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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123763142 | 12376314 | 2 | F | 20160317 | 20160630 | 20160517 | 20160711 | EXP | US-ALEXION PHARMACEUTICALS INC-A201603477 | ALEXION | 13.80 | YR | M | Y | 0.00000 | 20160711 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123763142 | 12376314 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, EVERY 28 DAYS | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 123763142 | 12376314 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW FOR 5 DOSES | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 123763142 | 12376314 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, FOR 1 WEEK | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 123763142 | 12376314 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 123763142 | 12376314 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | QE1225B01 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 123763142 | 12376314 | 6 | C | PEPCID | FAMOTIDINE | 1 | Oral | 10 MG, BID | 0 | 10 | MG | BID | |||||||
| 123763142 | 12376314 | 7 | C | PENICILLIN /00000901/ | PENICILLIN G | 1 | Oral | 250 MG, BID | 0 | 250 | MG | BID | |||||||
| 123763142 | 12376314 | 8 | C | IRON | IRON | 1 | Oral | 65 MG, DAILY | 0 | 65 | MG | ||||||||
| 123763142 | 12376314 | 9 | C | FOLATE | FOLATE SODIUM | 1 | Oral | 0 | |||||||||||
| 123763142 | 12376314 | 10 | C | FOLATE | FOLATE SODIUM | 1 | 0 | ||||||||||||
| 123763142 | 12376314 | 11 | C | FISH OIL | FISH OIL | 1 | Oral | 0 | |||||||||||
| 123763142 | 12376314 | 12 | C | FISH OIL | FISH OIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123763142 | 12376314 | 1 | Haemolytic uraemic syndrome |
| 123763142 | 12376314 | 6 | Gastrooesophageal reflux disease |
| 123763142 | 12376314 | 7 | Infection prophylaxis |
| 123763142 | 12376314 | 8 | Supplementation therapy |
| 123763142 | 12376314 | 9 | Supplementation therapy |
| 123763142 | 12376314 | 10 | Attention deficit/hyperactivity disorder |
| 123763142 | 12376314 | 11 | Supplementation therapy |
| 123763142 | 12376314 | 12 | Attention deficit/hyperactivity disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123763142 | 12376314 | HO |
| 123763142 | 12376314 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123763142 | 12376314 | Cerebrospinal fluid leakage | |
| 123763142 | 12376314 | Headache | |
| 123763142 | 12376314 | Inappropriate schedule of drug administration | |
| 123763142 | 12376314 | Pyrexia | |
| 123763142 | 12376314 | Thrombotic microangiopathy |
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 |
|---|---|---|---|---|---|---|
| 123763142 | 12376314 | 2 | 20160317 | 0 | ||
| 123763142 | 12376314 | 5 | 20160506 | 0 |