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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127785381 | 12778538 | 1 | I | 20160823 | 20160917 | 20160926 | 20160926 | EXP | CA-ALEXION PHARMACEUTICALS INC.-A201607061 | ALEXION | 40.44 | YR | M | Y | 93.00000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127785381 | 12778538 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | AE8437001 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 127785381 | 12778538 | 2 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 360 MG, BID | 0 | 360 | MG | BID | |||||||
| 127785381 | 12778538 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 127785381 | 12778538 | 4 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 127785381 | 12778538 | 5 | C | DOXAZOSIN | DOXAZOSINDOXAZOSIN MESYLATE | 1 | Oral | 8 MG, QHS | 0 | 8 | MG | QD | |||||||
| 127785381 | 12778538 | 6 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Oral | 25 MG, TID | 0 | 25 | MG | TID | |||||||
| 127785381 | 12778538 | 7 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 100 MG, BID | 0 | 100 | MG | BID | |||||||
| 127785381 | 12778538 | 8 | C | SEPTRA | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | 0 | ||||||||||
| 127785381 | 12778538 | 9 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 60 MG, BID | 0 | 60 | MG | BID | |||||||
| 127785381 | 12778538 | 10 | C | CALCITRIOL. | CALCITRIOL | 1 | Oral | 0.5 ?G, BID | 0 | .5 | UG | BID | |||||||
| 127785381 | 12778538 | 11 | C | ADVAGRAF | TACROLIMUS | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127785381 | 12778538 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 127785381 | 12778538 | 2 | Transplant rejection |
| 127785381 | 12778538 | 3 | Steroid therapy |
| 127785381 | 12778538 | 4 | Hypertension |
| 127785381 | 12778538 | 5 | Hypertension |
| 127785381 | 12778538 | 6 | Hypertension |
| 127785381 | 12778538 | 7 | Hypertension |
| 127785381 | 12778538 | 8 | Product used for unknown indication |
| 127785381 | 12778538 | 9 | Diuretic therapy |
| 127785381 | 12778538 | 10 | Product used for unknown indication |
| 127785381 | 12778538 | 11 | Transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127785381 | 12778538 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127785381 | 12778538 | Hypertension | |
| 127785381 | 12778538 | Inappropriate schedule of drug administration | |
| 127785381 | 12778538 | Incorrect dose administered | |
| 127785381 | 12778538 | Poor venous access |
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 |
|---|---|---|---|---|---|---|
| 127785381 | 12778538 | 1 | 20160823 | 0 |