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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123612513 | 12361251 | 3 | F | 20150108 | 20160728 | 20160512 | 20160810 | EXP | US-ALEXION PHARMACEUTICALS INC-A201603373 | ALEXION | 25.00 | YR | F | Y | 81.90000 | KG | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123612513 | 12361251 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 123612513 | 12361251 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 123612513 | 12361251 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1500 MG, Q2W | 125166 | 1500 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 123612513 | 12361251 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE7318B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123612513 | 12361251 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE7318B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123612513 | 12361251 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE78946C01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123612513 | 12361251 | 7 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 20 MG, QD | Y | 0 | 20 | MG | TABLET | QD | |||||
| 123612513 | 12361251 | 8 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | 20 MG, Q2W | Y | 0 | 20 | MG | TABLET | QOW | |||||
| 123612513 | 12361251 | 9 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | 100 MG, BID | 0 | 100 | MG | BID | |||||||
| 123612513 | 12361251 | 10 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | 200 MG, BID | 0 | 200 | MG | BID | |||||||
| 123612513 | 12361251 | 11 | C | MULTIVITAMIN /07504101/ | VITAMINS | 1 | Oral | 1 TAB, QD | 0 | QD | |||||||||
| 123612513 | 12361251 | 12 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Oral | UNK | 0 | ||||||||||
| 123612513 | 12361251 | 13 | C | FOLVITE /00024201/ | 2 | Oral | 1 TAB, QD | 0 | QD | ||||||||||
| 123612513 | 12361251 | 14 | C | LEVORA-28 | 2 | Oral | 15-30 MG-MCG, UNK | 0 | |||||||||||
| 123612513 | 12361251 | 15 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | Oral | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 123612513 | 12361251 | 16 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 4 MG, UNK | 0 | 4 | MG | ||||||||
| 123612513 | 12361251 | 17 | C | EMLA | LIDOCAINEPRILOCAINE | 1 | Topical | UNK, PRN | 0 | /yr | |||||||||
| 123612513 | 12361251 | 18 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Oral | 1000 ?G, QD | 0 | 1000 | UG | QD | |||||||
| 123612513 | 12361251 | 19 | C | HEPARIN | HEPARIN SODIUM | 1 | Intravenous (not otherwise specified) | 500 UNITS, PRN | 0 | 500 | IU | /yr |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123612513 | 12361251 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 123612513 | 12361251 | 7 | Immunosuppression |
| 123612513 | 12361251 | 9 | Paroxysmal nocturnal haemoglobinuria |
| 123612513 | 12361251 | 11 | Product used for unknown indication |
| 123612513 | 12361251 | 12 | Product used for unknown indication |
| 123612513 | 12361251 | 13 | Product used for unknown indication |
| 123612513 | 12361251 | 14 | Product used for unknown indication |
| 123612513 | 12361251 | 15 | Product used for unknown indication |
| 123612513 | 12361251 | 16 | Product used for unknown indication |
| 123612513 | 12361251 | 17 | Pain |
| 123612513 | 12361251 | 18 | Product used for unknown indication |
| 123612513 | 12361251 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123612513 | 12361251 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123612513 | 12361251 | Alanine aminotransferase increased | |
| 123612513 | 12361251 | Anaemia | |
| 123612513 | 12361251 | Aplastic anaemia | |
| 123612513 | 12361251 | Aspartate aminotransferase increased | |
| 123612513 | 12361251 | Blood lactate dehydrogenase increased | |
| 123612513 | 12361251 | Condition aggravated | |
| 123612513 | 12361251 | Dizziness | |
| 123612513 | 12361251 | Drug intolerance | |
| 123612513 | 12361251 | Dyspnoea exertional | |
| 123612513 | 12361251 | Fatigue | |
| 123612513 | 12361251 | Full blood count abnormal | |
| 123612513 | 12361251 | Headache | |
| 123612513 | 12361251 | Incorrect dose administered | |
| 123612513 | 12361251 | Leukopenia | |
| 123612513 | 12361251 | Menorrhagia | |
| 123612513 | 12361251 | Nausea | |
| 123612513 | 12361251 | Serum ferritin increased | |
| 123612513 | 12361251 | Vitamin B12 deficiency |
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 |
|---|---|---|---|---|---|---|
| 123612513 | 12361251 | 1 | 20140612 | 0 | ||
| 123612513 | 12361251 | 9 | 201504 | 0 | ||
| 123612513 | 12361251 | 10 | 201602 | 0 |