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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126022513 | 12602251 | 3 | F | 2016 | 20160808 | 20160728 | 20160815 | EXP | US-SA-2016SA136001 | AVENTIS | 54.00 | YR | A | F | Y | 0.00000 | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126022513 | 12602251 | 1 | PS | PRALUENT | ALIROCUMAB | 1 | Unknown | Y | 5F015A | 125559 | 75 | MG | INJECTION | QOW | |||||
| 126022513 | 12602251 | 2 | SS | PRALUENT | ALIROCUMAB | 1 | Unknown | Y | 6F035A | 125559 | 75 | MG | INJECTION | QOW | |||||
| 126022513 | 12602251 | 3 | SS | LITHIUM. | LITHIUM | 1 | Unknown | U | UNK | 0 | 3 | DF | TABLET | QD | |||||
| 126022513 | 12602251 | 4 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | U | UNK | 0 | QD | ||||||||
| 126022513 | 12602251 | 5 | C | ALIROCUMAB PREFILLED PEN | ALIROCUMAB | 1 | 0 | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126022513 | 12602251 | 1 | Blood cholesterol increased |
| 126022513 | 12602251 | 2 | Blood cholesterol increased |
| 126022513 | 12602251 | 3 | Bipolar disorder |
| 126022513 | 12602251 | 4 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126022513 | 12602251 | DS |
| 126022513 | 12602251 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126022513 | 12602251 | Anaemia | |
| 126022513 | 12602251 | Blood creatinine increased | |
| 126022513 | 12602251 | Blood potassium abnormal | |
| 126022513 | 12602251 | Blood urea increased | |
| 126022513 | 12602251 | Cardiac disorder | |
| 126022513 | 12602251 | Diarrhoea | |
| 126022513 | 12602251 | End stage renal disease | |
| 126022513 | 12602251 | Haemoglobin decreased | |
| 126022513 | 12602251 | Immune system disorder | |
| 126022513 | 12602251 | Laboratory test abnormal | |
| 126022513 | 12602251 | Malaise | |
| 126022513 | 12602251 | Peripheral swelling | |
| 126022513 | 12602251 | Polyp |
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 |
|---|---|---|---|---|---|---|
| 126022513 | 12602251 | 1 | 20160423 | 20160507 | 0 | |
| 126022513 | 12602251 | 2 | 20160423 | 20160507 | 0 | |
| 126022513 | 12602251 | 3 | 1986 | 201605 | 0 | |
| 126022513 | 12602251 | 4 | 1986 | 0 | ||
| 126022513 | 12602251 | 5 | 20160423 | 20160521 | 0 |