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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106601354 | 10660135 | 4 | F | 2006 | 20160926 | 20141217 | 20160929 | PER | US-CELGENEUS-163-20785-14013676 | CELGENE | 0.00 | F | Y | 53.57000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106601354 | 10660135 | 1 | PS | THALOMID | THALIDOMIDE | 1 | Oral | U | 80012AE,B0013BA | 20785 | 50 | MG | CAPSULES | QD | |||||
| 106601354 | 10660135 | 2 | SS | THALOMID | THALIDOMIDE | 1 | Oral | U | 80012AE,B0013BA | 20785 | 100 | MG | CAPSULES | QD | |||||
| 106601354 | 10660135 | 3 | SS | THALOMID | THALIDOMIDE | 1 | Oral | U | 80012AE,B0013BA | 20785 | 50 | MG | CAPSULES | QD | |||||
| 106601354 | 10660135 | 4 | SS | THALOMID | THALIDOMIDE | 1 | Oral | U | 80012AE,B0013BA | 20785 | 50 | MG | CAPSULES | QD | |||||
| 106601354 | 10660135 | 5 | SS | THALOMID | THALIDOMIDE | 1 | Oral | U | 80012AE,B0013BA | 20785 | 50 | MG | CAPSULES | QD | |||||
| 106601354 | 10660135 | 6 | SS | PROLIA | DENOSUMAB | 1 | Oral | U | U | 80012AE | 20785 | 50 | MG | CAPSULES | QD | ||||
| 106601354 | 10660135 | 7 | SS | PROLIA | DENOSUMAB | 1 | Oral | U | U | 80012AE | 20785 | 50 | MG | CAPSULES | QD | ||||
| 106601354 | 10660135 | 8 | SS | PROLIA | DENOSUMAB | 1 | Oral | U | U | 80012AE | 20785 | 50 | MG | CAPSULES | QD | ||||
| 106601354 | 10660135 | 9 | C | Warfarin | WARFARIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 106601354 | 10660135 | 10 | C | CLONIDINE. | CLONIDINE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 106601354 | 10660135 | 11 | C | Iron | IRON | 1 | Unknown | 0 | INJECTION | ||||||||||
| 106601354 | 10660135 | 12 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106601354 | 10660135 | 1 | Systemic lupus erythematosus |
| 106601354 | 10660135 | 2 | Off label use |
| 106601354 | 10660135 | 6 | Systemic lupus erythematosus |
| 106601354 | 10660135 | 9 | Product used for unknown indication |
| 106601354 | 10660135 | 10 | Product used for unknown indication |
| 106601354 | 10660135 | 11 | Product used for unknown indication |
| 106601354 | 10660135 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106601354 | 10660135 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106601354 | 10660135 | Confusional state | |
| 106601354 | 10660135 | Epistaxis | |
| 106601354 | 10660135 | Feeling abnormal | |
| 106601354 | 10660135 | Insomnia | |
| 106601354 | 10660135 | Pyrexia | |
| 106601354 | 10660135 | Renal failure | |
| 106601354 | 10660135 | Somnolence | |
| 106601354 | 10660135 | Tooth disorder | |
| 106601354 | 10660135 | Urinary tract infection | |
| 106601354 | 10660135 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 106601354 | 10660135 | 1 | 200108 | 0 | ||
| 106601354 | 10660135 | 2 | 200205 | 0 | ||
| 106601354 | 10660135 | 3 | 200301 | 0 | ||
| 106601354 | 10660135 | 4 | 2012 | 0 | ||
| 106601354 | 10660135 | 5 | 201403 | 0 | ||
| 106601354 | 10660135 | 6 | 2001 | 0 | ||
| 106601354 | 10660135 | 7 | 200603 | 0 | ||
| 106601354 | 10660135 | 8 | 200811 | 0 |