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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123727103 | 12372710 | 3 | F | 20160408 | 20160829 | 20160516 | 20160901 | EXP | IT-ALEXION PHARMACEUTICALS INC.-A201603449 | ALEXION | 6.97 | MON | M | Y | 0.00000 | 20160901 | CN | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123727103 | 12372710 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | Y | U | 125166 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 123727103 | 12372710 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Y | U | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 123727103 | 12372710 | 3 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Unknown | 0 | |||||||||||
| 123727103 | 12372710 | 4 | C | CEFTRIAXONE. | CEFTRIAXONE | 1 | 0 | ||||||||||||
| 123727103 | 12372710 | 5 | C | CEFTRIAXONE. | CEFTRIAXONE | 1 | 0 | ||||||||||||
| 123727103 | 12372710 | 6 | C | CEFTRIAXONE. | CEFTRIAXONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123727103 | 12372710 | 1 | Haemolytic uraemic syndrome |
| 123727103 | 12372710 | 2 | Off label use |
| 123727103 | 12372710 | 3 | Bronchitis |
| 123727103 | 12372710 | 4 | Pyrexia |
| 123727103 | 12372710 | 5 | Vomiting |
| 123727103 | 12372710 | 6 | Diarrhoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123727103 | 12372710 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123727103 | 12372710 | Decreased appetite | |
| 123727103 | 12372710 | Hypokinesia | |
| 123727103 | 12372710 | Myoclonus | |
| 123727103 | 12372710 | Off label use | |
| 123727103 | 12372710 | Seizure | |
| 123727103 | 12372710 | Subdural haematoma |
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 |
|---|---|---|---|---|---|---|
| 123727103 | 12372710 | 1 | 20160408 | 20160416 | 0 |