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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127009521 | 12700952 | 1 | I | 20160816 | 20160831 | 20160831 | EXP | IN-MLMSERVICE-20160810-0390355-1 | IN-ALKEM LABORATORIES LIMITED-IN-ALKEM-2016-00151 | ALKEM | 4.00 | YR | M | Y | 0.00000 | 20160830 | CN | GB | IN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127009521 | 12700952 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 15 MG/KG, TID, IN ORAL SUSPENSION OR TABLET FORM | 91249 | 15 | MG/KG | Q8H | ||||||||
| 127009521 | 12700952 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 3 MG/KG, TWO DIVIDED DOSES | 0 | 3 | MG/KG | ||||||||
| 127009521 | 12700952 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 50 MG/KG, ON DAYS 3 AND 4 | 0 | 50 | MG/KG | |||||||||
| 127009521 | 12700952 | 4 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | 30 MG/M2, FOR FIVE DAYS FROM DAY 6 | 0 | 30 | MG/M**2 | |||||||||
| 127009521 | 12700952 | 5 | SS | BUSULFAN. | BUSULFAN | 1 | 0.8 MG/KG, QID, FOR 12 DOSES | 0 | .8 | MG/KG | Q6H | ||||||||
| 127009521 | 12700952 | 6 | SS | MELPHALAN | MELPHALAN | 1 | 140 MG/M2, ON DAY 1 | 0 | 140 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127009521 | 12700952 | 1 | Prophylaxis against graft versus host disease |
| 127009521 | 12700952 | 2 | Prophylaxis against graft versus host disease |
| 127009521 | 12700952 | 3 | Prophylaxis against graft versus host disease |
| 127009521 | 12700952 | 4 | Acute lymphocytic leukaemia |
| 127009521 | 12700952 | 5 | Acute lymphocytic leukaemia |
| 127009521 | 12700952 | 6 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127009521 | 12700952 | LT |
| 127009521 | 12700952 | OT |
| 127009521 | 12700952 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127009521 | 12700952 | Bacterial infection | |
| 127009521 | 12700952 | Cytomegalovirus infection | |
| 127009521 | 12700952 | Drug ineffective | |
| 127009521 | 12700952 | Histiocytosis haematophagic | |
| 127009521 | 12700952 | Rotavirus infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |