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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127271321 | 12727132 | 1 | I | 20160721 | 20160909 | 20160909 | EXP | GB-ALEXION PHARMACEUTICALS INC.-A201605473 | ALEXION | 0.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127271321 | 12727132 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 127271321 | 12727132 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0005002 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 127271321 | 12727132 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | 900 MG, Q2W | P0005002 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 127271321 | 12727132 | 4 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | UNK | 0 | ||||||||||
| 127271321 | 12727132 | 5 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Oral | UNK | 0 | ||||||||||
| 127271321 | 12727132 | 6 | C | IRON | IRON | 1 | Oral | UNK | 0 | ||||||||||
| 127271321 | 12727132 | 7 | C | MAGNESIUM | MAGNESIUM | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127271321 | 12727132 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 127271321 | 12727132 | 4 | Product used for unknown indication |
| 127271321 | 12727132 | 5 | Product used for unknown indication |
| 127271321 | 12727132 | 6 | Product used for unknown indication |
| 127271321 | 12727132 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127271321 | 12727132 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127271321 | 12727132 | Abortion spontaneous | |
| 127271321 | 12727132 | Chest discomfort | |
| 127271321 | 12727132 | Exposure during pregnancy | |
| 127271321 | 12727132 | Fatigue | |
| 127271321 | 12727132 | Muscle strain | |
| 127271321 | 12727132 | Thirst |
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 |
|---|---|---|---|---|---|---|
| 127271321 | 12727132 | 1 | 20130821 | 20130912 | 0 | |
| 127271321 | 12727132 | 2 | 20130919 | 0 |