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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125401021 | 12540102 | 1 | I | 20160222 | 20160223 | 20160708 | 20160708 | EXP | JP-NOVOPROD-481627 | NOVO NORDISK | 83.00 | YR | E | M | Y | 60.00000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125401021 | 12540102 | 1 | PS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 40 MG, QD | 760 | MG | UNKNOWN | 103665 | 40 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD | |||
| 125401021 | 12540102 | 2 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 30 MG, QD (5MG EVERY 4 HOURS) | 760 | MG | UNKNOWN | 103665 | 30 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD | |||
| 125401021 | 12540102 | 3 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 15 MG, QD (5MG EVERY 8 HOURS) | 760 | MG | UNKNOWN | 103665 | 15 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD | |||
| 125401021 | 12540102 | 4 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 50 MG, QD | UNKNOWN | 0 | 50 | MG | QD | ||||||
| 125401021 | 12540102 | 5 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 20 MG, QD | UNKNOWN | 0 | 20 | MG | QD | ||||||
| 125401021 | 12540102 | 6 | C | ARTIST | CARVEDILOL | 1 | Oral | 2.5 MG, QD | U | U | UNKNOWN | 0 | 2.5 | MG | QD | ||||
| 125401021 | 12540102 | 7 | C | FLUITRAN | TRICHLORMETHIAZIDE | 1 | Oral | 2 MG, QD | UNKNOWN | 0 | 2 | MG | QD | ||||||
| 125401021 | 12540102 | 8 | C | ALFACALCIDOL | ALFACALCIDOL | 1 | Oral | 0.5 ?G, QD | UNKNOWN | 0 | .5 | UG | QD | ||||||
| 125401021 | 12540102 | 9 | C | PIMOBENDAN | PIMOBENDAN | 1 | Oral | 2.5 MG, QD | U | U | UNKNOWN | 0 | 2.5 | MG | QD | ||||
| 125401021 | 12540102 | 10 | C | TRAMAL | TRAMADOL | 1 | Oral | 150 MG, QD | UNKNOWN | 0 | 150 | MG | QD | ||||||
| 125401021 | 12540102 | 11 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK | U | U | UNKNOWN | 0 | |||||||
| 125401021 | 12540102 | 12 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | 20 MG/ONE EVERY TWO DAYS | UNKNOWN | 0 | |||||||||
| 125401021 | 12540102 | 13 | C | LYRICA | PREGABALIN | 1 | Oral | 25 MG, QD | U | U | UNKNOWN | 0 | 25 | MG | QD | ||||
| 125401021 | 12540102 | 14 | C | RISPERDAL | RISPERIDONE | 1 | Oral | 0.5 MG, QD | UNKNOWN | 0 | .5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125401021 | 12540102 | 1 | Acquired haemophilia |
| 125401021 | 12540102 | 2 | Haemorrhage |
| 125401021 | 12540102 | 3 | Melaena |
| 125401021 | 12540102 | 4 | Acquired haemophilia |
| 125401021 | 12540102 | 6 | Cardiac failure chronic |
| 125401021 | 12540102 | 7 | Cardiac failure chronic |
| 125401021 | 12540102 | 8 | Osteoporosis |
| 125401021 | 12540102 | 9 | Cardiac failure chronic |
| 125401021 | 12540102 | 11 | Acquired haemophilia |
| 125401021 | 12540102 | 12 | Acquired haemophilia |
| 125401021 | 12540102 | 13 | Acquired haemophilia |
| 125401021 | 12540102 | 14 | Delirium |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125401021 | 12540102 | HO |
| 125401021 | 12540102 | DS |
| 125401021 | 12540102 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125401021 | 12540102 | Cerebral infarction |
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 |
|---|---|---|---|---|---|---|
| 125401021 | 12540102 | 1 | 20160113 | 20160201 | 0 | |
| 125401021 | 12540102 | 2 | 20160221 | 0 | ||
| 125401021 | 12540102 | 3 | 20160222 | 20160222 | 0 | |
| 125401021 | 12540102 | 4 | 20160105 | 0 |