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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1033360524 | 10333605 | 24 | F | 20140717 | 20160620 | 20140723 | 20160630 | EXP | TR-ROCHE-1437033 | ROCHE | 63.00 | YR | M | Y | 50.00000 | KG | 20160630 | MD | TR | TR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1033360524 | 10333605 | 1 | PS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | CYCLE 1 DAY 1, DATE OF MOST RECENT DOSE OF OBINUTUZUMAB PRIOR TO SAE FEBRILE NEUTROPENIA ON 15/JUL/2 | 1127029,1145145 | 104405 | 100 | MG | SOLUTION FOR INJECTION | QD | |||||
| 1033360524 | 10333605 | 2 | SS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | CYCLE 1 DAY 2 | 1127029,1145145 | 104405 | 900 | MG | SOLUTION FOR INJECTION | QD | |||||
| 1033360524 | 10333605 | 3 | SS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | CYCLE 1 DAY 8 | 1127029,1145145 | 104405 | 1000 | MG | SOLUTION FOR INJECTION | QD | |||||
| 1033360524 | 10333605 | 4 | SS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE ON 19/AUG/2014, CYCLE 2 DAY 1 | 1127029,1145145 | 104405 | 1000 | MG | SOLUTION FOR INJECTION | QD | |||||
| 1033360524 | 10333605 | 5 | SS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | C1D15 | 1127029,1145145 | 104405 | 1000 | MG | SOLUTION FOR INJECTION | QD | |||||
| 1033360524 | 10333605 | 6 | SS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | C3D1 | 1127029,1145145 | 104405 | 1000 | MG | SOLUTION FOR INJECTION | ||||||
| 1033360524 | 10333605 | 7 | SS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | C4D1?DRUG PERMANENTLY STOPPED ON 15/DEC/2014 | 1127029,1145145 | 104405 | 1000 | MG | SOLUTION FOR INJECTION | ||||||
| 1033360524 | 10333605 | 8 | SS | CHLORAMBUCIL | CHLORAMBUCIL | 1 | Oral | DATE OF MOST RECENT DOSE OF CHLORAMBUCIL PRIOR TO SAE FEBRILE NEUTROPENIA ON 08/JUL/2014?MOST RECENT | 401971 | 0 | 27.5 | MG | TABLET | QD | |||||
| 1033360524 | 10333605 | 9 | SS | CHLORAMBUCIL | CHLORAMBUCIL | 1 | Oral | 401971 | 0 | .5 | MG/KG | TABLET | |||||||
| 1033360524 | 10333605 | 10 | SS | CHLORAMBUCIL | CHLORAMBUCIL | 1 | Oral | 401971 | 0 | .5 | MG/KG | ||||||||
| 1033360524 | 10333605 | 11 | SS | CHLORAMBUCIL | CHLORAMBUCIL | 1 | Oral | 401971 | 0 | .5 | MG/KG | ||||||||
| 1033360524 | 10333605 | 12 | SS | CHLORAMBUCIL | CHLORAMBUCIL | 1 | Oral | C3D1 | 401971 | 0 | .5 | MG/KG | |||||||
| 1033360524 | 10333605 | 13 | SS | CHLORAMBUCIL | CHLORAMBUCIL | 1 | Oral | C3D2 | 401971 | 0 | .5 | MG/KG | |||||||
| 1033360524 | 10333605 | 14 | SS | CHLORAMBUCIL | CHLORAMBUCIL | 1 | Oral | C4D1 | 401971 | 0 | .5 | MG/KG | |||||||
| 1033360524 | 10333605 | 15 | SS | CHLORAMBUCIL | CHLORAMBUCIL | 1 | Oral | C4D15?DRUG PERMANENTLY STOPPED ON 15/DEC/2014 | 401971 | 0 | .5 | MG/KG | TABLET | ||||||
| 1033360524 | 10333605 | 16 | C | INSULIN HUMAN NPH | 2 | Subcutaneous | 0 | 3 | MG | QD | |||||||||
| 1033360524 | 10333605 | 17 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | |||||||||
| 1033360524 | 10333605 | 18 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 1033360524 | 10333605 | 19 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 1033360524 | 10333605 | 20 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 1033360524 | 10333605 | 21 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 1033360524 | 10333605 | 22 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 1033360524 | 10333605 | 23 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 20 | MG | |||||||||
| 1033360524 | 10333605 | 24 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 2 | ML | |||||||||
| 1033360524 | 10333605 | 25 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | |||||||||
| 1033360524 | 10333605 | 26 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | |||||||||
| 1033360524 | 10333605 | 27 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | |||||||||
| 1033360524 | 10333605 | 28 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | |||||||||
| 1033360524 | 10333605 | 29 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | |||||||||
| 1033360524 | 10333605 | 30 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | |||||||||
| 1033360524 | 10333605 | 31 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 80 | MG | |||||||||
| 1033360524 | 10333605 | 32 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 0 | 300 | MG | QD | ||||||||
