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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125838122 | 12583812 | 2 | F | 20160725 | 20160722 | 20160803 | EXP | FR-BAXTER-2016BAX037667 | BAXTER | 57.00 | YR | F | Y | 0.00000 | 20160803 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125838122 | 12583812 | 1 | PS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous bolus | SINGLE INTAKE; 1 BOLUS | 12142 | 1 | DF | POWDER FOR SOLUTION FOR INJECTION | |||||||
| 125838122 | 12583812 | 2 | SS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Intravenous bolus | SECOND BOLUS | 12142 | POWDER FOR SOLUTION FOR INJECTION | |||||||||
| 125838122 | 12583812 | 3 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous bolus | 3 BOLUS | 0 | 1 | DF | QD | |||||||
| 125838122 | 12583812 | 4 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 0 | ||||||||||||
| 125838122 | 12583812 | 5 | SS | Cortancyl | PREDNISONE | 1 | Unknown | U | 0 | 1 | MG/KG | ||||||||
| 125838122 | 12583812 | 6 | SS | Cortancyl | PREDNISONE | 1 | Unknown | POSOLOGY WAS DECREASED | U | 0 | |||||||||
| 125838122 | 12583812 | 7 | C | Levothyrox | LEVOTHYROXINE | 1 | Unknown | 0 | |||||||||||
| 125838122 | 12583812 | 8 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 0 | |||||||||||
| 125838122 | 12583812 | 9 | C | Inexium | ESOMEPRAZOLE | 1 | Unknown | 0 | |||||||||||
| 125838122 | 12583812 | 10 | C | Coumadine | WARFARIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 125838122 | 12583812 | 11 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125838122 | 12583812 | 1 | Interstitial lung disease |
| 125838122 | 12583812 | 2 | Off label use |
| 125838122 | 12583812 | 3 | Interstitial lung disease |
| 125838122 | 12583812 | 4 | Off label use |
| 125838122 | 12583812 | 5 | Product used for unknown indication |
| 125838122 | 12583812 | 7 | Product used for unknown indication |
| 125838122 | 12583812 | 8 | Product used for unknown indication |
| 125838122 | 12583812 | 9 | Product used for unknown indication |
| 125838122 | 12583812 | 10 | Product used for unknown indication |
| 125838122 | 12583812 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125838122 | 12583812 | OT |
| 125838122 | 12583812 | HO |
| 125838122 | 12583812 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125838122 | 12583812 | Cognitive disorder | |
| 125838122 | 12583812 | Encephalitis | |
| 125838122 | 12583812 | Fall | |
| 125838122 | 12583812 | Hyponatraemia | |
| 125838122 | 12583812 | Orthostatic hypotension |
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 |
|---|---|---|---|---|---|---|
| 125838122 | 12583812 | 1 | 20160112 | 20160112 | 0 | |
| 125838122 | 12583812 | 2 | 20160208 | 0 | ||
| 125838122 | 12583812 | 3 | 20160109 | 20160111 | 0 |