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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125820081 | 12582008 | 1 | I | 20151229 | 20160722 | 20160722 | PER | US-STRIDES ARCOLAB LIMITED-2015SP002547 | STRIDES | 0.00 | Y | 0.00000 | 20160722 | OT | GB | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125820081 | 12582008 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1000 MG, QD | 90055 | 1000 | MG | ||||||||
| 125820081 | 12582008 | 2 | C | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | 400 MG, QD | 0 | 400 | MG | |||||||||
| 125820081 | 12582008 | 3 | C | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | 0 | ||||||||||||
| 125820081 | 12582008 | 4 | C | IMMUNOGLOBULIN /00025201/ | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 180 G, EVERY 4 WEEKS | 0 | 180 | G | ||||||||
| 125820081 | 12582008 | 5 | C | IMMUNOGLOBULIN /00025201/ | HUMAN IMMUNOGLOBULIN G | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125820081 | 12582008 | 1 | Dermatomyositis |
| 125820081 | 12582008 | 2 | Rheumatoid arthritis |
| 125820081 | 12582008 | 3 | Dermatomyositis |
| 125820081 | 12582008 | 4 | Dermatomyositis |
| 125820081 | 12582008 | 5 | Rheumatoid arthritis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125820081 | 12582008 | Exposure during pregnancy | |
| 125820081 | 12582008 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125820081 | 12582008 | 1 | 20141203 | 20151123 | 0 | |
| 125820081 | 12582008 | 2 | 20130317 | 0 |