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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125486102 | 12548610 | 2 | F | 201606 | 20160916 | 20160712 | 20160923 | EXP | CA-ALEXION PHARMACEUTICALS INC-A201605045 | ALEXION | 24.59 | YR | M | Y | 72.57000 | KG | 20160923 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125486102 | 12548610 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 125486102 | 12548610 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE4703B03 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125486102 | 12548610 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE8437C01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 125486102 | 12548610 | 4 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | Oral | 800 IU, QD | 0 | 800 | IU | QD | |||||||
| 125486102 | 12548610 | 5 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | Unknown | 0.2-0.3 MG, PRN | 0 | /yr | |||||||||
| 125486102 | 12548610 | 6 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 1000 ?G, QMONTH | 0 | 1000 | UG | INJECTION | /month | ||||||
| 125486102 | 12548610 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 125486102 | 12548610 | 8 | C | BENYLIN DM /00000402/ | 2 | Oral | UNK, PRN | 0 | /yr | ||||||||||
| 125486102 | 12548610 | 9 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 500 MG, PRN, PRE MEDICATION FOR SOLIRIS | 0 | 500 | MG | /yr | |||||||
| 125486102 | 12548610 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | UNK | 0 | /yr | |||||||||
| 125486102 | 12548610 | 11 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 25 MG, PRN | 0 | 25 | MG | /yr | |||||||
| 125486102 | 12548610 | 12 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | Oral | 50 MG, UNK | 0 | 50 | MG | ||||||||
| 125486102 | 12548610 | 13 | C | BIPHENTIN | METHYLPHENIDATE | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 125486102 | 12548610 | 14 | C | NOVO-CLONIDINE | 2 | Oral | 0.25 MG, UNK | 0 | .25 | MG | |||||||||
| 125486102 | 12548610 | 15 | C | PMS-CLONAZEPAM | CLONAZEPAM | 1 | Oral | 0.25 MG, UNK | 0 | .25 | MG | ||||||||
| 125486102 | 12548610 | 16 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 60 MG, BID | 0 | 60 | MG | BID | |||||||
| 125486102 | 12548610 | 17 | C | FUCIDIN /00065701/ | 2 | Unknown | UNK, QID | 0 | CREAM | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125486102 | 12548610 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 125486102 | 12548610 | 4 | Supplementation therapy |
| 125486102 | 12548610 | 5 | Chest pain |
| 125486102 | 12548610 | 6 | Vitamin B12 deficiency |
| 125486102 | 12548610 | 7 | Supplementation therapy |
| 125486102 | 12548610 | 8 | Nasopharyngitis |
| 125486102 | 12548610 | 9 | Headache |
| 125486102 | 12548610 | 11 | Product used for unknown indication |
| 125486102 | 12548610 | 12 | Depression |
| 125486102 | 12548610 | 13 | Autism spectrum disorder |
| 125486102 | 12548610 | 14 | Product used for unknown indication |
| 125486102 | 12548610 | 15 | Product used for unknown indication |
| 125486102 | 12548610 | 16 | Depression |
| 125486102 | 12548610 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125486102 | 12548610 | HO |
| 125486102 | 12548610 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125486102 | 12548610 | Cytogenetic analysis abnormal | |
| 125486102 | 12548610 | Drug ineffective | |
| 125486102 | 12548610 | Myelodysplastic syndrome | |
| 125486102 | 12548610 | Platelet count 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 |
|---|---|---|---|---|---|---|
| 125486102 | 12548610 | 1 | 20090819 | 20090909 | 0 | |
| 125486102 | 12548610 | 2 | 20090916 | 0 | ||
| 125486102 | 12548610 | 3 | 20090916 | 0 | ||
| 125486102 | 12548610 | 8 | 201206 | 0 | ||
| 125486102 | 12548610 | 9 | 2009 | 0 | ||
| 125486102 | 12548610 | 11 | 2009 | 0 | ||
| 125486102 | 12548610 | 12 | 2013 | 0 | ||
| 125486102 | 12548610 | 13 | 201308 | 0 | ||
| 125486102 | 12548610 | 14 | 201308 | 0 | ||
| 125486102 | 12548610 | 15 | 201308 | 0 | ||
| 125486102 | 12548610 | 16 | 201404 | 0 | ||
| 125486102 | 12548610 | 17 | 20140730 | 0 |