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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1002076111 | 10020761 | 11 | F | 20140306 | 20160627 | 20140319 | 20160630 | EXP | DK-ROCHE-1362382 | ROCHE | 67.08 | YR | M | Y | 90.00000 | KG | 20160630 | MD | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1002076111 | 10020761 | 1 | PS | Obinutuzumab | OBINUTUZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF MOST RECENT DOSE PRIOR TO 1ST OCCURRENCE OF GENERAL MALAISE (250 ML AT 4 MG/ML) TAKEN ON 28/ | H0014,H0012 | 104405 | SOLUTION FOR INFUSION | Q3W | |||||||
| 1002076111 | 10020761 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | DATE OF MOST RECENT DOSE PRIOR TO 1ST OCCURRENCE OF GENERAL MALAISE AND FEBRILE NEUTROPENIA (1600 MG | 0 | Q3W | |||||||||
| 1002076111 | 10020761 | 3 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | DATE OF MOST RECENT DOSE PRIOR TO 1ST OCCURRENCE OF GENERAL MALAISE AND FEBRILE NEUTROPENIA (104 MG) | 0 | Q3W | |||||||||
| 1002076111 | 10020761 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Intravenous bolus | DATE OF MOST RECENT DOSE PRIOR TO 1ST OCCURRENCE OF GENERAL MALAISE AND FEBRILE NEUTROPENIA (2 MG) T | 0 | Q3W | |||||||||
| 1002076111 | 10020761 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | DATE OF MOST RECENT DOSE PRIOR TO 1ST EPISODE OF GENERAL MALAISE AND FEBRILE NEUTROPENIA (100 MG) TA | 0 | Q3W | |||||||||
| 1002076111 | 10020761 | 6 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 7 | C | KODIMAGNYL | 2 | Unknown | 0 | ||||||||||||
| 1002076111 | 10020761 | 8 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 9 | C | TAVEGYL | CLEMASTINE FUMARATE | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 10 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 11 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 12 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 13 | C | GASTRO-TIMELETS | 2 | Unknown | 0 | ||||||||||||
| 1002076111 | 10020761 | 14 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 15 | C | SULFAMETOXAZOL | SULFAMETHOXAZOLE | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 16 | C | EMPERAL | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 17 | C | KODEIN | CODEINE PHOSPHATE | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 18 | C | ACICLODAN | 2 | Unknown | 0 | ||||||||||||
| 1002076111 | 10020761 | 19 | C | SALINE | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 1002076111 | 10020761 | 20 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 1002076111 | 10020761 | 21 | C | Glucose | DEXTROSE | 1 | Intravenous (not otherwise specified) | 0 | 1 | L | |||||||||
| 1002076111 | 10020761 | 22 | C | IMOCLONE | ZOPICLONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1002076111 | 10020761 | 1 | Diffuse large B-cell lymphoma |
| 1002076111 | 10020761 | 2 | Diffuse large B-cell lymphoma |
| 1002076111 | 10020761 | 3 | Diffuse large B-cell lymphoma |
| 1002076111 | 10020761 | 4 | Diffuse large B-cell lymphoma |
| 1002076111 | 10020761 | 5 | Diffuse large B-cell lymphoma |
| 1002076111 | 10020761 | 6 | Prophylaxis |
| 1002076111 | 10020761 | 8 | Premedication |
| 1002076111 | 10020761 | 9 | Premedication |
| 1002076111 | 10020761 | 10 | Premedication |
| 1002076111 | 10020761 | 11 | Hypotension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1002076111 | 10020761 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1002076111 | 10020761 | Febrile neutropenia | |
| 1002076111 | 10020761 | Malaise | |
| 1002076111 | 10020761 | Neutropenia |
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 |
|---|---|---|---|---|---|---|
| 1002076111 | 10020761 | 1 | 20140228 | 0 | ||
| 1002076111 | 10020761 | 2 | 20140228 | 0 | ||
| 1002076111 | 10020761 | 3 | 20140228 | 0 | ||
| 1002076111 | 10020761 | 4 | 20140228 | 0 | ||
| 1002076111 | 10020761 | 5 | 20140228 | 0 | ||
| 1002076111 | 10020761 | 6 | 20140226 | 20140325 | 0 | |
| 1002076111 | 10020761 | 7 | 20140220 | 20140310 | 0 | |
| 1002076111 | 10020761 | 8 | 20140228 | 20140725 | 0 | |
| 1002076111 | 10020761 | 9 | 20140228 | 20140725 | 0 | |
| 1002076111 | 10020761 | 10 | 20140228 | 20140502 | 0 | |
| 1002076111 | 10020761 | 11 | 20140321 | 20140321 | 0 | |
| 1002076111 | 10020761 | 12 | 20140502 | 0 | ||
| 1002076111 | 10020761 | 13 | 20140228 | 20140502 | 0 | |
| 1002076111 | 10020761 | 14 | 20140228 | 20140228 | 0 | |
| 1002076111 | 10020761 | 15 | 20140226 | 20140808 | 0 | |
| 1002076111 | 10020761 | 16 | 20140307 | 20150502 | 0 | |
| 1002076111 | 10020761 | 17 | 20140310 | 20160217 | 0 | |
| 1002076111 | 10020761 | 18 | 20140318 | 20140822 | 0 | |
| 1002076111 | 10020761 | 19 | 20140321 | 20140321 | 0 | |
| 1002076111 | 10020761 | 20 | 20140328 | 20160217 | 0 | |
| 1002076111 | 10020761 | 21 | 20140330 | 20140330 | 0 | |
| 1002076111 | 10020761 | 22 | 20140403 | 20160217 | 0 |