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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115112709 | 11511270 | 9 | F | 201412 | 20160630 | 20150915 | 20160708 | PER | US-TAKEDA-2015TUS012428 | TAKEDA | 53.20 | YR | F | Y | 68.27000 | KG | 20160708 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115112709 | 11511270 | 1 | PS | ACTOS | PIOGLITAZONE HYDROCHLORIDE | 1 | Oral | 30 MG, QD | N | 21073 | 30 | MG | QD | ||||||
| 115112709 | 11511270 | 2 | SS | ACTOS | PIOGLITAZONE HYDROCHLORIDE | 1 | Oral | 15 MG, QD | N | 21073 | 15 | MG | QD | ||||||
| 115112709 | 11511270 | 3 | SS | ACTOS | PIOGLITAZONE HYDROCHLORIDE | 1 | Oral | 15 MG, QD | N | 21073 | 15 | MG | QD | ||||||
| 115112709 | 11511270 | 4 | SS | PIOGLITAZONE. | PIOGLITAZONE | 1 | Oral | UNK, QD | N | 21073 | QD | ||||||||
| 115112709 | 11511270 | 5 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 5 MG, UNK | U | 0 | 5 | MG | TABLET | ||||||
| 115112709 | 11511270 | 6 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | TABLET | QD | |||||
| 115112709 | 11511270 | 7 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Oral | 81 MG, QD | U | 0 | 81 | MG | TABLET | QD | |||||
| 115112709 | 11511270 | 8 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 850 MG, BID | U | 0 | 850 | MG | TABLET | BID | |||||
| 115112709 | 11511270 | 9 | C | GLIPIZIDE. | GLIPIZIDE | 1 | Oral | 10 MG, BID | U | 0 | 10 | MG | TABLET | BID | |||||
| 115112709 | 11511270 | 10 | C | LOPID | GEMFIBROZIL | 1 | Oral | 600 MG, BID | U | 0 | 600 | MG | TABLET | BID | |||||
| 115112709 | 11511270 | 11 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | 50 MG, QD | U | 0 | 50 | MG | TABLET | QD | |||||
| 115112709 | 11511270 | 12 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 108 ?G, UNK | U | 0 | 108 | UG | |||||||
| 115112709 | 11511270 | 13 | C | VICODIN ES | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | UNK, TID | U | 0 | TABLET | TID | |||||||
| 115112709 | 11511270 | 14 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 800 MG, TID | U | 0 | 800 | MG | TABLET | TID | |||||
| 115112709 | 11511270 | 15 | C | DICLOFENAC SODIUM. | DICLOFENAC SODIUM | 1 | Oral | 75 MG, BID | U | 0 | 75 | MG | TABLET | BID | |||||
| 115112709 | 11511270 | 16 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | UNK, BID | U | 0 | BID | ||||||||
| 115112709 | 11511270 | 17 | C | MOBIC | MELOXICAM | 1 | Oral | 15 MG, QD | U | 0 | 15 | MG | QD | ||||||
| 115112709 | 11511270 | 18 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | Oral | 50 MG, Q8HR | U | 0 | 50 | MG | Q8H | ||||||
| 115112709 | 11511270 | 19 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | 500 MG, BID | U | 0 | 500 | MG | BID | ||||||
| 115112709 | 11511270 | 20 | C | LOTRIMIN /00212501/ | 2 | Topical | UNK, BID | U | 0 | BID | |||||||||
| 115112709 | 11511270 | 21 | C | BUFFERIN | ASPIRIN | 1 | Oral | 81 MG, QD | U | 0 | 81 | MG | QD | ||||||
| 115112709 | 11511270 | 22 | C | CEPHAXIN | 2 | U | 0 | ||||||||||||
| 115112709 | 11511270 | 23 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK, BID | U | 0 | BID | ||||||||
| 115112709 | 11511270 | 24 | C | NYSTATIN. | NYSTATIN | 1 | Topical | UNK, BID | U | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115112709 | 11511270 | 1 | Type 2 diabetes mellitus |
| 115112709 | 11511270 | 4 | Type 2 diabetes mellitus |
| 115112709 | 11511270 | 5 | Prophylaxis |
| 115112709 | 11511270 | 7 | Cardiovascular event prophylaxis |
| 115112709 | 11511270 | 8 | Diabetes mellitus |
| 115112709 | 11511270 | 9 | Diabetes mellitus |
| 115112709 | 11511270 | 12 | Dyspnoea |
| 115112709 | 11511270 | 13 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115112709 | 11511270 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115112709 | 11511270 | Abdominal discomfort | |
| 115112709 | 11511270 | Anxiety | |
| 115112709 | 11511270 | Asthma | |
| 115112709 | 11511270 | Bacterial vaginosis | |
| 115112709 | 11511270 | Bladder neoplasm | |
| 115112709 | 11511270 | Bladder pain | |
| 115112709 | 11511270 | Breast cyst | |
| 115112709 | 11511270 | Carpal tunnel syndrome | |
| 115112709 | 11511270 | Chromaturia | |
| 115112709 | 11511270 | Essential hypertension | |
| 115112709 | 11511270 | Fungal infection | |
| 115112709 | 11511270 | Micturition disorder | |
| 115112709 | 11511270 | Myalgia | |
| 115112709 | 11511270 | Myositis | |
| 115112709 | 11511270 | Pain | |
| 115112709 | 11511270 | Pollakiuria | |
| 115112709 | 11511270 | Skin lesion | |
| 115112709 | 11511270 | Spinal fusion surgery | |
| 115112709 | 11511270 | Trichomoniasis | |
| 115112709 | 11511270 | Vaginal infection | |
| 115112709 | 11511270 | Vulvovaginal discomfort | |
| 115112709 | 11511270 | Vulvovaginitis trichomonal |
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 |
|---|---|---|---|---|---|---|
| 115112709 | 11511270 | 1 | 2009 | 0 | ||
| 115112709 | 11511270 | 2 | 20130912 | 20140319 | 0 | |
| 115112709 | 11511270 | 3 | 20140319 | 20140319 | 0 | |
| 115112709 | 11511270 | 4 | 201402 | 201408 | 0 | |
| 115112709 | 11511270 | 5 | 2006 | 0 | ||
| 115112709 | 11511270 | 7 | 1998 | 0 | ||
| 115112709 | 11511270 | 8 | 1998 | 0 | ||
| 115112709 | 11511270 | 9 | 1998 | 0 | ||
| 115112709 | 11511270 | 16 | 20130912 | 0 | ||
| 115112709 | 11511270 | 17 | 20130912 | 0 | ||
| 115112709 | 11511270 | 18 | 20130912 | 0 | ||
| 115112709 | 11511270 | 21 | 20140319 | 0 | ||
| 115112709 | 11511270 | 23 | 20140319 | 0 |