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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123123794 | 12312379 | 4 | F | 20150511 | 20160624 | 20160428 | 20160701 | EXP | JP-ALXN-A201603018AA | ALEXION | 54.00 | YR | M | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123123794 | 12312379 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | AC6839D01 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 123123794 | 12312379 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AD7700B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123123794 | 12312379 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE3116D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123123794 | 12312379 | 4 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 5 MG, DAILY | 0 | 5 | MG | ||||||||
| 123123794 | 12312379 | 5 | C | TANATRIL | IMIDAPRIL | 1 | Unknown | 5 MG, DAILY | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123123794 | 12312379 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 123123794 | 12312379 | 4 | Product used for unknown indication |
| 123123794 | 12312379 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123123794 | 12312379 | OT |
| 123123794 | 12312379 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123123794 | 12312379 | Blood lactate dehydrogenase increased | |
| 123123794 | 12312379 | Enterocolitis | |
| 123123794 | 12312379 | Haemolysis | |
| 123123794 | 12312379 | Pancreatitis acute |
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 |
|---|---|---|---|---|---|---|
| 123123794 | 12312379 | 1 | 20150401 | 20150423 | 0 | |
| 123123794 | 12312379 | 2 | 20150511 | 0 |