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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125489101 | 12548910 | 1 | I | 20160426 | 20160630 | 20160712 | 20160712 | EXP | AU-JNJFOC-20160702550 | JANSSEN | 69.86 | YR | E | M | Y | 0.00000 | 20160712 | MD | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125489101 | 12548910 | 1 | PS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | N | 204042 | 100 | MG | CAPSULE | QD | ||||||
| 125489101 | 12548910 | 2 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | N | 119255 | 100 | MG | CAPSULE | QD | ||||||
| 125489101 | 12548910 | 3 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 1 | G | CAPSULE | QID | |||||||
| 125489101 | 12548910 | 4 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | 150 | MG | UNSPECIFIED | QD | |||||||
| 125489101 | 12548910 | 5 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 1000 | MG | UNSPECIFIED | BID | |||||||
| 125489101 | 12548910 | 6 | C | IRBESARTAN. | IRBESARTAN | 1 | Oral | 0 | 150 | MG | UNSPECIFIED | QD | |||||||
| 125489101 | 12548910 | 7 | C | IRBESARTAN. | IRBESARTAN | 1 | Oral | 0 | 150 | MG | UNSPECIFIED | QD | |||||||
| 125489101 | 12548910 | 8 | C | DOCUSATE SODIUM AND SENNA | DOCUSATE SODIUMSENNOSIDES | 1 | Oral | 2 TEASPOON | 0 | UNSPECIFIED | |||||||||
| 125489101 | 12548910 | 9 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 125489101 | 12548910 | 10 | C | OXYCODONE | OXYCODONE | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | ||||||||
| 125489101 | 12548910 | 11 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Oral | 0 | 2.5 | MG | UNSPECIFIED | QD | |||||||
| 125489101 | 12548910 | 12 | C | INSULIN ASPART | INSULIN ASPART | 1 | Subcutaneous | 0 | 30 | IU | UNSPECIFIED | TID | |||||||
| 125489101 | 12548910 | 13 | C | INSULIN GLARGINE | INSULIN GLARGINE | 1 | Subcutaneous | 0 | 96 | IU | UNSPECIFIED | ||||||||
| 125489101 | 12548910 | 14 | C | INSULIN GLARGINE | INSULIN GLARGINE | 1 | Subcutaneous | 0 | 34 | IU | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125489101 | 12548910 | 1 | Diabetic nephropathy |
| 125489101 | 12548910 | 2 | Type 2 diabetes mellitus |
| 125489101 | 12548910 | 3 | Benign prostatic hyperplasia |
| 125489101 | 12548910 | 4 | Prophylaxis |
| 125489101 | 12548910 | 5 | Type 2 diabetes mellitus |
| 125489101 | 12548910 | 6 | Hypertension |
| 125489101 | 12548910 | 7 | Hypertension |
| 125489101 | 12548910 | 8 | Benign prostatic hyperplasia |
| 125489101 | 12548910 | 9 | Benign prostatic hyperplasia |
| 125489101 | 12548910 | 10 | Benign prostatic hyperplasia |
| 125489101 | 12548910 | 11 | Hypertension |
| 125489101 | 12548910 | 12 | Type 2 diabetes mellitus |
| 125489101 | 12548910 | 13 | Diabetes mellitus |
| 125489101 | 12548910 | 14 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125489101 | 12548910 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125489101 | 12548910 | Acute kidney injury | |
| 125489101 | 12548910 | Prostatitis |
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 |
|---|---|---|---|---|---|---|
| 125489101 | 12548910 | 1 | 20150316 | 0 | ||
| 125489101 | 12548910 | 2 | 20150316 | 0 | ||
| 125489101 | 12548910 | 3 | 20150929 | 0 | ||
| 125489101 | 12548910 | 4 | 2010 | 0 | ||
| 125489101 | 12548910 | 5 | 20150519 | 0 | ||
| 125489101 | 12548910 | 6 | 2008 | 20150518 | 0 | |
| 125489101 | 12548910 | 7 | 20150522 | 0 | ||
| 125489101 | 12548910 | 8 | 20150929 | 0 | ||
| 125489101 | 12548910 | 9 | 20150929 | 0 | ||
| 125489101 | 12548910 | 10 | 20150929 | 0 | ||
| 125489101 | 12548910 | 11 | 20150522 | 0 | ||
| 125489101 | 12548910 | 12 | 20150520 | 0 | ||
| 125489101 | 12548910 | 13 | 20150330 | 0 | ||
| 125489101 | 12548910 | 14 | 20150330 | 0 |