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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126815462 | 12681546 | 2 | F | 20160907 | 20160824 | 20160914 | EXP | JP-SA-2016SA153425 | AVENTIS | MATSUSHITA Y, TAKATA Y, MATSUDA A, KAWAMURA R, ONUMA H, ONUMA H. A CASE OF TYPE 1 DIABETES WHOSE PROFILE OF AUTONOMIC NERVE ACTIVITY DURING NOCTURNAL HYPOGLYCEMIA WAS ANALYZED BY CONTINUOUS GLUCOSE MONITORING AND HOLTER ELECTROCARDIOGRAPHY. J JAPAN DIAB SOC. 2016 JUL;59(7):475-81. | 77.00 | YR | E | M | Y | 73.00000 | KG | 20160914 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126815462 | 12681546 | 1 | PS | INSULIN GLARGINE | INSULIN GLARGINE | 1 | Unknown | BRAEKFAST - 15U, DINNER-11U | U | UNK | 21081 | TID | |||||||
| 126815462 | 12681546 | 2 | SS | INSULIN GLARGINE | INSULIN GLARGINE | 1 | Unknown | BRAEKFAST - 12-13U, EVENING-6-8U | U | UNK | 21081 | TID | |||||||
| 126815462 | 12681546 | 3 | SS | INSULIN ASPART | INSULIN ASPART | 1 | Unknown | BEFORE EACH MEAL (BREAKFAST-16U,LUNCH-9U,DINNER-7U) | U | UNK | 0 | TID | |||||||
| 126815462 | 12681546 | 4 | SS | INSULIN ASPART | INSULIN ASPART | 1 | Unknown | BEFORE EACH MEAL (BREAKFAST-14U,LUNCH-4U,DINNER5-7U) | U | UNK | 0 | TID | |||||||
| 126815462 | 12681546 | 5 | C | VALSARTAN. | VALSARTAN | 1 | 40 MG IN 2 DIVIDED DOSES | 0 | 2 | DF | TABLET | ||||||||
| 126815462 | 12681546 | 6 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | 2 TABLETS IN A SINGLE DOSE | 0 | 2 | DF | TABLET | QD | |||||||
| 126815462 | 12681546 | 7 | C | EPALRESTAT | EPALRESTAT | 1 | 3 TABLETS IN 3 DIVIDED DOSES BEFORE EACH MEAL | 0 | 3 | DF | TABLET | TID | |||||||
| 126815462 | 12681546 | 8 | C | MOSAPRIDE CITRATE | MOSAPRIDE CITRATE | 1 | 3 TABLETS IN 3 DIVIDED DOSES AFTER EACH MEAL | 0 | 3 | DF | TABLET | ||||||||
| 126815462 | 12681546 | 9 | C | SENNOSIDE | SENNOSIDES | 1 | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126815462 | 12681546 | 1 | Type 1 diabetes mellitus |
| 126815462 | 12681546 | 2 | Type 1 diabetes mellitus |
| 126815462 | 12681546 | 3 | Type 1 diabetes mellitus |
| 126815462 | 12681546 | 4 | Type 1 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126815462 | 12681546 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126815462 | 12681546 | Autonomic nervous system imbalance | |
| 126815462 | 12681546 | Autonomic neuropathy | |
| 126815462 | 12681546 | Electrocardiogram QT prolonged | |
| 126815462 | 12681546 | Hypoglycaemia | |
| 126815462 | 12681546 | Sinus tachycardia | |
| 126815462 | 12681546 | Ventricular extrasystoles |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |