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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124487863 | 12448786 | 3 | F | 201603 | 20160715 | 20160608 | 20160726 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201604068 | ALEXION | 28.85 | YR | F | Y | 0.00000 | 20160726 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124487863 | 12448786 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | P0004601 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 124487863 | 12448786 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | P0004601 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 124487863 | 12448786 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Oral | UNK | 0 | ||||||||||
| 124487863 | 12448786 | 4 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 124487863 | 12448786 | 5 | C | PEN-VE-ORAL | PENICILLIN V POTASSIUM | 1 | Oral | UNK | 0 | ||||||||||
| 124487863 | 12448786 | 6 | C | LORATADINE. | LORATADINE | 1 | Unknown | 0 | |||||||||||
| 124487863 | 12448786 | 7 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 0 | |||||||||||
| 124487863 | 12448786 | 8 | C | RANITIDINE. | RANITIDINE | 1 | 0 | ||||||||||||
| 124487863 | 12448786 | 9 | C | RANITIDINE. | RANITIDINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124487863 | 12448786 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 124487863 | 12448786 | 3 | Aplasia |
| 124487863 | 12448786 | 4 | Anticoagulant therapy |
| 124487863 | 12448786 | 5 | Infection prophylaxis |
| 124487863 | 12448786 | 6 | Product used for unknown indication |
| 124487863 | 12448786 | 7 | Hypersensitivity |
| 124487863 | 12448786 | 8 | Pruritus generalised |
| 124487863 | 12448786 | 9 | Dysphonia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124487863 | 12448786 | OT |
| 124487863 | 12448786 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124487863 | 12448786 | Abdominal pain | |
| 124487863 | 12448786 | Abortion | |
| 124487863 | 12448786 | Allergic cough | |
| 124487863 | 12448786 | Cough | |
| 124487863 | 12448786 | Drug hypersensitivity | |
| 124487863 | 12448786 | Dysphonia | |
| 124487863 | 12448786 | Haemoglobinuria | |
| 124487863 | 12448786 | Haemolysis | |
| 124487863 | 12448786 | Hepatic vascular thrombosis | |
| 124487863 | 12448786 | Hypersensitivity | |
| 124487863 | 12448786 | Pruritus generalised | |
| 124487863 | 12448786 | Skin lesion | |
| 124487863 | 12448786 | Thrombosis | |
| 124487863 | 12448786 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124487863 | 12448786 | 1 | 20141105 | 20141226 | 0 |