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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127248991 | 12724899 | 1 | I | 2012 | 20160826 | 20160908 | 20160908 | EXP | CA-CONCORDIA PHARMACEUTICALS INC.-GSH201609-004461 | CONCORDIA | 53.00 | YR | F | Y | 0.00000 | 20160908 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127248991 | 12724899 | 1 | PS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | Y | 9768 | ||||||||||
| 127248991 | 12724899 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Y | 0 | |||||||||||
| 127248991 | 12724899 | 3 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | Y | 0 | ||||||||||
| 127248991 | 12724899 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Y | 0 | |||||||||||
| 127248991 | 12724899 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | Y | 0 | ||||||||||
| 127248991 | 12724899 | 6 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | Y | 0 | ||||||||||
| 127248991 | 12724899 | 7 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | ONCE | 0 | INJECTION | |||||||||
| 127248991 | 12724899 | 8 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | ONCE | 0 | ||||||||||
| 127248991 | 12724899 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | TABLET | |||||||||
| 127248991 | 12724899 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127248991 | 12724899 | 1 | Rheumatoid arthritis |
| 127248991 | 12724899 | 2 | Rheumatoid arthritis |
| 127248991 | 12724899 | 4 | Rheumatoid arthritis |
| 127248991 | 12724899 | 6 | Rheumatoid arthritis |
| 127248991 | 12724899 | 7 | Rheumatoid arthritis |
| 127248991 | 12724899 | 8 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127248991 | 12724899 | HO |
| 127248991 | 12724899 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127248991 | 12724899 | Anaphylactic reaction | |
| 127248991 | 12724899 | Condition aggravated | |
| 127248991 | 12724899 | Diabetes mellitus | |
| 127248991 | 12724899 | Drug ineffective | |
| 127248991 | 12724899 | Dyspnoea | |
| 127248991 | 12724899 | Headache | |
| 127248991 | 12724899 | Liver function test increased | |
| 127248991 | 12724899 | Pharyngeal oedema | |
| 127248991 | 12724899 | Rash | |
| 127248991 | 12724899 | Swelling | |
| 127248991 | 12724899 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 127248991 | 12724899 | 1 | 201205 | 201207 | 0 | |
| 127248991 | 12724899 | 2 | 2010 | 0 | ||
| 127248991 | 12724899 | 3 | 201209 | 201305 | 0 | |
| 127248991 | 12724899 | 4 | 2010 | 0 | ||
| 127248991 | 12724899 | 5 | 201201 | 201307 | 0 | |
| 127248991 | 12724899 | 6 | 201205 | 201206 | 0 | |
| 127248991 | 12724899 | 7 | 201309 | 0 | ||
| 127248991 | 12724899 | 8 | 201407 | 0 |