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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125682781 | 12568278 | 1 | I | 20160505 | 20160506 | 20160718 | 20160718 | PER | US-APOTEX-2016AP008357 | APOTEX | 89.76 | YR | F | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125682781 | 12568278 | 1 | PS | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | Transdermal | 25 MG, UNKNOWN | N | 44768 | 77449 | 25 | MG | TRANSDERMAL SYSTEM | |||||
| 125682781 | 12568278 | 2 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | 15 MG, QD | U | 0 | 15 | MG | |||||||
| 125682781 | 12568278 | 3 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Unknown | 100 MG, QD | U | 0 | 100 | MG | |||||||
| 125682781 | 12568278 | 4 | C | LOVASTATIN. | LOVASTATIN | 1 | Unknown | UNK UNK, UNKNOWN | U | 0 | |||||||||
| 125682781 | 12568278 | 5 | C | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | Unknown | UNK, UNKNOWN | U | 0 | |||||||||
| 125682781 | 12568278 | 6 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Unknown | 81 MG, QD | U | 0 | 81 | MG | |||||||
| 125682781 | 12568278 | 7 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | UNK, PRN | U | 0 | |||||||||
| 125682781 | 12568278 | 8 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | UNK, UNKNOWN | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125682781 | 12568278 | 1 | Product used for unknown indication |
| 125682781 | 12568278 | 2 | Product used for unknown indication |
| 125682781 | 12568278 | 3 | Product used for unknown indication |
| 125682781 | 12568278 | 4 | Product used for unknown indication |
| 125682781 | 12568278 | 5 | Blood cholesterol increased |
| 125682781 | 12568278 | 6 | Product used for unknown indication |
| 125682781 | 12568278 | 7 | Product used for unknown indication |
| 125682781 | 12568278 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125682781 | 12568278 | Product substitution issue | |
| 125682781 | 12568278 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 125682781 | 12568278 | 1 | 2016 | 20160505 | 0 |