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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 73486795 | 7348679 | 5 | F | 20100107 | 20121226 | 20100408 | 20121231 | EXP | PHHY2010JP20486 | NOVARTIS | 72.34 | YR | F | Y | 65.00000 | KG | 20121231 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 73486795 | 7348679 | 1 | PS | ICL670A | 1 | ORAL | 1125 MG, DAILY | D | 21882 | 1125 | MG | Dispersible Tablet | |||||||
| 73486795 | 7348679 | 2 | SS | ICL670A | 1 | ORAL | 500 MG, DAILY | D | 21882 | 500 | MG | Dispersible Tablet | |||||||
| 73486795 | 7348679 | 3 | SS | LOXONIN | 1 | ORAL | 3 DF, (3 TABLET DAILY) | U | 0 | 3 | DF | ||||||||
| 73486795 | 7348679 | 4 | SS | THYMOGLOBULINE | 1 | INTRAVENOUS | 240 MG, UNK | U | 0 | 240 | MG | ||||||||
| 73486795 | 7348679 | 5 | C | NEORAL | 1 | ORAL | 50 MG, UNK | U | 0 | 50 | MG | ||||||||
| 73486795 | 7348679 | 6 | C | NEORAL | 1 | ORAL | 100 MG, UNK | U | 0 | 100 | MG | ||||||||
| 73486795 | 7348679 | 7 | C | GASTER | 1 | ORAL | 40 MG, UNK | U | 0 | 40 | MG | ||||||||
| 73486795 | 7348679 | 8 | C | METHYLCOBALAMIN | 1 | ORAL | 1500 UG, UNK | U | 0 | 1500 | UG | ||||||||
| 73486795 | 7348679 | 9 | C | NEUROTROPIN | 1 | ORAL | 16 DF, UNK | U | 0 | 16 | DF | ||||||||
| 73486795 | 7348679 | 10 | C | BONZOL | 1 | ORAL | 400 MG, UNK | U | 0 | 400 | MG | ||||||||
| 73486795 | 7348679 | 11 | C | LASIX | 1 | ORAL | 20 MG, UNK | U | 0 | 20 | MG | ||||||||
| 73486795 | 7348679 | 12 | C | LASIX | 1 | ORAL | 40 MG, UNK | U | 0 | 40 | MG | ||||||||
| 73486795 | 7348679 | 13 | C | PREDNISOLONE | 1 | ORAL | 25 MG, UNK | U | 0 | 25 | MG | ||||||||
| 73486795 | 7348679 | 14 | C | PREDNISOLONE | 1 | ORAL | 85 MG, UNK | U | 0 | 85 | MG | ||||||||
| 73486795 | 7348679 | 15 | C | PREDNISOLONE | 1 | ORAL | 30 MG, UNK | U | 0 | 30 | MG | ||||||||
| 73486795 | 7348679 | 16 | C | PREDNISOLONE | 1 | ORAL | 15 MG, UNK | U | 0 | 15 | MG | ||||||||
| 73486795 | 7348679 | 17 | C | PREDNISOLONE | 1 | ORAL | 10 MG, UNK | U | 0 | 10 | MG | ||||||||
| 73486795 | 7348679 | 18 | C | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | INTRAVENOUS | 125 MG, UNK | U | 0 | 125 | MG | ||||||||
| 73486795 | 7348679 | 19 | C | PREDONINE | 1 | INTRAVENOUS | 15 MG, UNK | U | 0 | 15 | MG | ||||||||
| 73486795 | 7348679 | 20 | C | SAXIZON | 1 | INTRAVENOUS | 200 MG, UNK | U | 0 | 200 | MG | ||||||||
| 73486795 | 7348679 | 21 | C | CALONAL | 1 | ORAL | 400 MG, UNK | U | 0 | 400 | MG | ||||||||
| 73486795 | 7348679 | 22 | C | CRAVIT | 1 | ORAL | 500 MG, UNK | U | 0 | 500 | MG | ||||||||
| 73486795 | 7348679 | 23 | C | DIFLUCAN | 1 | ORAL | 200 MG, UNK | U | 0 | 200 | MG | ||||||||
| 73486795 | 7348679 | 24 | C | GRAN | 1 | INTRAVENOUS | 600 UG, UNK | U | 0 | 600 | UG | ||||||||
| 73486795 | 7348679 | 25 | C | GRAN | 1 | 300 UG, UNK | U | 0 | 300 | UG | |||||||||
| 73486795 | 7348679 | 26 | C | BAKTAR | 1 | ORAL | 1 G, UNK | U | 0 | 1 | G | ||||||||
| 73486795 | 7348679 | 27 | C | PLATELETS, HUMAN BLOOD | 1 | 20 U, UNK | U | 0 | 20 | DF | |||||||||
| 73486795 | 7348679 | 28 | C | PLATELETS, HUMAN BLOOD | 1 | 10 U, UNK | U | 0 | 10 | DF | |||||||||
| 73486795 | 7348679 | 29 | C | PLATELETS, HUMAN BLOOD | 1 | 20 U, TWICE A WEEK | U | 0 | 20 | DF | |||||||||
| 73486795 | 7348679 | 30 | C | PLATELETS, HUMAN BLOOD | 1 | 20 U, EVERY TWO DAYS | U | 0 | 20 | DF | |||||||||
| 73486795 | 7348679 | 31 | C | PLATELETS, HUMAN BLOOD | 1 | 20 U, EVERY DAY | U | 0 | 20 | DF | |||||||||
