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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126493935 | 12649393 | 5 | F | 2016 | 20160909 | 20160812 | 20160916 | EXP | CA-ALEXION-A201605263 | ALEXION | 46.26 | YR | M | Y | 83.90000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126493935 | 12649393 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 126493935 | 12649393 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 126493935 | 12649393 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q12D | AE1229B05 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 126493935 | 12649393 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q12D | AE7317B04 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 126493935 | 12649393 | 5 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Oral | 8 MG, PRN | U | 0 | 8 | MG | /yr | ||||||
| 126493935 | 12649393 | 6 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Subcutaneous | UNK, Q4H | U | 0 | Q4H | ||||||||
| 126493935 | 12649393 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 126493935 | 12649393 | 8 | C | PRADAX | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 150 MG, BID | 0 | 150 | MG | BID | |||||||
| 126493935 | 12649393 | 9 | C | MAGNESIUM | MAGNESIUM | 1 | Oral | UNK | 0 | ||||||||||
| 126493935 | 12649393 | 10 | C | POTASSIUM | POTASSIUM | 1 | Oral | UNK | 0 | ||||||||||
| 126493935 | 12649393 | 11 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 75 MG, QD | 0 | 75 | MG | QD | |||||||
| 126493935 | 12649393 | 12 | C | ADVIL | IBUPROFEN | 1 | Unknown | 0 | |||||||||||
| 126493935 | 12649393 | 13 | C | CALCIUM/VITAMIN D /01204201/ | CALCIUM CARBONATEERGOCALCIFEROL | 1 | Unknown | UNK | 0 | ||||||||||
| 126493935 | 12649393 | 14 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, FOR 7 DAYS | 0 | 20 | MG | ||||||||
| 126493935 | 12649393 | 15 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 10 MG, FOR 7 DAYS | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126493935 | 12649393 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 126493935 | 12649393 | 5 | Pain |
| 126493935 | 12649393 | 6 | Abdominal pain |
| 126493935 | 12649393 | 7 | Supplementation therapy |
| 126493935 | 12649393 | 8 | Anticoagulant therapy |
| 126493935 | 12649393 | 9 | Supplementation therapy |
| 126493935 | 12649393 | 10 | Supplementation therapy |
| 126493935 | 12649393 | 11 | Anxiety |
| 126493935 | 12649393 | 12 | Headache |
| 126493935 | 12649393 | 13 | Product used for unknown indication |
| 126493935 | 12649393 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126493935 | 12649393 | HO |
| 126493935 | 12649393 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126493935 | 12649393 | Abdominal pain | |
| 126493935 | 12649393 | Blood bilirubin increased | |
| 126493935 | 12649393 | Chromaturia | |
| 126493935 | 12649393 | Dizziness | |
| 126493935 | 12649393 | Dysphagia | |
| 126493935 | 12649393 | Haemoglobin decreased | |
| 126493935 | 12649393 | Hepatitis | |
| 126493935 | 12649393 | Malaise | |
| 126493935 | 12649393 | Scleral discolouration | |
| 126493935 | 12649393 | Vomiting | |
| 126493935 | 12649393 | Yellow skin |
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 |
|---|---|---|---|---|---|---|
| 126493935 | 12649393 | 1 | 20100409 | 20100428 | 0 | |
| 126493935 | 12649393 | 2 | 20100505 | 20150513 | 0 | |
| 126493935 | 12649393 | 3 | 20150513 | 0 | ||
| 126493935 | 12649393 | 4 | 20150513 | 0 | ||
| 126493935 | 12649393 | 8 | 20120501 | 0 | ||
| 126493935 | 12649393 | 9 | 20110901 | 0 | ||
| 126493935 | 12649393 | 10 | 20110901 | 0 | ||
| 126493935 | 12649393 | 11 | 20150309 | 0 | ||
| 126493935 | 12649393 | 13 | 201608 | 0 | ||
| 126493935 | 12649393 | 14 | 201608 | 0 |