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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126534181 | 12653418 | 1 | I | 201607 | 20160805 | 20160815 | 20160815 | PER | US-ALEXION-A201605836 | ALEXION | 58.62 | YR | M | Y | 79.83000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126534181 | 12653418 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 126534181 | 12653418 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 126534181 | 12653418 | 3 | C | CIPROFLOXACIN /00697202/ | CIPROFLOXACIN HYDROCHLORIDE | 1 | Oral | 500 MG, Q12H FOR 7 DAYS | 0 | 500 | MG | TABLET | Q12H | ||||||
| 126534181 | 12653418 | 4 | C | FOLVITE /00024201/ | 2 | Oral | FOR 30 DAYS | 0 | TABLET | QD | |||||||||
| 126534181 | 12653418 | 5 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Oral | 325 MG, TID | 0 | 325 | MG | TABLET | TID | ||||||
| 126534181 | 12653418 | 6 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | Oral | 1 ?G, QD | 0 | 1 | UG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126534181 | 12653418 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 126534181 | 12653418 | 3 | Prophylaxis |
| 126534181 | 12653418 | 4 | Paroxysmal nocturnal haemoglobinuria |
| 126534181 | 12653418 | 5 | Paroxysmal nocturnal haemoglobinuria |
| 126534181 | 12653418 | 6 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126534181 | 12653418 | Abdominal pain | |
| 126534181 | 12653418 | Adverse event | |
| 126534181 | 12653418 | Chromaturia | |
| 126534181 | 12653418 | Headache | |
| 126534181 | 12653418 | Hypoaesthesia | |
| 126534181 | 12653418 | Inappropriate schedule of drug administration | |
| 126534181 | 12653418 | Infection | |
| 126534181 | 12653418 | Paraesthesia | |
| 126534181 | 12653418 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 126534181 | 12653418 | 1 | 20160217 | 0 | ||
| 126534181 | 12653418 | 2 | 20160315 | 0 |