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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127456871 | 12745687 | 1 | I | 20160903 | 20160915 | 20160915 | EXP | JP-APOPHARMA USA, INC.-2016AP011796 | APOTEX | HAYASHI S, NAGAMINE S, MAKIOLA K, KUSUNOKI S, AND OKAMOTO K.. A CASE OF SEVERE CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY WITH MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE WITH ALTERNATING IMMUNOGLOBULIN CLASS TO IGM FROM IGA. RINSHO SHINKEIGAKU. 2016 | 71.00 | YR | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127456871 | 12745687 | 1 | PS | ALKERAN | MELPHALAN | 1 | Unknown | 5 MG, UNKNOWN | U | 999999 | 5 | MG | |||||||
| 127456871 | 12745687 | 2 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 32 MG, UNKNOWN | U | U | 0 | 32 | MG | ||||||
| 127456871 | 12745687 | 3 | C | IMMUNOGLOBULIN /00025201/ | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK UNK, UNKNOWN | U | 0 | |||||||||
| 127456871 | 12745687 | 4 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 12 MG, QD | U | 0 | 12 | MG | |||||||
| 127456871 | 12745687 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 15 MG, Q.WK. | U | 0 | 15 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127456871 | 12745687 | 1 | Chronic inflammatory demyelinating polyradiculoneuropathy |
| 127456871 | 12745687 | 2 | Chronic inflammatory demyelinating polyradiculoneuropathy |
| 127456871 | 12745687 | 3 | Chronic inflammatory demyelinating polyradiculoneuropathy |
| 127456871 | 12745687 | 5 | Chronic inflammatory demyelinating polyradiculoneuropathy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127456871 | 12745687 | OT |
| 127456871 | 12745687 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127456871 | 12745687 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 127456871 | 12745687 | 1 | 2009 | 2009 | 0 | |
| 127456871 | 12745687 | 2 | 2009 | 2009 | 0 | |
| 127456871 | 12745687 | 3 | 2009 | 2010 | 0 | |
| 127456871 | 12745687 | 4 | 2009 | 2009 | 0 | |
| 127456871 | 12745687 | 5 | 2009 | 2009 | 0 |