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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125377092 | 12537709 | 2 | F | 20150825 | 20160725 | 20160707 | 20160808 | EXP | 23167273 | GB-VALIDUS PHARMACEUTICALS LLC-GB-2016VAL000743 | VALIDUS | 77.00 | YR | M | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125377092 | 12537709 | 1 | PS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG, DAILY | Y | UNK | 16273 | 40 | MG | ||||||
| 125377092 | 12537709 | 2 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 20 MG, UNK | Y | UNK | 16273 | 20 | MG | ||||||
| 125377092 | 12537709 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 100 MILLIGRAM(S);DAILY | 500 | MG | U | UNK | 0 | 100 | MG | ||||
| 125377092 | 12537709 | 4 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 40 MILLIGRAM(S);DAILY | U | UNK | 0 | 40 | MG | ||||||
| 125377092 | 12537709 | 5 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 1.5 MILLIGRAM(S);DAILY | 2 | MG | UNK | 0 | 1.5 | MG | |||||
| 125377092 | 12537709 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 1400 MILLIGRAM(S);DAILY | 1400 | MG | U | UNK | 0 | 1400 | MG | ||||
| 125377092 | 12537709 | 7 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 375 MILLIGRAM(S)/SQUARE METER;DAILY | U | UNKNOWN | 0 | 375 | MG/M**2 | INTRAVENOUS INFUSION | |||||
| 125377092 | 12537709 | 8 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 720 MILLIGRAM ;DAILY | U | UNKNOWN | 0 | 720 | MG | INTRAVENOUS INFUSION | |||||
| 125377092 | 12537709 | 9 | SS | VINCRISTINE /00078802/ | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 2 MILLIGRAM(S);DAILY | 2 | MG | U | UNK | 0 | 2 | MG | ||||
| 125377092 | 12537709 | 10 | C | CHLORPHENAMINE | CHLORPHENIRAMINE MALEATE | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 11 | C | ONDANSETRON | ONDANSETRON | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 12 | C | FILGRASTIM | FILGRASTIM | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 13 | C | METOCLOPRAMIDE /00041902/ | METOCLOPRAMIDE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 14 | C | ALLOPURINOL. | ALLOPURINOL | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 15 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 16 | C | DIGOXIN. | DIGOXIN | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 17 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 18 | C | HYDROXYCHLOROQUINE /00072603/ | HYDROXYCHLOROQUINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 125377092 | 12537709 | 19 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125377092 | 12537709 | 1 | Cardiac disorder |
| 125377092 | 12537709 | 3 | Diffuse large B-cell lymphoma |
| 125377092 | 12537709 | 4 | Gastrointestinal haemorrhage |
| 125377092 | 12537709 | 5 | Diffuse large B-cell lymphoma |
| 125377092 | 12537709 | 6 | Diffuse large B-cell lymphoma |
| 125377092 | 12537709 | 7 | Diffuse large B-cell lymphoma |
| 125377092 | 12537709 | 9 | Diffuse large B-cell lymphoma |
| 125377092 | 12537709 | 10 | Prophylaxis |
| 125377092 | 12537709 | 11 | Prophylaxis |
| 125377092 | 12537709 | 12 | Prophylaxis |
| 125377092 | 12537709 | 13 | Prophylaxis |
| 125377092 | 12537709 | 14 | Prophylaxis |
| 125377092 | 12537709 | 15 | Antifungal prophylaxis |
| 125377092 | 12537709 | 16 | Atrial fibrillation |
| 125377092 | 12537709 | 17 | Aortic valve replacement |
| 125377092 | 12537709 | 18 | Rheumatoid arthritis |
| 125377092 | 12537709 | 19 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125377092 | 12537709 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125377092 | 12537709 | Blood lactic acid increased | |
| 125377092 | 12537709 | Hyponatraemia | |
| 125377092 | 12537709 | 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 |
|---|---|---|---|---|---|---|
| 125377092 | 12537709 | 1 | 20150826 | 0 | ||
| 125377092 | 12537709 | 3 | 20150820 | 20150824 | 0 | |
| 125377092 | 12537709 | 4 | 20150826 | 0 | ||
| 125377092 | 12537709 | 5 | 20150821 | 20150821 | 0 | |
| 125377092 | 12537709 | 6 | 20150820 | 20150820 | 0 | |
| 125377092 | 12537709 | 7 | 20150820 | 20150820 | 0 | |
| 125377092 | 12537709 | 8 | 20150820 | 20150820 | 0 | |
| 125377092 | 12537709 | 9 | 20150820 | 20150820 | 0 | |
| 125377092 | 12537709 | 10 | 20150820 | 20150820 | 0 | |
| 125377092 | 12537709 | 11 | 20150820 | 20150820 | 0 | |
| 125377092 | 12537709 | 12 | 20150823 | 20150826 | 0 | |
| 125377092 | 12537709 | 13 | 20150820 | 20150826 | 0 | |
| 125377092 | 12537709 | 14 | 20150815 | 20150826 | 0 | |
| 125377092 | 12537709 | 15 | 20150815 | 20150826 | 0 | |
| 125377092 | 12537709 | 16 | 20150815 | 20150826 | 0 | |
| 125377092 | 12537709 | 17 | 20150826 | 0 | ||
| 125377092 | 12537709 | 18 | 20150814 | 20150826 | 0 | |
| 125377092 | 12537709 | 19 | 201107 | 20150826 | 0 |