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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123195354 | 12319535 | 4 | F | 20160218 | 20160830 | 20160429 | 20160909 | EXP | JP-ALEXION PHARMACEUTICALS INC-A201602914 | ALEXION | 82.00 | YR | M | Y | 58.00000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123195354 | 12319535 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 6000 | MG | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
| 123195354 | 12319535 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 6000 | MG | AE3116D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||
| 123195354 | 12319535 | 3 | C | FOLIAMIN | FOLIC ACID | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 123195354 | 12319535 | 4 | C | SUNRYTHM | PILSICAINIDE HYDROCHLORIDE | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | CAPSULE | |||||||
| 123195354 | 12319535 | 5 | C | PRAZAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG, UNK | 0 | 220 | MG | CAPSULE | |||||||
| 123195354 | 12319535 | 6 | C | URIEF | SILODOSIN | 1 | Oral | 4 MG, UNK | 0 | 4 | MG | TABLET | |||||||
| 123195354 | 12319535 | 7 | C | ARTIST | CARVEDILOL | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | TABLET | |||||||
| 123195354 | 12319535 | 8 | C | OLOPATADINE HYDROCHLORIDE. | OLOPATADINE HYDROCHLORIDE | 1 | Oral | 2 DF, UNK | 0 | TABLET | |||||||||
| 123195354 | 12319535 | 9 | C | EXJADE | DEFERASIROX | 1 | Oral | 1000 MG, UNK | 0 | 1000 | MG | ||||||||
| 123195354 | 12319535 | 10 | C | SENNARIDE | SENNOSIDES A AND B | 1 | Oral | 24 MG, UNK | 0 | 24 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123195354 | 12319535 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 123195354 | 12319535 | 3 | Product used for unknown indication |
| 123195354 | 12319535 | 4 | Product used for unknown indication |
| 123195354 | 12319535 | 5 | Product used for unknown indication |
| 123195354 | 12319535 | 6 | Product used for unknown indication |
| 123195354 | 12319535 | 7 | Product used for unknown indication |
| 123195354 | 12319535 | 8 | Product used for unknown indication |
| 123195354 | 12319535 | 9 | Product used for unknown indication |
| 123195354 | 12319535 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123195354 | 12319535 | OT |
| 123195354 | 12319535 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123195354 | 12319535 | Death | |
| 123195354 | 12319535 | Drug ineffective | |
| 123195354 | 12319535 | Liver abscess | |
| 123195354 | 12319535 | Pulmonary mycosis |
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 |
|---|---|---|---|---|---|---|
| 123195354 | 12319535 | 1 | 20160112 | 20160204 | 0 | |
| 123195354 | 12319535 | 2 | 20160212 | 20160408 | 0 | |
| 123195354 | 12319535 | 3 | 20120420 | 0 |