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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121131352 | 12113135 | 2 | F | 201602 | 20160706 | 20160225 | 20160716 | PER | US-CELGENEUS-USA-2016024831 | CELGENE | 40.27 | YR | F | Y | 123.00000 | KG | 20160716 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121131352 | 12113135 | 1 | PS | THALOMID | THALIDOMIDE | 1 | Oral | Y | U | UNKNOWN | 20785 | 100 | MG | CAPSULES | QD | ||||
| 121131352 | 12113135 | 2 | SS | THALOMID | THALIDOMIDE | 1 | Oral | Y | U | UNKNOWN | 20785 | 150 | MG | CAPSULES | QD | ||||
| 121131352 | 12113135 | 3 | SS | THALOMID | THALIDOMIDE | 1 | Oral | Y | U | UNKNOWN | 20785 | 200 | MG | CAPSULES | QD | ||||
| 121131352 | 12113135 | 4 | SS | THALOMID | THALIDOMIDE | 1 | Oral | Y | U | UNKNOWN | 20785 | 400 | MG | CAPSULES | |||||
| 121131352 | 12113135 | 5 | SS | THALOMID | THALIDOMIDE | 1 | Oral | 2000 MILLIGRAM | Y | U | UNKNOWN | 20785 | 300 | MG | CAPSULES | QD | |||
| 121131352 | 12113135 | 6 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 0 | 1000 | MG | UNKNOWN | BID | |||||||
| 121131352 | 12113135 | 7 | C | Hydroxychloroquine | HYDROXYCHLOROQUINE | 1 | Unknown | 0 | 200 | MG | UNKNOWN | BID | |||||||
| 121131352 | 12113135 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 5 | MG | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121131352 | 12113135 | 1 | Pyoderma gangrenosum |
| 121131352 | 12113135 | 6 | Lupus nephritis |
| 121131352 | 12113135 | 7 | Lupus nephritis |
| 121131352 | 12113135 | 8 | Lupus nephritis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121131352 | 12113135 | Extra dose administered | |
| 121131352 | 12113135 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 121131352 | 12113135 | 1 | 201511 | 0 | ||
| 121131352 | 12113135 | 2 | 201601 | 0 | ||
| 121131352 | 12113135 | 3 | 201602 | 0 | ||
| 121131352 | 12113135 | 4 | 201602 | 0 | ||
| 121131352 | 12113135 | 5 | 201603 | 0 | ||
| 121131352 | 12113135 | 6 | 201412 | 0 | ||
| 121131352 | 12113135 | 7 | 201412 | 0 | ||
| 121131352 | 12113135 | 8 | 201412 | 0 |