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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123305513 | 12330551 | 3 | F | 20150330 | 20160816 | 20160504 | 20160826 | EXP | DE-ALEXION PHARMACEUTICALS INC-A201603167 | ALEXION | 41.00 | YR | M | Y | 0.00000 | 20160826 | CN | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123305513 | 12330551 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW FOR FIVE WEEKS | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 123305513 | 12330551 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123305513 | 12330551 | 3 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | UNK | 0 | ||||||||||
| 123305513 | 12330551 | 4 | C | BOSENTAN. | BOSENTAN | 1 | Unknown | 31.25 MG, BID | 0 | 31.25 | MG | BID | |||||||
| 123305513 | 12330551 | 5 | C | BOSENTAN. | BOSENTAN | 1 | 125 MG, QD | 0 | 125 | MG | QD | ||||||||
| 123305513 | 12330551 | 6 | C | AMLODIPIN /00972401/ | AMLODIPINE BESYLATE | 1 | Unknown | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 123305513 | 12330551 | 7 | C | TORASEMIDE | TORSEMIDE | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 123305513 | 12330551 | 8 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | 12.5 MG, UNK | 0 | 12.5 | MG | ||||||||
| 123305513 | 12330551 | 9 | C | CANDESARTAN | CANDESARTAN | 1 | Unknown | 8 MG, QD | 0 | 8 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123305513 | 12330551 | 1 | Malignant hypertension |
| 123305513 | 12330551 | 2 | Off label use |
| 123305513 | 12330551 | 3 | Prophylaxis |
| 123305513 | 12330551 | 4 | Malignant hypertension |
| 123305513 | 12330551 | 6 | Hypertension |
| 123305513 | 12330551 | 7 | Hypertension |
| 123305513 | 12330551 | 8 | Hypertension |
| 123305513 | 12330551 | 9 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123305513 | 12330551 | HO |
| 123305513 | 12330551 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123305513 | 12330551 | H1N1 influenza | |
| 123305513 | 12330551 | Meningococcal bacteraemia | |
| 123305513 | 12330551 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 123305513 | 12330551 | 1 | 20150330 | 0 | ||
| 123305513 | 12330551 | 3 | 20150330 | 20150414 | 0 |