| 1033360524 | 10333605 | 33 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 1033360524 | 10333605 | 34 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 1033360524 | 10333605 | 35 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 1033360524 | 10333605 | 36 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 1033360524 | 10333605 | 37 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 1033360524 | 10333605 | 38 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 1033360524 | 10333605 | 39 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | |||||||||
| 1033360524 | 10333605 | 40 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 10 | MG | BID | ||||||||
| 1033360524 | 10333605 | 41 | C | ERYTHROCYTE TRANSFUSIONS | 2 | Intravenous (not otherwise specified) | TOTAL DOSE: 1 UNIT | 0 | INFUSION | QD | |||||||||
| 1033360524 | 10333605 | 42 | C | DIATRIZOIC ACID | DIATRIZOIC ACID | 1 | Oral | SUPPLEMENT | 0 | 50 | ML | TID | |||||||
| 1033360524 | 10333605 | 43 | C | IOVERSOL | IOVERSOL | 1 | Intravenous (not otherwise specified) | SUPPLEMENT | 0 | 100 | ML | ||||||||
| 1033360524 | 10333605 | 44 | C | ADRENALIN | EPINEPHRINE | 1 | Intravenous (not otherwise specified) | 0 | .5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1033360524 | 10333605 | 1 | Chronic lymphocytic leukaemia |
| 1033360524 | 10333605 | 8 | Chronic lymphocytic leukaemia |
| 1033360524 | 10333605 | 17 | Prophylaxis |
| 1033360524 | 10333605 | 25 | Prophylaxis |
| 1033360524 | 10333605 | 33 | Prophylaxis |
| 1033360524 | 10333605 | 44 | Cardiac arrest |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1033360524 | 10333605 | DE |
| 1033360524 | 10333605 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1033360524 | 10333605 | Febrile neutropenia | |
| 1033360524 | 10333605 | Neutropenia | |
| 1033360524 | 10333605 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 1033360524 | 10333605 | 1 | 20140708 | 20140708 | 0 | |
| 1033360524 | 10333605 | 2 | 20140709 | 20140709 | 0 | |
| 1033360524 | 10333605 | 3 | 20140715 | 20140715 | 0 | |
| 1033360524 | 10333605 | 4 | 20140819 | 20140819 | 0 | |
| 1033360524 | 10333605 | 5 | 20140722 | 20140722 | 0 | |
| 1033360524 | 10333605 | 6 | 20140912 | 20140912 | 0 | |
| 1033360524 | 10333605 | 7 | 20141103 | 20141103 | 0 | |
| 1033360524 | 10333605 | 8 | 20140708 | 20140708 | 0 | |
| 1033360524 | 10333605 | 9 | 20140722 | 20140722 | 0 | |
| 1033360524 | 10333605 | 10 | 20140819 | 20140819 | 0 | |
| 1033360524 | 10333605 | 11 | 20140902 | 20140902 | 0 | |
| 1033360524 | 10333605 | 12 | 20140912 | 20140912 | 0 | |
| 1033360524 | 10333605 | 13 | 20140927 | 20140927 | 0 | |
| 1033360524 | 10333605 | 14 | 20141103 | 20141103 | 0 | |
| 1033360524 | 10333605 | 15 | 20141118 | 20141118 | 0 | |
| 1033360524 | 10333605 | 16 | 2009 | 0 | ||
| 1033360524 | 10333605 | 17 | 20140708 | 20140708 | 0 | |
| 1033360524 | 10333605 | 18 | 20140709 | 20140709 | 0 | |
| 1033360524 | 10333605 | 19 | 20140715 | 20140715 | 0 | |
| 1033360524 | 10333605 | 20 | 20140722 | 20140722 | 0 | |
| 1033360524 | 10333605 | 21 | 20140819 | 20140819 | 0 | |
| 1033360524 | 10333605 | 22 | 20140912 | 20140912 | 0 | |
| 1033360524 | 10333605 | 23 | 20141103 | 20141103 | 0 | |
| 1033360524 | 10333605 | 24 | 20140717 | 20140717 | 0 | |
| 1033360524 | 10333605 | 25 | 20140708 | 20140708 | 0 | |
| 1033360524 | 10333605 | 26 | 20140709 | 20140709 | 0 | |
| 1033360524 | 10333605 | 27 | 20140715 | 20140715 | 0 | |
| 1033360524 | 10333605 | 28 | 20140722 | 20140722 | 0 | |
| 1033360524 | 10333605 | 29 | 20140819 | 20140819 | 0 | |
| 1033360524 | 10333605 | 30 | 20140912 | 20140912 | 0 | |
| 1033360524 | 10333605 | 31 | 20141103 | 20141103 | 0 | |
| 1033360524 | 10333605 | 32 | 20140707 | 20140714 | 0 | |
| 1033360524 | 10333605 | 33 | 20140708 | 20140708 | 0 | |
| 1033360524 | 10333605 | 34 | 20140709 | 20140709 | 0 | |
| 1033360524 | 10333605 | 35 | 20140715 | 20140715 | 0 | |
| 1033360524 | 10333605 | 36 | 20140722 | 20140722 | 0 | |
| 1033360524 | 10333605 | 37 | 20140819 | 20140819 | 0 | |
| 1033360524 | 10333605 | 38 | 20140912 | 20140912 | 0 | |
| 1033360524 | 10333605 | 39 | 20141103 | 20141103 | 0 | |
| 1033360524 | 10333605 | 40 | 20140717 | 20140717 | 0 | |
| 1033360524 | 10333605 | 41 | 20140903 | 20140905 | 0 | |
| 1033360524 | 10333605 | 42 | 20140611 | 20140611 | 0 | |
| 1033360524 | 10333605 | 43 | 20140612 | 20140612 | 0 | |
| 1033360524 | 10333605 | 44 | 20141220 | 20141221 | 0 |