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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127503932 | 12750393 | 2 | F | 20160810 | 20160920 | 20160916 | 20160927 | EXP | TR-ALEXION PHARMACEUTICALS INC.-A201606765 | ALEXION | 44.34 | YR | M | Y | 70.00000 | KG | 20160927 | CN | TR | TR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127503932 | 12750393 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK, QW FOR 4 WEEKS | U | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||||
| 127503932 | 12750393 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK, Q2W | U | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||||
| 127503932 | 12750393 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||||
| 127503932 | 12750393 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | U | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 127503932 | 12750393 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | 300 MG, UNK | U | 125166 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 127503932 | 12750393 | 6 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 127503932 | 12750393 | 7 | C | LASIX | FUROSEMIDE | 1 | Oral | UNK, QD (1X1) | 0 | QD | |||||||||
| 127503932 | 12750393 | 8 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | UNK, 3X14 | 0 | ||||||||||
| 127503932 | 12750393 | 9 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | UNK,1X26 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127503932 | 12750393 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 127503932 | 12750393 | 6 | Hypertension |
| 127503932 | 12750393 | 7 | Hypertension |
| 127503932 | 12750393 | 8 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127503932 | 12750393 | LT |
| 127503932 | 12750393 | HO |
| 127503932 | 12750393 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127503932 | 12750393 | Blood lactate dehydrogenase increased | |
| 127503932 | 12750393 | Budd-Chiari syndrome | |
| 127503932 | 12750393 | Haemolysis | |
| 127503932 | 12750393 | Inappropriate schedule of drug administration | |
| 127503932 | 12750393 | Incorrect dose administered | |
| 127503932 | 12750393 | Renal impairment |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |