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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125668712 | 12566871 | 2 | F | 20160705 | 20160718 | 20160718 | 20160726 | PER | US-TAKEDA-2016TUS011995 | TAKEDA | 60.62 | YR | M | Y | 147.30000 | KG | 20160726 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125668712 | 12566871 | 1 | PS | TRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | Oral | 10 MG, QD | Y | UNKNOWN | 204447 | 10 | MG | TABLET | QD | ||||
| 125668712 | 12566871 | 2 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | UNK | 0 | QD | |||||||||
| 125668712 | 12566871 | 3 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 175 MG, QD | 0 | 175 | MG | QD | |||||||
| 125668712 | 12566871 | 4 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 10 MG, BID | U | 0 | 10 | MG | BID | ||||||
| 125668712 | 12566871 | 5 | C | LISINOPRIL HCTZ | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | Oral | UNK, QD | U | 0 | QD | ||||||||
| 125668712 | 12566871 | 6 | C | INVOKANA | CANAGLIFLOZIN | 1 | Oral | 300 MG, QD | U | 0 | 300 | MG | QD | ||||||
| 125668712 | 12566871 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 1000 MG, BID | U | 0 | 1000 | MG | BID | ||||||
| 125668712 | 12566871 | 8 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Oral | 81 MG, QD | U | 0 | 81 | MG | QD | ||||||
| 125668712 | 12566871 | 9 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG, QD | U | 0 | 300 | MG | QD | ||||||
| 125668712 | 12566871 | 10 | C | HUMALOG | INSULIN LISPRO | 1 | Other | UNK | U | 0 | INJECTION | ||||||||
| 125668712 | 12566871 | 11 | C | KRILL OIL | DIETARY SUPPLEMENT | 1 | Oral | UNK, QD | U | 0 | QD | ||||||||
| 125668712 | 12566871 | 12 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | Oral | 5000 MG, QD | U | 0 | 5000 | MG | QD | ||||||
| 125668712 | 12566871 | 13 | C | BYDUREON | EXENATIDE | 1 | Oral | 10 ?G, 1/WEEK | U | 0 | 10 | UG | /wk | ||||||
| 125668712 | 12566871 | 14 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 125668712 | 12566871 | 15 | C | TESTOSTERONE. | TESTOSTERONE | 1 | Topical | UNK, QD | U | 0 | GEL | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125668712 | 12566871 | 1 | Major depression |
| 125668712 | 12566871 | 2 | Anger |
| 125668712 | 12566871 | 4 | Impaired work ability |
| 125668712 | 12566871 | 5 | Hypertension |
| 125668712 | 12566871 | 6 | Type 2 diabetes mellitus |
| 125668712 | 12566871 | 7 | Type 2 diabetes mellitus |
| 125668712 | 12566871 | 9 | Neuropathy peripheral |
| 125668712 | 12566871 | 10 | Type 2 diabetes mellitus |
| 125668712 | 12566871 | 11 | Supplementation therapy |
| 125668712 | 12566871 | 12 | Supplementation therapy |
| 125668712 | 12566871 | 13 | Type 2 diabetes mellitus |
| 125668712 | 12566871 | 14 | High density lipoprotein decreased |
| 125668712 | 12566871 | 15 | Blood testosterone decreased |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125668712 | 12566871 | Agitation | |
| 125668712 | 12566871 | Anger | |
| 125668712 | 12566871 | Dizziness | |
| 125668712 | 12566871 | Gastric disorder | |
| 125668712 | 12566871 | Irritability | |
| 125668712 | 12566871 | Nausea | |
| 125668712 | 12566871 | Nightmare | |
| 125668712 | 12566871 | Sedation | |
| 125668712 | 12566871 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 125668712 | 12566871 | 1 | 20160622 | 20160706 | 0 |