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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125385942 | 12538594 | 2 | F | 20160621 | 20160720 | 20160708 | 20160907 | PER | US-ALEXION-A201604950 | ALEXION | 73.00 | YR | M | Y | 103.86000 | KG | 20160907 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125385942 | 12538594 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 125385942 | 12538594 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 125385942 | 12538594 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 125385942 | 12538594 | 4 | C | CYCLOSPORIN | CYCLOSPORINE | 1 | Unknown | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 125385942 | 12538594 | 5 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | AS NEEDED | 0 | ||||||||||
| 125385942 | 12538594 | 6 | C | CHLORTHALIDONE. | CHLORTHALIDONE | 1 | Unknown | 0 | |||||||||||
| 125385942 | 12538594 | 7 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 125385942 | 12538594 | 8 | C | NAPROXEN. | NAPROXEN | 1 | Unknown | 500 MG, BID PRN | 0 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125385942 | 12538594 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 125385942 | 12538594 | 4 | Paroxysmal nocturnal haemoglobinuria |
| 125385942 | 12538594 | 5 | Product used for unknown indication |
| 125385942 | 12538594 | 6 | Product used for unknown indication |
| 125385942 | 12538594 | 7 | Product used for unknown indication |
| 125385942 | 12538594 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125385942 | 12538594 | Blood lactate dehydrogenase increased | |
| 125385942 | 12538594 | Drug ineffective | |
| 125385942 | 12538594 | Dysphagia | |
| 125385942 | 12538594 | Fatigue | |
| 125385942 | 12538594 | Haemoglobin 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 |
|---|---|---|---|---|---|---|
| 125385942 | 12538594 | 1 | 20160611 | 0 | ||
| 125385942 | 12538594 | 3 | 20160831 | 0 |