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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111753646 | 11175364 | 6 | F | 201505 | 20160708 | 20150609 | 20160715 | EXP | JP-ABBVIE-15K-087-1402261-00 | ABBVIE | 21.00 | YR | F | Y | 48.00000 | KG | 20160715 | MD | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111753646 | 11175364 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 111753646 | 11175364 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 111753646 | 11175364 | 3 | SS | VIDAZA | AZACITIDINE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 111753646 | 11175364 | 4 | SS | VIDAZA | AZACITIDINE | 1 | Y | UNKNOWN | 0 | ||||||||||
| 111753646 | 11175364 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | 0 | QD | |||||||||||
| 111753646 | 11175364 | 6 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 | QD | |||||||||||
| 111753646 | 11175364 | 7 | C | MESALAZINE | MESALAMINE | 1 | 0 | QD | |||||||||||
| 111753646 | 11175364 | 8 | C | COLCHICINE. | COLCHICINE | 1 | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111753646 | 11175364 | 1 | Behcet's syndrome |
| 111753646 | 11175364 | 3 | Myelodysplastic syndrome |
| 111753646 | 11175364 | 4 | Bone marrow failure |
| 111753646 | 11175364 | 5 | Product used for unknown indication |
| 111753646 | 11175364 | 6 | Product used for unknown indication |
| 111753646 | 11175364 | 7 | Product used for unknown indication |
| 111753646 | 11175364 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111753646 | 11175364 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111753646 | 11175364 | Bone marrow failure | |
| 111753646 | 11175364 | Neutrophil 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 |
|---|---|---|---|---|---|---|
| 111753646 | 11175364 | 1 | 20150430 | 20150430 | 0 | |
| 111753646 | 11175364 | 2 | 20150514 | 20150514 | 0 | |
| 111753646 | 11175364 | 3 | 20150429 | 20150503 | 0 | |
| 111753646 | 11175364 | 5 | 20150317 | 0 | ||
| 111753646 | 11175364 | 6 | 20150415 | 0 |