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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125819901 | 12581990 | 1 | I | 20160505 | 20160722 | 20160722 | EXP | US-MLMSERVICE-20160503-0267171-1 | US-STRIDES ARCOLAB LIMITED-2016SP003040 | STRIDES | KANTH KM, SOLORZANO GE, GOLDMAN MD. IMMUNOSUPPRESSANTS: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY: CASE REPORT. REACTIONS. 2016;1601 | 0.00 | Y | 0.00000 | 20160722 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125819901 | 12581990 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 1500 MG, BID | 90055 | 1500 | MG | |||||||||
| 125819901 | 12581990 | 2 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | 3.63 MG/KG, UNK | 0 | 3.63 | MG/KG | |||||||||
| 125819901 | 12581990 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | 40 MG, QD | 0 | 40 | MG | |||||||||
| 125819901 | 12581990 | 4 | SS | RITUXIMAB | RITUXIMAB | 1 | 375 MG/M2, UNK | 0 | 375 | MG/M**2 | |||||||||
| 125819901 | 12581990 | 5 | SS | RITUXIMAB | RITUXIMAB | 1 | 375 MG/M2, UNK | 0 | 375 | MG/M**2 | |||||||||
| 125819901 | 12581990 | 6 | SS | RITUXIMAB | RITUXIMAB | 1 | 375 MG/M2, UNK | 0 | 375 | MG/M**2 | |||||||||
| 125819901 | 12581990 | 7 | SS | RITUXIMAB | RITUXIMAB | 1 | 375 MG/M2, UNK | 0 | 375 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125819901 | 12581990 | 1 | Immunosuppression |
| 125819901 | 12581990 | 2 | Immunosuppression |
| 125819901 | 12581990 | 3 | Immunosuppression |
| 125819901 | 12581990 | 4 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125819901 | 12581990 | DE |
| 125819901 | 12581990 | HO |
| 125819901 | 12581990 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125819901 | 12581990 | Abulia | |
| 125819901 | 12581990 | CSF protein increased | |
| 125819901 | 12581990 | Clonus | |
| 125819901 | 12581990 | Disorientation | |
| 125819901 | 12581990 | Encephalopathy | |
| 125819901 | 12581990 | Hyperreflexia | |
| 125819901 | 12581990 | JC virus infection | |
| 125819901 | 12581990 | Lymphopenia | |
| 125819901 | 12581990 | Progressive multifocal leukoencephalopathy | |
| 125819901 | 12581990 | White matter lesion |
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 |
|---|---|---|---|---|---|---|
| 125819901 | 12581990 | 1 | 200807 | 200908 | 0 | |
| 125819901 | 12581990 | 2 | 200908 | 20110716 | 0 | |
| 125819901 | 12581990 | 3 | 200807 | 200908 | 0 | |
| 125819901 | 12581990 | 4 | 20130614 | 0 | ||
| 125819901 | 12581990 | 5 | 201207 | 0 | ||
| 125819901 | 12581990 | 6 | 200908 | 0 | ||
| 125819901 | 12581990 | 7 | 20130906 | 0 |