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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116471138 | 11647113 | 8 | F | 20151012 | 20160725 | 20151021 | 20160802 | EXP | CA-ALEXION-A201504016 | ALEXION | 59.98 | YR | F | Y | 47.50000 | KG | 20160802 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116471138 | 11647113 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | AB7976C | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 116471138 | 11647113 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | AB7976C | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 116471138 | 11647113 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | AD6569B03 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 116471138 | 11647113 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | AD7698B01 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 116471138 | 11647113 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 116471138 | 11647113 | 6 | C | CALCITRIOL. | CALCITRIOL | 1 | Oral | 0.5 MG, TIW | 0 | .5 | MG | TIW | |||||||
| 116471138 | 11647113 | 7 | C | ARANESP | DARBEPOETIN ALFA | 1 | Oral | 100 MICROGRAMS, QW | 0 | /wk | |||||||||
| 116471138 | 11647113 | 8 | C | COLACE | DOCUSATE SODIUM | 1 | Oral | 1 TAB, PRN | 0 | /yr | |||||||||
| 116471138 | 11647113 | 9 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 1 MG, QD | 0 | 1 | MG | QD | |||||||
| 116471138 | 11647113 | 10 | C | HYDROMORPHONE | HYDROMORPHONE | 1 | Oral | 2-4 MG, PRN | 0 | /yr | |||||||||
| 116471138 | 11647113 | 11 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 1 MG, ON DIALYSIS DAYS | 0 | 1 | MG | ||||||||
| 116471138 | 11647113 | 12 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 12.5 MG, QHS | 0 | 12.5 | MG | QD | |||||||
| 116471138 | 11647113 | 13 | C | PANTOLOC /01263204/ | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 116471138 | 11647113 | 14 | C | IRON | IRON | 1 | Intravenous (not otherwise specified) | UNK, QW | 0 | /wk | |||||||||
| 116471138 | 11647113 | 15 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 500 MG, PRN | 0 | 500 | MG | /yr |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116471138 | 11647113 | 1 | Haemolytic uraemic syndrome |
| 116471138 | 11647113 | 5 | Hypertension |
| 116471138 | 11647113 | 6 | Vitamin supplementation |
| 116471138 | 11647113 | 7 | Anaemia |
| 116471138 | 11647113 | 8 | Laxative supportive care |
| 116471138 | 11647113 | 9 | Vitamin supplementation |
| 116471138 | 11647113 | 10 | Pain |
| 116471138 | 11647113 | 11 | Anxiety |
| 116471138 | 11647113 | 12 | Anxiety |
| 116471138 | 11647113 | 13 | Prophylaxis |
| 116471138 | 11647113 | 14 | Vitamin supplementation |
| 116471138 | 11647113 | 15 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116471138 | 11647113 | HO |
| 116471138 | 11647113 | OT |
| 116471138 | 11647113 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116471138 | 11647113 | Escherichia infection | |
| 116471138 | 11647113 | General physical health deterioration | |
| 116471138 | 11647113 | Heart rate increased | |
| 116471138 | 11647113 | Hypertension | |
| 116471138 | 11647113 | Ill-defined disorder | |
| 116471138 | 11647113 | Infection | |
| 116471138 | 11647113 | Lung infection | |
| 116471138 | 11647113 | Pleural effusion | |
| 116471138 | 11647113 | Pneumothorax | |
| 116471138 | 11647113 | Pyrexia | |
| 116471138 | 11647113 | Respiratory distress | |
| 116471138 | 11647113 | Sepsis | |
| 116471138 | 11647113 | Tachycardia | |
| 116471138 | 11647113 | Unresponsive to stimuli |
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 |
|---|---|---|---|---|---|---|
| 116471138 | 11647113 | 1 | 20141223 | 20150113 | 0 | |
| 116471138 | 11647113 | 2 | 20150120 | 0 | ||
| 116471138 | 11647113 | 3 | 20150120 | 0 | ||
| 116471138 | 11647113 | 4 | 20150120 | 0 | ||
| 116471138 | 11647113 | 5 | 20060101 | 0 | ||
| 116471138 | 11647113 | 6 | 20120101 | 0 | ||
| 116471138 | 11647113 | 7 | 20120101 | 0 | ||
| 116471138 | 11647113 | 8 | 20120101 | 0 | ||
| 116471138 | 11647113 | 9 | 20120101 | 0 | ||
| 116471138 | 11647113 | 10 | 20120101 | 0 | ||
| 116471138 | 11647113 | 11 | 20130201 | 0 | ||
| 116471138 | 11647113 | 12 | 20120101 | 0 | ||
| 116471138 | 11647113 | 13 | 20120101 | 0 | ||
| 116471138 | 11647113 | 14 | 20120101 | 0 | ||
| 116471138 | 11647113 | 15 | 20120101 | 0 |