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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127228941 | 12722894 | 1 | I | 20160824 | 20160907 | 20160907 | EXP | CN-JNJFOC-20160904746 | JOHNSON AND JOHNSON | BO Y, XIANG-YU G, XIU-LI W, XIANG-JUN C. CLINICAL COMPARISON STUDY OF ORAL IBUPROFEN ON NEONATAL PATENT DUCTUS ARTERIOSUS. CHINESE JOURNAL OF OBSTETRICS + GYNECOLOGY AND PEDIATRICS APR-2013;9(2):155-161. | 0.00 | N | M | Y | 1.10000 | KG | 20160907 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127228941 | 12722894 | 1 | PS | IBUPROFEN. | IBUPROFEN | 1 | Nasal | U | 20516 | SUSPENSION | |||||||||
| 127228941 | 12722894 | 2 | SS | IBUPROFEN. | IBUPROFEN | 1 | Nasal | (WITH MINIMAL NASAL FEEDING OF PRETERM FORMULA AT THAT TIME) | U | 20516 | SUSPENSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127228941 | 12722894 | 2 | Patent ductus arteriosus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127228941 | 12722894 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127228941 | 12722894 | Drug ineffective for unapproved indication | |
| 127228941 | 12722894 | Off label use | |
| 127228941 | 12722894 | Product use issue | |
| 127228941 | 12722894 | Upper gastrointestinal haemorrhage |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |