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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120468096 | 12046809 | 6 | F | 20160105 | 20160912 | 20160209 | 20160920 | EXP | FR-JNJFOC-20160202247 | JOHNSON AND JOHNSON | 67.22 | YR | E | M | Y | 0.00000 | 20160920 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120468096 | 12046809 | 1 | PS | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | Y | N | UNKNOWN | 19487 | UNSPECIFIED | |||||||
| 120468096 | 12046809 | 2 | SS | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | ADMINISTERED AFTER EACH WATERY STOOLWITHDRAWN BETWEEN 05-JAN-2016 TO 13-JAN-2016 | Y | N | UNKNOWN | 19487 | UNSPECIFIED | ||||||
| 120468096 | 12046809 | 3 | SS | TEMODAL | TEMOZOLOMIDE | 1 | Oral | 17TH COURSE | Y | 0 | UNSPECIFIED | ||||||||
| 120468096 | 12046809 | 4 | SS | TEMODAL | TEMOZOLOMIDE | 1 | Oral | 16TH COURSE | Y | 0 | UNSPECIFIED | ||||||||
| 120468096 | 12046809 | 5 | SS | TEMODAL | TEMOZOLOMIDE | 1 | Oral | ADMINISTERED DURING 5 DAYS | Y | 0 | 60 | MG | UNSPECIFIED | ||||||
| 120468096 | 12046809 | 6 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 120468096 | 12046809 | 7 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 20 | MG | TABLETS | TID | |||||||
| 120468096 | 12046809 | 8 | SS | ZOPHREN | ONDANSETRON | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 120468096 | 12046809 | 9 | SS | PHLOROGLUCINOL | PHLOROGLUCINOL | 1 | Oral | 0 | 80 | MG | TABLET | TID | |||||||
| 120468096 | 12046809 | 10 | SS | SMECTA | MONTMORILLONITE | 1 | Oral | ADMINISTERED AT NOON??WITHDRAWN BETWEEN 05-JAN-2016 TO13-JAN-2016 | Y | 0 | UNSPECIFIED | ||||||||
| 120468096 | 12046809 | 11 | SS | SMECTA | MONTMORILLONITE | 1 | Oral | Y | 0 | UNSPECIFIED | |||||||||
| 120468096 | 12046809 | 12 | SS | ROCEPHINE | CEFTRIAXONE SODIUM | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 120468096 | 12046809 | 13 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 120468096 | 12046809 | 14 | C | DIFFU K | POTASSIUM CHLORIDE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120468096 | 12046809 | 15 | C | INEXIUM | ESOMEPRAZOLE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120468096 | 12046809 | 16 | C | LERCAN | LERCANIDIPINE | 1 | Unknown | D | 0 | UNSPECIFIED | |||||||||
| 120468096 | 12046809 | 17 | C | INEGY | EZETIMIBESIMVASTATIN | 1 | Unknown | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120468096 | 12046809 | 2 | Diarrhoea |
| 120468096 | 12046809 | 3 | Glioblastoma |
| 120468096 | 12046809 | 4 | Glioblastoma |
| 120468096 | 12046809 | 5 | Glioblastoma |
| 120468096 | 12046809 | 6 | Product used for unknown indication |
| 120468096 | 12046809 | 7 | Product used for unknown indication |
| 120468096 | 12046809 | 8 | Vomiting |
| 120468096 | 12046809 | 9 | Gastrointestinal disorder |
| 120468096 | 12046809 | 10 | Gastrointestinal disorder |
| 120468096 | 12046809 | 11 | Gastrointestinal disorder |
| 120468096 | 12046809 | 12 | Diarrhoea |
| 120468096 | 12046809 | 13 | Diarrhoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120468096 | 12046809 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120468096 | 12046809 | Drug ineffective | |
| 120468096 | 12046809 | Gastrointestinal disorder | |
| 120468096 | 12046809 | Intussusception |
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 |
|---|---|---|---|---|---|---|
| 120468096 | 12046809 | 2 | 20151222 | 201601 | 0 | |
| 120468096 | 12046809 | 3 | 20151222 | 20160202 | 0 | |
| 120468096 | 12046809 | 4 | 20151024 | 0 | ||
| 120468096 | 12046809 | 5 | 20140522 | 0 | ||
| 120468096 | 12046809 | 9 | 20151222 | 0 | ||
| 120468096 | 12046809 | 10 | 20151222 | 201601 | 0 | |
| 120468096 | 12046809 | 11 | 2016 | 0 | ||
| 120468096 | 12046809 | 12 | 20160119 | 0 | ||
| 120468096 | 12046809 | 13 | 20160119 | 0 |