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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117462164 | 11746216 | 4 | F | 20151102 | 20160805 | 20151117 | 20160816 | EXP | PHHO2015ZA018880 | SANDOZ | 59.53 | YR | F | Y | 85.00000 | KG | 20160816 | MD | ZA | ZA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117462164 | 11746216 | 1 | PS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 850 MG, BID | 75985 | 850 | MG | BID | |||||||
| 117462164 | 11746216 | 2 | SS | ENALAPRIL | ENALAPRIL | 1 | Oral | 10 MG, BID | 0 | 10 | MG | BID | |||||||
| 117462164 | 11746216 | 3 | SS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 117462164 | 11746216 | 4 | SS | LASIX | FUROSEMIDE | 1 | Unknown | 0 | |||||||||||
| 117462164 | 11746216 | 5 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 117462164 | 11746216 | 6 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 117462164 | 11746216 | 7 | SS | BLINDED RLX030 | SERELAXIN | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 117462164 | 11746216 | 8 | C | INSULIN | INSULIN NOS | 1 | Unknown | 4 U, UNK | 0 | 4 | DF | ||||||||
| 117462164 | 11746216 | 9 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 40 MG, QD | Y | 0 | 40 | MG | QD | ||||||
| 117462164 | 11746216 | 10 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 20 MG, UNK | Y | 0 | 20 | MG | |||||||
| 117462164 | 11746216 | 11 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 80 MG, BID | U | 0 | 80 | MG | BID | ||||||
| 117462164 | 11746216 | 12 | C | ENALAPRIL | ENALAPRIL | 1 | Oral | 10 MG, BID | U | 0 | 10 | MG | BID | ||||||
| 117462164 | 11746216 | 13 | C | CARLOC | CARVEDILOL | 1 | Oral | 6.25 MG, BID | U | 0 | 6.25 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117462164 | 11746216 | 1 | Diabetes mellitus |
| 117462164 | 11746216 | 2 | Product used for unknown indication |
| 117462164 | 11746216 | 3 | Product used for unknown indication |
| 117462164 | 11746216 | 4 | Product used for unknown indication |
| 117462164 | 11746216 | 5 | Cardiac failure acute |
| 117462164 | 11746216 | 6 | Cardiac failure acute |
| 117462164 | 11746216 | 7 | Cardiac failure acute |
| 117462164 | 11746216 | 8 | Diabetes mellitus |
| 117462164 | 11746216 | 9 | Prophylaxis |
| 117462164 | 11746216 | 11 | Product used for unknown indication |
| 117462164 | 11746216 | 12 | Product used for unknown indication |
| 117462164 | 11746216 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117462164 | 11746216 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117462164 | 11746216 | Acute kidney injury | |
| 117462164 | 11746216 | Hypotension | |
| 117462164 | 11746216 | Liver injury | |
| 117462164 | 11746216 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 117462164 | 11746216 | 1 | 20150818 | 0 | ||
| 117462164 | 11746216 | 2 | 20151101 | 0 | ||
| 117462164 | 11746216 | 3 | 20151101 | 0 | ||
| 117462164 | 11746216 | 4 | 20151101 | 0 | ||
| 117462164 | 11746216 | 5 | 20151029 | 20151031 | 0 | |
| 117462164 | 11746216 | 6 | 20151029 | 20151031 | 0 | |
| 117462164 | 11746216 | 7 | 20151029 | 20151031 | 0 | |
| 117462164 | 11746216 | 8 | 20151103 | 0 | ||
| 117462164 | 11746216 | 9 | 20151029 | 0 | ||
| 117462164 | 11746216 | 10 | 20151102 | 0 |