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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127596081 | 12759608 | 1 | I | 20130116 | 20160516 | 20160919 | 20160919 | EXP | JP-CELGENEUS-JPN-2016053678 | CELGENE | 64.96 | YR | M | Y | 57.00000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127596081 | 12759608 | 1 | PS | VIDAZA | AZACITIDINE | 1 | Intravenous drip | U | U | 50794 | 60 | MG/M**2 | INJECTION | QD | |||||
| 127596081 | 12759608 | 2 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 3 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 4 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 5 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 6 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 7 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 8 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 9 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 10 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 11 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 12 | SS | VIDAZA | AZACITIDINE | 1 | Other | U | U | 50794 | 60 | MG/M**2 | INJECTION | ||||||
| 127596081 | 12759608 | 13 | SS | VIDAZA | AZACITIDINE | 1 | Intravenous drip | U | U | 50794 | 60 | MG/M**2 | INJECTION | QD | |||||
| 127596081 | 12759608 | 14 | SS | VIDAZA | AZACITIDINE | 1 | Intravenous drip | U | U | 50794 | 60 | MG/M**2 | INJECTION | QD | |||||
| 127596081 | 12759608 | 15 | C | Mecobalamin | METHYLCOBALAMIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 16 | C | Camostat Mesilate | CAMOSTAT MESYLATE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 17 | C | Loxoprofen Sodium Hydrate | LOXOPROFEN SODIUM DIHYDRATE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 18 | C | KETOPROFEN. | KETOPROFEN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 19 | C | Sulfamethoxazole/Trimethoprim | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 20 | C | Deferasirox | DEFERASIROX | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 21 | C | FEBUXOSTAT. | FEBUXOSTAT | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 22 | C | Hydroxycarbamide | HYDROXYUREA | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 23 | C | Sitafloxacin Hydrate | 2 | Unknown | 0 | UNKNOWN | |||||||||||
| 127596081 | 12759608 | 24 | C | Maoto | HERBALS | 1 | Unknown | 0 | GRANULATE | ||||||||||
| 127596081 | 12759608 | 25 | C | MOXIFLOXACIN HYDROCHLORIDE. | MOXIFLOXACIN HYDROCHLORIDE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 127596081 | 12759608 | 26 | C | Meropenem Hydrate | MEROPENEM | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127596081 | 12759608 | 1 | Myelodysplastic syndrome |
| 127596081 | 12759608 | 15 | Product used for unknown indication |
| 127596081 | 12759608 | 16 | Product used for unknown indication |
| 127596081 | 12759608 | 17 | Product used for unknown indication |
| 127596081 | 12759608 | 18 | Product used for unknown indication |
| 127596081 | 12759608 | 19 | Product used for unknown indication |
| 127596081 | 12759608 | 20 | Product used for unknown indication |
| 127596081 | 12759608 | 21 | Product used for unknown indication |
| 127596081 | 12759608 | 22 | Product used for unknown indication |
| 127596081 | 12759608 | 23 | Product used for unknown indication |
| 127596081 | 12759608 | 24 | Product used for unknown indication |
| 127596081 | 12759608 | 25 | Product used for unknown indication |
| 127596081 | 12759608 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127596081 | 12759608 | HO |
| 127596081 | 12759608 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127596081 | 12759608 | Alanine aminotransferase increased | |
| 127596081 | 12759608 | Aspartate aminotransferase increased | |
| 127596081 | 12759608 | Epistaxis | |
| 127596081 | 12759608 | Haemoglobin decreased | |
| 127596081 | 12759608 | Platelet count decreased | |
| 127596081 | 12759608 | Red blood cell count decreased | |
| 127596081 | 12759608 | 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 |
|---|---|---|---|---|---|---|
| 127596081 | 12759608 | 1 | 20130115 | 20130119 | 0 | |
| 127596081 | 12759608 | 2 | 20130213 | 20130217 | 0 | |
| 127596081 | 12759608 | 3 | 20130317 | 20130321 | 0 | |
| 127596081 | 12759608 | 4 | 20130415 | 20130419 | 0 | |
| 127596081 | 12759608 | 5 | 20130520 | 20130524 | 0 | |
| 127596081 | 12759608 | 6 | 20130624 | 20130628 | 0 | |
| 127596081 | 12759608 | 7 | 20130729 | 20130802 | 0 | |
| 127596081 | 12759608 | 8 | 20130902 | 20130906 | 0 | |
| 127596081 | 12759608 | 9 | 20131007 | 20131011 | 0 | |
| 127596081 | 12759608 | 10 | 20131111 | 20131115 | 0 | |
| 127596081 | 12759608 | 11 | 20131216 | 20131220 | 0 | |
| 127596081 | 12759608 | 12 | 20140127 | 20140131 | 0 | |
| 127596081 | 12759608 | 13 | 20140303 | 20140307 | 0 | |
| 127596081 | 12759608 | 14 | 20140407 | 20140411 | 0 | |
| 127596081 | 12759608 | 19 | 20130115 | 0 | ||
| 127596081 | 12759608 | 20 | 20130729 | 0 | ||
| 127596081 | 12759608 | 21 | 20131226 | 0 | ||
| 127596081 | 12759608 | 22 | 20140206 | 0 | ||
| 127596081 | 12759608 | 23 | 20140228 | 20140305 | 0 | |
| 127596081 | 12759608 | 24 | 20140228 | 20140305 | 0 | |
| 127596081 | 12759608 | 25 | 20140417 | 20140426 | 0 | |
| 127596081 | 12759608 | 26 | 20140424 | 20140501 | 0 |