| 73486795 | 7348679 | 32 | C | PLATELETS, HUMAN BLOOD | 1 | 20 U, TWICE A WEEK | U | 0 | 20 | DF | |||||||||
| 73486795 | 7348679 | 33 | C | PLATELETS, HUMAN BLOOD | 1 | 20 U, EVERY TWO DAYS | U | 0 | 20 | DF | |||||||||
| 73486795 | 7348679 | 34 | C | PLATELETS, HUMAN BLOOD | 1 | 20 U, TWICE A WEEK | U | 0 | 20 | DF | |||||||||
| 73486795 | 7348679 | 35 | C | ANALGESICS | 1 | U | 0 | ||||||||||||
| 73486795 | 7348679 | 36 | C | ANTIBIOTICS | 1 | U | 0 | ||||||||||||
| 73486795 | 7348679 | 37 | C | DIURETICS | 1 | U | 0 | ||||||||||||
| 73486795 | 7348679 | 38 | C | IMMUNOSUPPRESSANTS | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 73486795 | 7348679 | 1 | Iron overload |
| 73486795 | 7348679 | 3 | Renal disorder |
| 73486795 | 7348679 | 7 | Prophylaxis |
| 73486795 | 7348679 | 8 | Renal disorder |
| 73486795 | 7348679 | 9 | Renal disorder |
| 73486795 | 7348679 | 11 | Renal disorder |
| 73486795 | 7348679 | 20 | Prophylaxis |
| 73486795 | 7348679 | 22 | Prophylaxis |
| 73486795 | 7348679 | 23 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 73486795 | 7348679 | OT |
| 73486795 | 7348679 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 73486795 | 7348679 | Ascites | |
| 73486795 | 7348679 | Blood creatinine increased | |
| 73486795 | 7348679 | Blood urea increased | |
| 73486795 | 7348679 | Blood urine present | |
| 73486795 | 7348679 | Disseminated intravascular coagulation | |
| 73486795 | 7348679 | Duodenal ulcer haemorrhage | |
| 73486795 | 7348679 | Fall | |
| 73486795 | 7348679 | Gastric ulcer haemorrhage | |
| 73486795 | 7348679 | Monocyte count decreased | |
| 73486795 | 7348679 | Multi-organ failure | |
| 73486795 | 7348679 | Pneumonia | |
| 73486795 | 7348679 | Renal impairment | |
| 73486795 | 7348679 | Subdural haematoma | |
| 73486795 | 7348679 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 73486795 | 7348679 | 1 | 20091227 | 20100125 | 0 | |
| 73486795 | 7348679 | 2 | 20100125 | 20100226 | 0 | |
| 73486795 | 7348679 | 3 | 20090219 | 20100226 | 0 | |
| 73486795 | 7348679 | 4 | 20100122 | 20100126 | 0 | |
| 73486795 | 7348679 | 5 | 20091001 | 0 | ||
| 73486795 | 7348679 | 6 | 20100226 | 0 | ||
| 73486795 | 7348679 | 7 | 20090122 | 20100212 | 0 | |
| 73486795 | 7348679 | 8 | 20090219 | 20100226 | 0 | |
| 73486795 | 7348679 | 9 | 20090219 | 20100226 | 0 | |
| 73486795 | 7348679 | 10 | 20091023 | 20100220 | 0 | |
| 73486795 | 7348679 | 11 | 20090509 | 0 | ||
| 73486795 | 7348679 | 12 | 20100226 | 0 | ||
| 73486795 | 7348679 | 13 | 20091223 | 0 | ||
| 73486795 | 7348679 | 17 | 20100226 | 0 | ||
| 73486795 | 7348679 | 18 | 20100122 | 20100126 | 0 | |
| 73486795 | 7348679 | 19 | 20100213 | 20100214 | 0 | |
| 73486795 | 7348679 | 20 | 20100107 | 201002 | 0 | |
| 73486795 | 7348679 | 21 | 20100122 | 20100126 | 0 | |
| 73486795 | 7348679 | 22 | 20100125 | 20100212 | 0 | |
| 73486795 | 7348679 | 23 | 20100122 | 20100212 | 0 | |
| 73486795 | 7348679 | 24 | 20100122 | 0 | ||
| 73486795 | 7348679 | 25 | 20100217 | 0 | ||
| 73486795 | 7348679 | 26 | 20090122 | 20100226 | 0 | |
| 73486795 | 7348679 | 27 | 20100107 | 0 | ||
| 73486795 | 7348679 | 28 | 20100119 | 0 | ||
| 73486795 | 7348679 | 29 | 20100119 | 20100127 | 0 | |
| 73486795 | 7348679 | 30 | 20100127 | 20100131 | 0 | |
| 73486795 | 7348679 | 31 | 20100131 | 20100201 | 0 | |
| 73486795 | 7348679 | 32 | 20100201 | 20100212 | 0 | |
| 73486795 | 7348679 | 33 | 20100212 | 20100216 | 0 | |
| 73486795 | 7348679 | 34 | 20100216 | 20100224 | 0 |