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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123085115 | 12308511 | 5 | F | 201407 | 20160624 | 20160427 | 20160707 | EXP | JP-AMGEN-JPNSP2016050785 | AMGEN | 71.00 | YR | E | M | Y | 55.00000 | KG | 20160706 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123085115 | 12308511 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 6 TIMES MONTHLY | Y | 103795 | 25 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 123085115 | 12308511 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 25 MG, 2X/WEEK | Y | 103795 | 25 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | BIW | |||||
| 123085115 | 12308511 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 4 MG, 2X/WEEK | 0 | 4 | MG | BIW | |||||||
| 123085115 | 12308511 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 6 MG, WEEKLY | 0 | 6 | MG | /wk | |||||||
| 123085115 | 12308511 | 5 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 8 MG, WEEKLY | 0 | 8 | MG | /wk | |||||||
| 123085115 | 12308511 | 6 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 4 MG, WEEKLY | 0 | 4 | MG | /wk | |||||||
| 123085115 | 12308511 | 7 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 4 MG, WEEKLY | 0 | 4 | MG | /wk | |||||||
| 123085115 | 12308511 | 8 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 6 MG, WEEKLY | 0 | 6 | MG | /wk | |||||||
| 123085115 | 12308511 | 9 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 8 MG, WEEKLY | 0 | 8 | MG | /wk | |||||||
| 123085115 | 12308511 | 10 | C | CELECOX | CELECOXIB | 1 | Oral | 100 MG, 2X/DAY | 0 | 100 | MG | BID | |||||||
| 123085115 | 12308511 | 11 | C | GASLON | IRSOGLADINE MALEATE | 1 | Oral | 2 MG, 2X/DAY | 0 | 2 | MG | BID | |||||||
| 123085115 | 12308511 | 12 | C | GASLON | IRSOGLADINE MALEATE | 1 | Oral | 2 MG, 2X/DAY | 0 | 2 | MG | BID | |||||||
| 123085115 | 12308511 | 13 | C | MUCOSOLVAN L | AMBROXOL HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 123085115 | 12308511 | 14 | C | MUCOSOLVAN L | AMBROXOL HYDROCHLORIDE | 1 | Oral | 45 MG, DAILY | 0 | 45 | MG | ||||||||
| 123085115 | 12308511 | 15 | C | ERYTHROCIN /00020901/ | ERYTHROMYCIN ETHYLSUCCINATE | 1 | Oral | 200 MG, 2X/DAY | 0 | 200 | MG | BID | |||||||
| 123085115 | 12308511 | 16 | C | LENDORMIN | BROTIZOLAM | 1 | Oral | 0.25 MG, 1X/DAY | 0 | .25 | MG | QD | |||||||
| 123085115 | 12308511 | 17 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 4 MG, WEEKLY | 0 | 4 | MG | /wk | |||||||
| 123085115 | 12308511 | 18 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 4 MG, WEEKLY | 0 | 4 | MG | /wk | |||||||
| 123085115 | 12308511 | 19 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 6 MG, WEEKLY | 0 | 6 | MG | /wk | |||||||
| 123085115 | 12308511 | 20 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 8 MG, WEEKLY | 0 | 8 | MG | /wk | |||||||
| 123085115 | 12308511 | 21 | C | ERYTHROCIN /00020901/ | ERYTHROMYCIN ETHYLSUCCINATE | 1 | Oral | 200 MG, 2X/DAY | 0 | 200 | MG | BID | |||||||
| 123085115 | 12308511 | 22 | C | BREDININ | MIZORIBINE | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123085115 | 12308511 | 1 | Rheumatoid arthritis |
| 123085115 | 12308511 | 3 | Rheumatoid arthritis |
| 123085115 | 12308511 | 6 | Rheumatoid arthritis |
| 123085115 | 12308511 | 10 | Rheumatoid arthritis |
| 123085115 | 12308511 | 11 | Gastritis prophylaxis |
| 123085115 | 12308511 | 13 | Chronic sinusitis |
| 123085115 | 12308511 | 15 | Chronic sinusitis |
| 123085115 | 12308511 | 16 | Insomnia |
| 123085115 | 12308511 | 17 | Rheumatoid arthritis |
| 123085115 | 12308511 | 21 | Chronic sinusitis |
| 123085115 | 12308511 | 22 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123085115 | 12308511 | HO |
| 123085115 | 12308511 | LT |
| 123085115 | 12308511 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123085115 | 12308511 | Dysarthria | |
| 123085115 | 12308511 | Gait disturbance | |
| 123085115 | 12308511 | Nausea | |
| 123085115 | 12308511 | Pneumocystis jirovecii pneumonia | |
| 123085115 | 12308511 | Pneumonia | |
| 123085115 | 12308511 | Respiratory failure | |
| 123085115 | 12308511 | Therapeutic response 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 |
|---|---|---|---|---|---|---|
| 123085115 | 12308511 | 1 | 2010 | 201407 | 0 | |
| 123085115 | 12308511 | 2 | 20140812 | 0 | ||
| 123085115 | 12308511 | 4 | 201512 | 0 | ||
| 123085115 | 12308511 | 5 | 201603 | 0 | ||
| 123085115 | 12308511 | 6 | 2010 | 201407 | 0 | |
| 123085115 | 12308511 | 7 | 20140812 | 20160112 | 0 | |
| 123085115 | 12308511 | 8 | 20160112 | 20160315 | 0 | |
| 123085115 | 12308511 | 9 | 20160315 | 0 | ||
| 123085115 | 12308511 | 15 | 20150915 | 0 | ||
| 123085115 | 12308511 | 17 | 2010 | 201407 | 0 | |
| 123085115 | 12308511 | 18 | 20140812 | 20160112 | 0 | |
| 123085115 | 12308511 | 19 | 20160112 | 20160315 | 0 | |
| 123085115 | 12308511 | 20 | 20160315 | 0 | ||
| 123085115 | 12308511 | 21 | 20150915 | 0 | ||
| 123085115 | 12308511 | 22 | 2010 | 0 |