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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126714535 | 12671453 | 5 | F | 20160801 | 20160825 | 20160822 | 20160902 | EXP | PHHO2016DE011745 | NOVARTIS | 51.00 | YR | M | Y | 77.00000 | KG | 20160902 | MD | COUNTRY NOT SPECIFIED | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126714535 | 12671453 | 1 | PS | OFATUMUMAB | OFATUMUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | 125326 | 300 | MG | SOLUTION FOR INFUSION | |||||||
| 126714535 | 12671453 | 2 | SS | OFATUMUMAB | OFATUMUMAB | 1 | Intravenous (not otherwise specified) | 1000 MG, UNK | 125326 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 126714535 | 12671453 | 3 | SS | BENDAMUSTINE | BENDAMUSTINE | 1 | Intravenous (not otherwise specified) | 137.3 MG, UNK | 0 | 137.3 | MG | ||||||||
| 126714535 | 12671453 | 4 | SS | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | U | 0 | ||||||||||
| 126714535 | 12671453 | 5 | C | COTRIM FORTE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 960 MG, OM (M, W, F) | 0 | 960 | MG | ||||||||
| 126714535 | 12671453 | 6 | C | DIFLUCAN | FLUCONAZOLE | 1 | Oral | 200 MG, UNK | 0 | 200 | MG | ||||||||
| 126714535 | 12671453 | 7 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 1 G, UNK | U | 0 | 1 | G | |||||||
| 126714535 | 12671453 | 8 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Intravenous (not otherwise specified) | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 126714535 | 12671453 | 9 | C | RANITIC | RANITIDINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 50 MG, UNK | U | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126714535 | 12671453 | 1 | Chronic lymphocytic leukaemia |
| 126714535 | 12671453 | 3 | Chronic lymphocytic leukaemia |
| 126714535 | 12671453 | 4 | Product used for unknown indication |
| 126714535 | 12671453 | 5 | Product used for unknown indication |
| 126714535 | 12671453 | 6 | Product used for unknown indication |
| 126714535 | 12671453 | 7 | Product used for unknown indication |
| 126714535 | 12671453 | 8 | Product used for unknown indication |
| 126714535 | 12671453 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126714535 | 12671453 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126714535 | 12671453 | Eosinophilic cellulitis | |
| 126714535 | 12671453 | Infusion related reaction | |
| 126714535 | 12671453 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 126714535 | 12671453 | 1 | 20160805 | 20160805 | 0 | |
| 126714535 | 12671453 | 2 | 20160809 | 0 | ||
| 126714535 | 12671453 | 3 | 20160704 | 20160705 | 0 | |
| 126714535 | 12671453 | 5 | 20160706 | 0 | ||
| 126714535 | 12671453 | 6 | 20160801 | 0 | ||
| 126714535 | 12671453 | 7 | 20160805 | 20160805 | 0 | |
| 126714535 | 12671453 | 8 | 20160805 | 20160805 | 0 | |
| 126714535 | 12671453 | 9 | 20160805 | 20160805 | 0 |