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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125460963 | 12546096 | 3 | F | 20150130 | 20160915 | 20160711 | 20160923 | EXP | JP-AMGEN-JPNCT2016089575 | AMGEN | 59.00 | YR | A | F | Y | 47.00000 | KG | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125460963 | 12546096 | 1 | PS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 4 MUG/KG, QD | 4 | UG/KG | U | 125268 | 4 | UG/KG | INVESTIGATIONAL DOSAGE FORM | QD | |||
| 125460963 | 12546096 | 2 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 2 MUG/KG, Q2WK | 4 | UG/KG | U | 125268 | 2 | UG/KG | INVESTIGATIONAL DOSAGE FORM | QOW | |||
| 125460963 | 12546096 | 3 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 4 MUG/KG, Q3WK | 4 | UG/KG | U | 125268 | 4 | UG/KG | INVESTIGATIONAL DOSAGE FORM | Q3W | |||
| 125460963 | 12546096 | 4 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 4 MUG/KG, QD | 4 | UG/KG | U | 125268 | 4 | UG/KG | INVESTIGATIONAL DOSAGE FORM | QD | |||
| 125460963 | 12546096 | 5 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 5 MUG/KG, QWK | 4 | UG/KG | U | 125268 | 5 | UG/KG | INVESTIGATIONAL DOSAGE FORM | /wk | |||
| 125460963 | 12546096 | 6 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 5 MUG/KG, QWK | 4 | UG/KG | U | 125268 | 5 | UG/KG | INVESTIGATIONAL DOSAGE FORM | /wk | |||
| 125460963 | 12546096 | 7 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 4 MUG/KG, QD | 4 | UG/KG | U | 125268 | 4 | UG/KG | INVESTIGATIONAL DOSAGE FORM | QD | |||
| 125460963 | 12546096 | 8 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 3 MUG/KG, QD | 4 | UG/KG | U | 125268 | 3 | UG/KG | INVESTIGATIONAL DOSAGE FORM | QD | |||
| 125460963 | 12546096 | 9 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 4 MUG/KG, QD | 4 | UG/KG | U | 125268 | 4 | UG/KG | INVESTIGATIONAL DOSAGE FORM | QD | |||
| 125460963 | 12546096 | 10 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 3 MUG/KG, QD | 4 | UG/KG | U | 125268 | 3 | UG/KG | INVESTIGATIONAL DOSAGE FORM | QD | |||
| 125460963 | 12546096 | 11 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 4 MUG/KG, QWK | 4 | UG/KG | U | 125268 | 4 | UG/KG | INVESTIGATIONAL DOSAGE FORM | /wk | |||
| 125460963 | 12546096 | 12 | SS | romiplostim | ROMIPLOSTIM | 1 | Subcutaneous | 8 MUG/KG, QWK | 4 | UG/KG | U | 125268 | 8 | UG/KG | INVESTIGATIONAL DOSAGE FORM | /wk | |||
| 125460963 | 12546096 | 13 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 4 MG, UNK | 0 | 4 | MG | TABLET | |||||||
| 125460963 | 12546096 | 14 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | TABLET | |||||||
| 125460963 | 12546096 | 15 | SS | IMURAN | AZATHIOPRINE | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | TABLET | |||||||
| 125460963 | 12546096 | 16 | SS | BONZOL | LANSOPRAZOLE | 1 | Oral | 600 MG, UNK | 0 | 600 | MG | TABLET | |||||||
| 125460963 | 12546096 | 17 | SS | BENET | RISEDRONATE SODIUM | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 125460963 | 12546096 | 18 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 125460963 | 12546096 | 19 | C | EDIROL | ELDECALCITOL | 1 | Oral | UNK | 0 | CAPSULE | |||||||||
| 125460963 | 12546096 | 20 | C | ASPARA-CA | CALCIUM ASPARTATE | 1 | Oral | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125460963 | 12546096 | 1 | Immune thrombocytopenic purpura |
| 125460963 | 12546096 | 13 | Immune thrombocytopenic purpura |
| 125460963 | 12546096 | 14 | Immune thrombocytopenic purpura |
| 125460963 | 12546096 | 15 | Immune thrombocytopenic purpura |
| 125460963 | 12546096 | 16 | Immune thrombocytopenic purpura |
| 125460963 | 12546096 | 17 | Osteoporosis |
| 125460963 | 12546096 | 18 | Prophylaxis |
| 125460963 | 12546096 | 19 | Osteoporosis |
| 125460963 | 12546096 | 20 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125460963 | 12546096 | HO |
| 125460963 | 12546096 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125460963 | 12546096 | Brain stem infarction | |
| 125460963 | 12546096 | Dyslipidaemia | |
| 125460963 | 12546096 | Gamma-glutamyltransferase increased | |
| 125460963 | 12546096 | Hypocalcaemia | |
| 125460963 | 12546096 | Insomnia | |
| 125460963 | 12546096 | Jaundice | |
| 125460963 | 12546096 | Liver disorder | |
| 125460963 | 12546096 | Migraine |
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 |
|---|---|---|---|---|---|---|
| 125460963 | 12546096 | 1 | 20141204 | 20141204 | 0 | |
| 125460963 | 12546096 | 2 | 20141220 | 20150105 | 0 | |
| 125460963 | 12546096 | 3 | 20150124 | 20150214 | 0 | |
| 125460963 | 12546096 | 4 | 20150304 | 20150304 | 0 | |
| 125460963 | 12546096 | 5 | 20150307 | 20150314 | 0 | |
| 125460963 | 12546096 | 6 | 20150330 | 20150406 | 0 | |
| 125460963 | 12546096 | 7 | 20150413 | 20150413 | 0 | |
| 125460963 | 12546096 | 8 | 20150420 | 20150420 | 0 | |
| 125460963 | 12546096 | 9 | 20150427 | 20150427 | 0 | |
| 125460963 | 12546096 | 10 | 20150504 | 20150504 | 0 | |
| 125460963 | 12546096 | 11 | 20150511 | 0 | ||
| 125460963 | 12546096 | 13 | 20141121 | 20141212 | 0 | |
| 125460963 | 12546096 | 14 | 20141205 | 20150526 | 0 | |
| 125460963 | 12546096 | 15 | 20141129 | 20150131 | 0 | |
| 125460963 | 12546096 | 16 | 20141213 | 20150131 | 0 |