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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120853867 | 12085386 | 7 | F | 20121211 | 20160901 | 20160217 | 20160909 | EXP | GB-ALEXION PHARMACEUTICALS INC-A201600947 | ALEXION | 21.40 | YR | F | Y | 0.00000 | 20160909 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120853867 | 12085386 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0004202 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 120853867 | 12085386 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 120853867 | 12085386 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, SINGLE | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||||
| 120853867 | 12085386 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1500 MG, Q2W | 125166 | 1500 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 120853867 | 12085386 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1500 MG, Q2W | P0005002 | 125166 | 1500 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 120853867 | 12085386 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, UNK | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120853867 | 12085386 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120853867 | 12085386 | OT |
| 120853867 | 12085386 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120853867 | 12085386 | Abortion spontaneous | |
| 120853867 | 12085386 | Adverse event | |
| 120853867 | 12085386 | Exposure during pregnancy | |
| 120853867 | 12085386 | Fatigue | |
| 120853867 | 12085386 | Haemoglobin decreased | |
| 120853867 | 12085386 | Inappropriate schedule of drug administration | |
| 120853867 | 12085386 | Incorrect dose administered | |
| 120853867 | 12085386 | Premature separation of placenta | |
| 120853867 | 12085386 | Vaginal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 120853867 | 12085386 | 1 | 20081103 | 0 | ||
| 120853867 | 12085386 | 2 | 20121211 | 0 | ||
| 120853867 | 12085386 | 3 | 20160620 | 20160620 | 0 | |
| 120853867 | 12085386 | 4 | 20160626 | 0 | ||
| 120853867 | 12085386 | 5 | 20160626 | 20160902 | 0 | |
| 120853867 | 12085386 | 6 | 20160902 | 0 |