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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125464025 | 12546402 | 5 | F | 2016 | 20160916 | 20160711 | 20160928 | EXP | CA-ALEXION-A201605011 | ALEXION | 64.92 | YR | F | Y | 48.53000 | KG | 20160928 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125464025 | 12546402 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | D | A802736 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
| 125464025 | 12546402 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | D | 00015A | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 125464025 | 12546402 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | D | AE4703B03 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 125464025 | 12546402 | 4 | C | NEORAL | CYCLOSPORINE | 1 | Oral | 200 MG, BID | 0 | 200 | MG | BID | |||||||
| 125464025 | 12546402 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 125464025 | 12546402 | 6 | C | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 125464025 | 12546402 | 7 | C | CILOXAN | CIPROFLOXACIN HYDROCHLORIDE | 1 | Ophthalmic | ONE APPLICATION , BOTH EYESX 2 MONTH | 0 | OINTMENT, CREAM | |||||||||
| 125464025 | 12546402 | 8 | C | CYCLOSPORIN | CYCLOSPORINE | 1 | Oral | 300 MG, BID | 0 | 300 | MG | BID | |||||||
| 125464025 | 12546402 | 9 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | 500 MG, TID | 0 | 500 | MG | TID | |||||||
| 125464025 | 12546402 | 10 | C | NEUPOGEN | FILGRASTIM | 1 | Unknown | UNK, TWICE A WEEK | 0 | ||||||||||
| 125464025 | 12546402 | 11 | C | EPREX | ERYTHROPOIETIN | 1 | Unknown | UNK, QW | 0 | /wk | |||||||||
| 125464025 | 12546402 | 12 | C | REVOLADE | ELTROMBOPAG | 1 | Unknown | 75 MG, QD | 0 | 75 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125464025 | 12546402 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 125464025 | 12546402 | 4 | Immunosuppressant drug therapy |
| 125464025 | 12546402 | 5 | Hypertension |
| 125464025 | 12546402 | 6 | Depression |
| 125464025 | 12546402 | 7 | Eye inflammation |
| 125464025 | 12546402 | 8 | Prophylaxis |
| 125464025 | 12546402 | 9 | Noninfective gingivitis |
| 125464025 | 12546402 | 10 | Product used for unknown indication |
| 125464025 | 12546402 | 11 | Anaemia |
| 125464025 | 12546402 | 12 | Platelet disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125464025 | 12546402 | DE |
| 125464025 | 12546402 | OT |
| 125464025 | 12546402 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125464025 | 12546402 | Aplastic anaemia | |
| 125464025 | 12546402 | Arthralgia | |
| 125464025 | 12546402 | Asthenia | |
| 125464025 | 12546402 | Blood pressure increased | |
| 125464025 | 12546402 | Condition aggravated | |
| 125464025 | 12546402 | Confusional state | |
| 125464025 | 12546402 | Eye swelling | |
| 125464025 | 12546402 | Fluid retention | |
| 125464025 | 12546402 | General physical health deterioration | |
| 125464025 | 12546402 | Haemoglobin decreased | |
| 125464025 | 12546402 | Haemorrhage | |
| 125464025 | 12546402 | Headache | |
| 125464025 | 12546402 | Inappropriate schedule of drug administration | |
| 125464025 | 12546402 | Malaise | |
| 125464025 | 12546402 | Ocular hyperaemia | |
| 125464025 | 12546402 | Oedema peripheral | |
| 125464025 | 12546402 | Pancytopenia | |
| 125464025 | 12546402 | Paroxysmal nocturnal haemoglobinuria | |
| 125464025 | 12546402 | Platelet count decreased | |
| 125464025 | 12546402 | Poor quality sleep | |
| 125464025 | 12546402 | Pyrexia | |
| 125464025 | 12546402 | Retinal vein thrombosis | |
| 125464025 | 12546402 | Speech disorder | |
| 125464025 | 12546402 | Staphylococcal abscess | |
| 125464025 | 12546402 | Thrombosis | |
| 125464025 | 12546402 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125464025 | 12546402 | 1 | 20130523 | 20130613 | 0 | |
| 125464025 | 12546402 | 2 | 20130620 | 0 | ||
| 125464025 | 12546402 | 3 | 20130620 | 20160715 | 0 | |
| 125464025 | 12546402 | 4 | 20150921 | 0 | ||
| 125464025 | 12546402 | 5 | 20130417 | 0 | ||
| 125464025 | 12546402 | 6 | 20130402 | 0 | ||
| 125464025 | 12546402 | 7 | 20131105 | 0 | ||
| 125464025 | 12546402 | 8 | 20160215 | 0 | ||
| 125464025 | 12546402 | 9 | 20151203 | 0 | ||
| 125464025 | 12546402 | 10 | 20160314 | 0 | ||
| 125464025 | 12546402 | 11 | 20160314 | 0 | ||
| 125464025 | 12546402 | 12 | 20160525 | 0 |