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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127295462 | 12729546 | 2 | F | 201608 | 20160916 | 20160909 | 20160926 | PER | US-TAKEDA-2016TUS015769 | TAKEDA | 59.72 | YR | F | Y | 68.27000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127295462 | 12729546 | 1 | PS | ROZEREM | RAMELTEON | 1 | Oral | 8 MG, QD | Y | UNKNOWN | 21782 | 8 | MG | TABLET | QD | ||||
| 127295462 | 12729546 | 2 | SS | ROZEREM | RAMELTEON | 1 | Y | 21782 | TABLET | ||||||||||
| 127295462 | 12729546 | 3 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | UNK, QD | U | 0 | QD | ||||||||
| 127295462 | 12729546 | 4 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | U | 0 | |||||||||||
| 127295462 | 12729546 | 5 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | UNK, QD | U | 0 | QD | ||||||||
| 127295462 | 12729546 | 6 | C | DAILY MULTIVITAMIN | VITAMINS | 1 | Oral | UNK, QD | U | 0 | QD | ||||||||
| 127295462 | 12729546 | 7 | C | CALCIUM | CALCIUM | 1 | Oral | UNK UNK, QD | U | 0 | QD | ||||||||
| 127295462 | 12729546 | 8 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | UNK, QD | U | 0 | QD | ||||||||
| 127295462 | 12729546 | 9 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 200 MG, QD | U | 0 | 200 | MG | QD | |||||||
| 127295462 | 12729546 | 10 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 40 MG, QD | U | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127295462 | 12729546 | 1 | Sleep disorder |
| 127295462 | 12729546 | 2 | Insomnia |
| 127295462 | 12729546 | 3 | Gastrooesophageal reflux disease |
| 127295462 | 12729546 | 4 | Hernia |
| 127295462 | 12729546 | 5 | Depression |
| 127295462 | 12729546 | 6 | Supplementation therapy |
| 127295462 | 12729546 | 7 | Supplementation therapy |
| 127295462 | 12729546 | 8 | Supplementation therapy |
| 127295462 | 12729546 | 9 | Bipolar disorder |
| 127295462 | 12729546 | 10 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127295462 | 12729546 | Drug ineffective |
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 |
|---|---|---|---|---|---|---|
| 127295462 | 12729546 | 1 | 20160826 | 20160831 | 0 | |
| 127295462 | 12729546 | 9 | 2000 | 0 | ||
| 127295462 | 12729546 | 10 | 201606 | 0 |