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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119285902 | 11928590 | 2 | F | 20160914 | 20160119 | 20160921 | EXP | GXBR2016US000500 | SANDOZ | 39.00 | YR | M | Y | 58.50000 | KG | 20160921 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119285902 | 11928590 | 1 | PS | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | AMOXICILLIN/CLAVULANATE 875/125MG BID | 65063 | 1 | DF | TABLET | BID | ||||||
| 119285902 | 11928590 | 2 | SS | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP | AMOXICILLINCLAVULANATE POTASSIUM | 1 | 65063 | TABLET | |||||||||||
| 119285902 | 11928590 | 3 | SS | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP | AMOXICILLINCLAVULANATE POTASSIUM | 1 | 65063 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119285902 | 11928590 | 1 | Crohn's disease |
| 119285902 | 11928590 | 2 | Gastrointestinal fistula |
| 119285902 | 11928590 | 3 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119285902 | 11928590 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119285902 | 11928590 | Abdominal pain upper | |
| 119285902 | 11928590 | Aphthous ulcer | |
| 119285902 | 11928590 | Coeliac disease | |
| 119285902 | 11928590 | Condition aggravated | |
| 119285902 | 11928590 | Feeling abnormal | |
| 119285902 | 11928590 | Gastrointestinal disorder | |
| 119285902 | 11928590 | Memory impairment | |
| 119285902 | 11928590 | Neuropathy peripheral | |
| 119285902 | 11928590 | Sensory loss | |
| 119285902 | 11928590 | Vitamin B complex deficiency |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |