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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126871921 | 12687192 | 1 | I | 20160815 | 20160826 | 20160826 | EXP | AU-CIPLA LTD.-2016AU17572 | CIPLA | HALL J, FINDEISEN J. SUCCESSFUL ETANERCEPT DESENSITIZATION IN A PATIENT WITH SEVERE INJECTION SITE REACTIONS. JOURNAL OF CLINICAL RHEUMATOLOGY. 2013;19:407 TO 408 | 0.00 | Y | 0.00000 | 20160826 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126871921 | 12687192 | 1 | PS | MELOXICAM. | MELOXICAM | 1 | Unknown | 7.5 MG, DAILY | U | 0 | 7.5 | MG | |||||||
| 126871921 | 12687192 | 2 | SS | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126871921 | 12687192 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126871921 | 12687192 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK, LOW DOSE | U | U | 0 | ||||||||
| 126871921 | 12687192 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 126871921 | 12687192 | 6 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 200 MG, BID | U | U | 0 | 200 | MG | BID | |||||
| 126871921 | 12687192 | 7 | SS | Etanercept | ETANERCEPT | 1 | Unknown | UNK, 7 INJECTIONS | Y | Y | 0 | INJECTION | |||||||
| 126871921 | 12687192 | 8 | SS | Etanercept | ETANERCEPT | 1 | Unknown | 0.25 MG, DAYS 1 TO 2 BEGAN WITH A VERY LOW DOSE OF ETANERCEPT WITH INCREASING DOSES (30-120MINUTES) | Y | Y | 0 | .25 | MG | INJECTION | |||||
| 126871921 | 12687192 | 9 | SS | Etanercept | ETANERCEPT | 1 | Unknown | DAY 3 WAS SIMILAR BUT HAD SLIGHTLY HIGHER DOSES | Y | Y | 0 | INJECTION | |||||||
| 126871921 | 12687192 | 10 | SS | Etanercept | ETANERCEPT | 1 | Unknown | 25 MG, DAY 4 | Y | Y | 0 | 25 | MG | INJECTION | |||||
| 126871921 | 12687192 | 11 | SS | Etanercept | ETANERCEPT | 1 | Unknown | 25 MG, SUBSEQUENT DOSING, BIWEEKLY | Y | Y | 0 | 25 | MG | INJECTION | |||||
| 126871921 | 12687192 | 12 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 126871921 | 12687192 | 13 | SS | Hydroxychloroquine | HYDROXYCHLOROQUINE | 1 | Unknown | 200 MG, BID | U | U | 0 | 200 | MG | BID | |||||
| 126871921 | 12687192 | 14 | SS | Adalimumab | ADALIMUMAB | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 126871921 | 12687192 | 15 | SS | Certolizumab | CERTOLIZUMAB | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126871921 | 12687192 | 1 | Rheumatoid arthritis |
| 126871921 | 12687192 | 2 | Rheumatoid arthritis |
| 126871921 | 12687192 | 3 | Rheumatoid arthritis |
| 126871921 | 12687192 | 5 | Rheumatoid arthritis |
| 126871921 | 12687192 | 6 | Rheumatoid arthritis |
| 126871921 | 12687192 | 7 | Rheumatoid arthritis |
| 126871921 | 12687192 | 12 | Rheumatoid arthritis |
| 126871921 | 12687192 | 13 | Rheumatoid arthritis |
| 126871921 | 12687192 | 14 | Rheumatoid arthritis |
| 126871921 | 12687192 | 15 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126871921 | 12687192 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126871921 | 12687192 | Drug ineffective | |
| 126871921 | 12687192 | Drug intolerance | |
| 126871921 | 12687192 | Injection site reaction |
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 |
|---|---|---|---|---|---|---|
| 126871921 | 12687192 | 1 | 201011 | 0 | ||
| 126871921 | 12687192 | 6 | 201011 | 0 | ||
| 126871921 | 12687192 | 7 | 201107 | 0 | ||
| 126871921 | 12687192 | 13 | 201011 | 0 | ||
| 126871921 | 12687192 | 14 | 201102 | 0 | ||
| 126871921 | 12687192 | 15 | 201110 | 0 |