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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120984765 | 12098476 | 5 | F | 20160208 | 20160705 | 20160222 | 20160713 | EXP | KR-ALEXION PHARMACEUTICALS INC.-A201601098 | ALEXION | 72.50 | YR | M | Y | 58.50000 | KG | 20160713 | CN | KR | KR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120984765 | 12098476 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | Y | AD6569B09 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
| 120984765 | 12098476 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | AD6569B09 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 120984765 | 12098476 | 3 | C | RABIET | 2 | Oral | 10 MG, UNK | 0 | 10 | MG | |||||||||
| 120984765 | 12098476 | 4 | C | MUCOSTA | REBAMIPIDE | 1 | Oral | 200 MG, UNK | 0 | 200 | MG | ||||||||
| 120984765 | 12098476 | 5 | C | FOLSAN | FOLIC ACID | 1 | Oral | 4 MG, UNK | 0 | 4 | MG | ||||||||
| 120984765 | 12098476 | 6 | C | EXJADE | DEFERASIROX | 1 | Oral | 250 MG, UNK | 0 | 250 | MG | ||||||||
| 120984765 | 12098476 | 7 | C | ASPIRIN PROTECT | ASPIRIN | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 120984765 | 12098476 | 8 | C | CILOSTAN | 2 | Oral | 200 MG, UNK | 0 | 200 | MG | |||||||||
| 120984765 | 12098476 | 9 | C | NEUROMED /00943401/ | 2 | Oral | 1600 MG, UNK | 0 | 1600 | MG | |||||||||
| 120984765 | 12098476 | 10 | C | URSA | 2 | Oral | 300 MG, UNK | 0 | 300 | MG | |||||||||
| 120984765 | 12098476 | 11 | C | LEGALON | MILK THISTLE | 1 | Oral | 420 MG, UNK | 0 | 420 | MG | CAPSULE | |||||||
| 120984765 | 12098476 | 12 | C | CALCORT | DEFLAZACORT | 1 | Oral | 9 MG, UNK | 0 | 9 | MG | ||||||||
| 120984765 | 12098476 | 13 | C | ULTRACET | ACETAMINOPHENTRAMADOL HYDROCHLORIDE | 1 | Oral | 1450 MG, UNK | 0 | 1450 | MG | ||||||||
| 120984765 | 12098476 | 14 | C | PHENIRAMIN | 2 | Intravenous (not otherwise specified) | 4 MG, UNK | 0 | 4 | MG | |||||||||
| 120984765 | 12098476 | 15 | C | CORTISOLU | HYDROCORTISONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 50 MG, UNK | 0 | 50 | MG | ||||||||
| 120984765 | 12098476 | 16 | C | CRAVIT | LEVOFLOXACIN | 1 | Oral | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 120984765 | 12098476 | 17 | C | CRAVIT | LEVOFLOXACIN | 1 | Unknown | 500 MG, QD | 0 | 500 | MG | QD | |||||||
| 120984765 | 12098476 | 18 | C | GODEX | 2 | Oral | 1450 MG, UNK | 0 | 1450 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120984765 | 12098476 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 120984765 | 12098476 | 3 | Prophylaxis against gastrointestinal ulcer |
| 120984765 | 12098476 | 4 | Prophylaxis against gastrointestinal ulcer |
| 120984765 | 12098476 | 5 | Anaemia |
| 120984765 | 12098476 | 6 | Haemosiderosis |
| 120984765 | 12098476 | 7 | Cerebral infarction |
| 120984765 | 12098476 | 8 | Cerebral infarction |
| 120984765 | 12098476 | 9 | Cerebral infarction |
| 120984765 | 12098476 | 10 | Hepatic function abnormal |
| 120984765 | 12098476 | 11 | Hepatic function abnormal |
| 120984765 | 12098476 | 12 | Paroxysmal nocturnal haemoglobinuria |
| 120984765 | 12098476 | 13 | Arthralgia |
| 120984765 | 12098476 | 14 | Prophylaxis |
| 120984765 | 12098476 | 15 | Prophylaxis |
| 120984765 | 12098476 | 16 | Infection prophylaxis |
| 120984765 | 12098476 | 18 | Arthralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120984765 | 12098476 | OT |
| 120984765 | 12098476 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120984765 | 12098476 | C-reactive protein increased | |
| 120984765 | 12098476 | Enterocolitis | |
| 120984765 | 12098476 | Gastrointestinal haemorrhage | |
| 120984765 | 12098476 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 120984765 | 12098476 | 1 | 20160108 | 20160129 | 0 | |
| 120984765 | 12098476 | 2 | 20160205 | 0 | ||
| 120984765 | 12098476 | 3 | 20151012 | 0 | ||
| 120984765 | 12098476 | 4 | 20130108 | 0 | ||
| 120984765 | 12098476 | 5 | 20130107 | 0 | ||
| 120984765 | 12098476 | 6 | 20150930 | 0 | ||
| 120984765 | 12098476 | 7 | 20151030 | 20160229 | 0 | |
| 120984765 | 12098476 | 8 | 20151030 | 20160229 | 0 | |
| 120984765 | 12098476 | 9 | 20150908 | 0 | ||
| 120984765 | 12098476 | 10 | 20151211 | 20160229 | 0 | |
| 120984765 | 12098476 | 11 | 20150507 | 20160229 | 0 | |
| 120984765 | 12098476 | 12 | 20130121 | 20160229 | 0 | |
| 120984765 | 12098476 | 13 | 20160205 | 0 | ||
| 120984765 | 12098476 | 14 | 20160205 | 20160205 | 0 | |
| 120984765 | 12098476 | 15 | 20160205 | 20160205 | 0 | |
| 120984765 | 12098476 | 16 | 20160419 | 20160424 | 0 | |
| 120984765 | 12098476 | 17 | 20160627 | 20160703 | 0 | |
| 120984765 | 12098476 | 18 | 20160205 | 0 |