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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125413841 | 12541384 | 1 | I | 20160627 | 20160708 | 20160708 | EXP | CN-JNJFOC-20160626744 | JOHNSON AND JOHNSON | XIUYE F. COMPARATIVE STUDY OF IBUPROFEN, PARACETAMOL AND INDOMETACIN FOR THE TREATMENT OF PATENT DUCTUS ARTERIOSUS IN PREMATURE BABIES. YIYAO QIANYAN MAY-2015;5(15):75-76. | 0.00 | N | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125413841 | 12541384 | 1 | SS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | ANOTHER 2 DOSES WERE GIVEN RESPECTIVELY 24H AND 48H LATER AT 5 MG/KG EVERY TIME | U | U | 0 | 5 | MG/KG | UNSPECIFIED | |||||
| 125413841 | 12541384 | 2 | PS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | U | U | 19012 | 10 | MG/KG | UNSPECIFIED | ||||||
| 125413841 | 12541384 | 3 | SS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | ANOTHER 2 DOSES WERE GIVEN RESPECTIVELY 24H AND 48H LATER AT 5 MG/KG EVERY TIME | U | U | 19012 | 5 | MG/KG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125413841 | 12541384 | 1 | Patent ductus arteriosus |
| 125413841 | 12541384 | 2 | Patent ductus arteriosus |
| 125413841 | 12541384 | 3 | Patent ductus arteriosus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125413841 | 12541384 | HO |
| 125413841 | 12541384 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125413841 | 12541384 | Hyperbilirubinaemia | |
| 125413841 | 12541384 | Necrotising colitis | |
| 125413841 | 12541384 | Off label use | |
| 125413841 | 12541384 | Oliguria | |
| 125413841 | 12541384 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |