorrhoids | |
| 118351238 | 11835123 | Injection site discolouration | |
| 118351238 | 11835123 | Injection site haemorrhage | |
| 118351238 | 11835123 | Leiomyoma | |
| 118351238 | 11835123 | Menopausal symptoms | |
| 118351238 | 11835123 | Muscle spasms | |
| 118351238 | 11835123 | Pain in extremity | |
| 118351238 | 11835123 | Sensitivity to weather change | |
| 118351238 | 11835123 | Somnolence | |
| 118351238 | 11835123 | Uterine leiomyoma | |
| 118351238 | 11835123 | Venous injury | |
| 118351238 | 11835123 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 118351238 | 11835123 | 1 | 20140702 | 0 |