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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116283869 | 11628386 | 9 | F | 20141215 | 20160809 | 20151014 | 20160815 | EXP | PHHY2014JP144338 | SANDOZ | 68.54 | YR | F | Y | 43.00000 | KG | 20160815 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116283869 | 11628386 | 1 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 10 MG, BID | 2765 | MG | 0 | 10 | MG | TABLET | BID | ||||
| 116283869 | 11628386 | 2 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 10 MG, TID | 2765 | MG | 0 | 10 | MG | TABLET | TID | ||||
| 116283869 | 11628386 | 3 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 10 MG, BID | 2765 | MG | 0 | 10 | MG | TABLET | BID | ||||
| 116283869 | 11628386 | 4 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 10 MG, QD | 2765 | MG | 0 | 10 | MG | TABLET | QD | ||||
| 116283869 | 11628386 | 5 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 5 MG, QD | 2765 | MG | 0 | 5 | MG | TABLET | QD | ||||
| 116283869 | 11628386 | 6 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 5 MG, QD | 2765 | MG | 0 | 5 | MG | TABLET | QD | ||||
| 116283869 | 11628386 | 7 | SS | JAKAFI | RUXOLITINIB | 1 | Oral | 5 MG, QD | 2765 | MG | 0 | 5 | MG | TABLET | QD | ||||
| 116283869 | 11628386 | 8 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 10 MG, UNK | 35 | MG | 80339 | 10 | MG | TABLET | |||||
| 116283869 | 11628386 | 9 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 5 MG, QD | 35 | MG | 80339 | 5 | MG | TABLET | QD | ||||
| 116283869 | 11628386 | 10 | SS | ALKERAN | MELPHALAN | 1 | Oral | 6 MG, UNK | 0 | 6 | MG | TABLET | |||||||
| 116283869 | 11628386 | 11 | SS | LENADEX | DEXAMETHASONE ACETATE | 1 | Oral | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 116283869 | 11628386 | 12 | C | RED BLOOD CELLS | HUMAN RED BLOOD CELL | 1 | Unknown | 2 IU, UNK | 0 | 2 | IU | INJECTION | |||||||
| 116283869 | 11628386 | 13 | C | RED BLOOD CELLS | HUMAN RED BLOOD CELL | 1 | Unknown | 2 IU, UNK | 0 | 2 | IU | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116283869 | 11628386 | 1 | Primary myelofibrosis |
| 116283869 | 11628386 | 8 | Myelofibrosis |
| 116283869 | 11628386 | 10 | Myelofibrosis |
| 116283869 | 11628386 | 11 | Myelofibrosis |
| 116283869 | 11628386 | 12 | Myelofibrosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116283869 | 11628386 | DE |
| 116283869 | 11628386 | HO |
| 116283869 | 11628386 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116283869 | 11628386 | Alanine aminotransferase increased | |
| 116283869 | 11628386 | Anaemia | |
| 116283869 | 11628386 | Aspartate aminotransferase increased | |
| 116283869 | 11628386 | Bacterial infection | |
| 116283869 | 11628386 | Blood pressure systolic increased | |
| 116283869 | 11628386 | Cardiac failure | |
| 116283869 | 11628386 | Cardiomegaly | |
| 116283869 | 11628386 | Diarrhoea | |
| 116283869 | 11628386 | Gingival bleeding | |
| 116283869 | 11628386 | Hypoaesthesia | |
| 116283869 | 11628386 | Hypogammaglobulinaemia | |
| 116283869 | 11628386 | Inflammation | |
| 116283869 | 11628386 | Influenza | |
| 116283869 | 11628386 | Lung infiltration | |
| 116283869 | 11628386 | Malaise | |
| 116283869 | 11628386 | Oedema | |
| 116283869 | 11628386 | Platelet count decreased | |
| 116283869 | 11628386 | Pleural effusion | |
| 116283869 | 11628386 | Pneumonia | |
| 116283869 | 11628386 | Primary hypothyroidism | |
| 116283869 | 11628386 | Primary myelofibrosis | |
| 116283869 | 11628386 | Pulmonary congestion | |
| 116283869 | 11628386 | Pyrexia | |
| 116283869 | 11628386 | Renal impairment | |
| 116283869 | 11628386 | Tooth fracture | |
| 116283869 | 11628386 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 116283869 | 11628386 | 1 | 20141022 | 20141130 | 0 | |
| 116283869 | 11628386 | 2 | 20141201 | 20141215 | 0 | |
| 116283869 | 11628386 | 3 | 20141222 | 20141225 | 0 | |
| 116283869 | 11628386 | 4 | 20150219 | 20150227 | 0 | |
| 116283869 | 11628386 | 5 | 20150310 | 20150826 | 0 | |
| 116283869 | 11628386 | 6 | 20151005 | 20151009 | 0 | |
| 116283869 | 11628386 | 7 | 20151023 | 20160124 | 0 | |
| 116283869 | 11628386 | 8 | 20150108 | 20150223 | 0 | |
| 116283869 | 11628386 | 9 | 20150224 | 20150302 | 0 | |
| 116283869 | 11628386 | 10 | 20150106 | 20151204 | 0 | |
| 116283869 | 11628386 | 11 | 20150106 | 20151204 | 0 | |
| 116283869 | 11628386 | 12 | 20141222 | 20150327 | 0 | |
| 116283869 | 11628386 | 13 | 20150513 | 0 |