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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 79365662 | 7936566 | 2 | F | 20101112 | 20130823 | 20110509 | 20130930 | PER | US-ALEXION-A201001464 | ALEXION | 16.16 | YR | F | Y | 0.00000 | 20130930 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 79365662 | 7936566 | 1 | PS | SOLIRIS | 1 | INTRAVENOUS | 600 MG, QW | D | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 79365662 | 7936566 | 2 | SS | SOLIRIS | 1 | INTRAVENOUS | 900 MG, Q2W | D | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 79365662 | 7936566 | 3 | C | COUMADIN /00014802/ | 1 | UNK | D | 0 | |||||||||||
| 79365662 | 7936566 | 4 | C | LITHIUM | 1 | UNK | D | 0 | |||||||||||
| 79365662 | 7936566 | 5 | C | ZOLOFT /01011401/ | 1 | UNK | D | 0 | |||||||||||
| 79365662 | 7936566 | 6 | C | VITAMIN B12 /00056201/ | 2 | UNK | D | 0 | |||||||||||
| 79365662 | 7936566 | 7 | C | MULTIVITAMIN /00831701/ | 2 | UNK | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 79365662 | 7936566 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 79365662 | 7936566 | 2 | Off label use |
| 79365662 | 7936566 | 3 | Anticoagulant therapy |
| 79365662 | 7936566 | 4 | Bipolar disorder |
| 79365662 | 7936566 | 5 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 79365662 | 7936566 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 79365662 | 7936566 | Haematocrit decreased | |
| 79365662 | 7936566 | Headache | |
| 79365662 | 7936566 | International normalised ratio increased | |
| 79365662 | 7936566 | Nausea | |
| 79365662 | 7936566 | Pain | |
| 79365662 | 7936566 | Pyrexia | |
| 79365662 | 7936566 | 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 |
|---|---|---|---|---|---|---|
| 79365662 | 7936566 | 1 | 20100416 | 201006 | 0 | |
| 79365662 | 7936566 | 2 | 201006 | 0 |