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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116040886 | 11604088 | 6 | F | 20150825 | 20160725 | 20151007 | 20160819 | EXP | GB-WATSON-2015-21390 | WATSON | 77.00 | YR | M | Y | 172.00000 | KG | 20160819 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116040886 | 11604088 | 1 | SS | Vincristine (Unknown) | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 2 MG, DAILY | 10 | MG | U | UNCONFIRMED | 0 | 2 | MG | UNK | QD | ||
| 116040886 | 11604088 | 2 | PS | Prednisolone (Unknown) | PREDNISOLONE | 1 | Oral | 100 MG, DAILY | 500 | MG | U | UNCONFIRMED | 80354 | 100 | MG | UNK | QD | ||
| 116040886 | 11604088 | 3 | SS | Furosemide (Unknown) | FUROSEMIDE | 1 | Oral | 40 MG, DAILY | Y | UNCONFIRMED | 0 | 40 | MG | UNK | QD | ||||
| 116040886 | 11604088 | 4 | SS | Furosemide (Unknown) | FUROSEMIDE | 1 | Oral | 20 MG, UNK | Y | UNCONFIRMED | 0 | 20 | MG | UNK | |||||
| 116040886 | 11604088 | 5 | SS | Omeprazole (Unknown) | OMEPRAZOLE | 1 | Oral | 40 MG, DAILY | U | UNCONFIRMED | 0 | 40 | MG | UNK | QD | ||||
| 116040886 | 11604088 | 6 | SS | Cyclophosphamide (Unknown) | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 1400 MG, DAILY | 7000 | MG | U | UNCONFIRMED | 0 | 1400 | MG | UNK | QD | ||
| 116040886 | 11604088 | 7 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 1.5 MG, DAILY | 6 | MG | 0 | 1.5 | MG | QD | |||||
| 116040886 | 11604088 | 8 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 375 MG/M2, DAILY | 3600 | MG | U | 0 | 375 | MG/M**2 | INFUSION | QD | |||
| 116040886 | 11604088 | 9 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 720 MG, DAILY | 3600 | MG | U | 0 | 720 | MG | INFUSION | QD | |||
| 116040886 | 11604088 | 10 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 300 MG, DAILY | 3000 | MG | U | 0 | 300 | MG | QD | ||||
| 116040886 | 11604088 | 11 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 75 MG, DAILY | U | 0 | 75 | MG | QD | ||||||
| 116040886 | 11604088 | 12 | C | CHLORPHENAMINE | CHLORPHENIRAMINE MALEATE | 1 | Intravenous (not otherwise specified) | 10 MG, DAILY | 50 | MG | U | 0 | 10 | MG | QD | ||||
| 116040886 | 11604088 | 13 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 125 ?G, DAILY | U | 0 | 125 | UG | QD | ||||||
| 116040886 | 11604088 | 14 | C | DIGOXIN. | DIGOXIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 116040886 | 11604088 | 15 | C | FILGRASTIM | FILGRASTIM | 1 | Subcutaneous | 300 ?G, DAILY | 600 | UG | U | 0 | 300 | UG | QD | ||||
| 116040886 | 11604088 | 16 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 50 MG, DAILY | 500 | MG | U | 0 | 50 | MG | QD | ||||
| 116040886 | 11604088 | 17 | C | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Oral | 200 MG, BID | 4400 | MG | U | 0 | 200 | MG | BID | ||||
| 116040886 | 11604088 | 18 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 20 MG, DAILY | U | 0 | 20 | MG | QD | ||||||
| 116040886 | 11604088 | 19 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | UNK (10-20 MG), PRN | U | 0 | |||||||||
| 116040886 | 11604088 | 20 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 8 MG, DAILY | 40 | MG | U | 0 | 8 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116040886 | 11604088 | 1 | Diffuse large B-cell lymphoma |
| 116040886 | 11604088 | 2 | Diffuse large B-cell lymphoma |
| 116040886 | 11604088 | 3 | Cardiac disorder |
| 116040886 | 11604088 | 5 | Gastrointestinal haemorrhage |
| 116040886 | 11604088 | 6 | Diffuse large B-cell lymphoma |
| 116040886 | 11604088 | 7 | Diffuse large B-cell lymphoma |
| 116040886 | 11604088 | 8 | Diffuse large B-cell lymphoma |
| 116040886 | 11604088 | 10 | Prophylaxis |
| 116040886 | 11604088 | 11 | Aortic valve replacement |
| 116040886 | 11604088 | 12 | Unevaluable event |
| 116040886 | 11604088 | 13 | Atrial fibrillation |
| 116040886 | 11604088 | 15 | White blood cell count |
| 116040886 | 11604088 | 16 | Antifungal prophylaxis |
| 116040886 | 11604088 | 17 | Rheumatoid arthritis |
| 116040886 | 11604088 | 18 | Rheumatoid arthritis |
| 116040886 | 11604088 | 19 | Vomiting |
| 116040886 | 11604088 | 20 | Vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116040886 | 11604088 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116040886 | 11604088 | Blood lactic acid increased | |
| 116040886 | 11604088 | Hyponatraemia | |
| 116040886 | 11604088 | Lower respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 116040886 | 11604088 | 1 | 20150820 | 20150820 | 0 | |
| 116040886 | 11604088 | 2 | 20150820 | 20150824 | 0 | |
| 116040886 | 11604088 | 3 | 20150826 | 0 | ||
| 116040886 | 11604088 | 5 | 20150826 | 0 | ||
| 116040886 | 11604088 | 6 | 20150820 | 20150820 | 0 | |
| 116040886 | 11604088 | 7 | 20150821 | 0 | ||
| 116040886 | 11604088 | 8 | 20150820 | 20150820 | 0 | |
| 116040886 | 11604088 | 9 | 20150820 | 20150820 | 0 | |
| 116040886 | 11604088 | 10 | 20150815 | 20150826 | 0 | |
| 116040886 | 11604088 | 11 | 20150826 | 0 | ||
| 116040886 | 11604088 | 12 | 20150820 | 20150820 | 0 | |
| 116040886 | 11604088 | 13 | 20150826 | 0 | ||
| 116040886 | 11604088 | 14 | 20150815 | 20150826 | 0 | |
| 116040886 | 11604088 | 15 | 20150823 | 20150826 | 0 | |
| 116040886 | 11604088 | 16 | 20150815 | 20150826 | 0 | |
| 116040886 | 11604088 | 17 | 20150814 | 20150826 | 0 | |
| 116040886 | 11604088 | 18 | 201107 | 20150826 | 0 | |
| 116040886 | 11604088 | 19 | 20150820 | 20150826 | 0 | |
| 116040886 | 11604088 | 20 | 20150820 | 20150820 | 0 |