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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117484504 | 11748450 | 4 | F | 20150906 | 20160623 | 20151117 | 20160704 | EXP | PHHO2015PL018387 | NOVARTIS | 65.94 | YR | M | Y | 76.00000 | KG | 20160704 | MD | PL | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117484504 | 11748450 | 1 | PS | OFATUMUMAB | OFATUMUMAB | 1 | Intravenous (not otherwise specified) | 1000 MG, UNK | 125326 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 117484504 | 11748450 | 2 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 1960 MG, UNK | Y | 0 | 1960 | MG | |||||||
| 117484504 | 11748450 | 3 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 1600 MG, UNK | Y | 0 | 1600 | MG | |||||||
| 117484504 | 11748450 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 120 MG, UNK | Y | 0 | 120 | MG | |||||||
| 117484504 | 11748450 | 5 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 110 MG, UNK | Y | 0 | 110 | MG | |||||||
| 117484504 | 11748450 | 6 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 1500 MG, BID | 0 | 1500 | MG | BID | |||||||
| 117484504 | 11748450 | 7 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117484504 | 11748450 | 1 | Diffuse large B-cell lymphoma |
| 117484504 | 11748450 | 2 | Diffuse large B-cell lymphoma |
| 117484504 | 11748450 | 4 | Diffuse large B-cell lymphoma |
| 117484504 | 11748450 | 6 | Diffuse large B-cell lymphoma |
| 117484504 | 11748450 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117484504 | 11748450 | OT |
| 117484504 | 11748450 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117484504 | 11748450 | Aspergillus infection | |
| 117484504 | 11748450 | Cytomegalovirus infection | |
| 117484504 | 11748450 | Febrile neutropenia | |
| 117484504 | 11748450 | Hepatotoxicity | |
| 117484504 | 11748450 | Neutropenia | |
| 117484504 | 11748450 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 117484504 | 11748450 | 1 | 20150828 | 0 | ||
| 117484504 | 11748450 | 2 | 20150829 | 20150902 | 0 | |
| 117484504 | 11748450 | 3 | 20151027 | 20151031 | 0 | |
| 117484504 | 11748450 | 4 | 20150829 | 20160902 | 0 | |
| 117484504 | 11748450 | 5 | 20151027 | 20151031 | 0 | |
| 117484504 | 11748450 | 6 | 20150829 | 0 |