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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126350653 | 12635065 | 3 | F | 201311 | 20160727 | 20160809 | 20160914 | PER | US-TEVA-680320USA | TEVA | 0.00 | M | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126350653 | 12635065 | 1 | PS | PROVIGIL | MODAFINIL | 1 | UNKNOWN | 20717 | 200 | MG | TABLET | ||||||||
| 126350653 | 12635065 | 2 | SS | PROVIGIL | MODAFINIL | 1 | UNKNOWN | 20717 | |||||||||||
| 126350653 | 12635065 | 3 | SS | NUVIGIL | ARMODAFINIL | 1 | Oral | 21875 | 150 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126350653 | 12635065 | 1 | Depressed level of consciousness |
| 126350653 | 12635065 | 2 | Disturbance in attention |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126350653 | 12635065 | Asthenia | |
| 126350653 | 12635065 | Disturbance in attention | |
| 126350653 | 12635065 | Drug ineffective | |
| 126350653 | 12635065 | Feeling abnormal | |
| 126350653 | 12635065 | Headache | |
| 126350653 | 12635065 | Incorrect dose administered | |
| 126350653 | 12635065 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 126350653 | 12635065 | 1 | 20131101 | 0 |