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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122875033 | 12287503 | 3 | F | 20150820 | 20160915 | 20160420 | 20160923 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201602733 | ALEXION | 22.96 | YR | F | Y | 0.00000 | 20160923 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122875033 | 12287503 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | D | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 122875033 | 12287503 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | D | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 122875033 | 12287503 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | D | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122875033 | 12287503 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122875033 | 12287503 | DE |
| 122875033 | 12287503 | HO |
| 122875033 | 12287503 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122875033 | 12287503 | Abdominal pain | |
| 122875033 | 12287503 | Cardio-respiratory arrest | |
| 122875033 | 12287503 | Cerebrovascular accident | |
| 122875033 | 12287503 | Confusional state | |
| 122875033 | 12287503 | Contusion | |
| 122875033 | 12287503 | Diarrhoea | |
| 122875033 | 12287503 | Haemorrhage | |
| 122875033 | 12287503 | Incorrect dose administered | |
| 122875033 | 12287503 | Meningitis | |
| 122875033 | 12287503 | Pyrexia | |
| 122875033 | 12287503 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 122875033 | 12287503 | 1 | 20130419 | 20130509 | 0 | |
| 122875033 | 12287503 | 2 | 20130516 | 0 | ||
| 122875033 | 12287503 | 3 | 20150820 | 20160407 | 0 |