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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126064541 | 12606454 | 1 | I | 20160629 | 20160725 | 20160729 | 20160729 | EXP | FR-AFSSAPS-NT20160866 | FR-GLAXOSMITHKLINE-FR2016GSK108887 | GLAXOSMITHKLINE | 56.20 | YR | M | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126064541 | 12606454 | 1 | PS | Wellvone | ATOVAQUONE | 1 | Oral | 1 UNK, BID | 12 | DF | Y | 20500 | 1 | DF | ORAL SUSPENSION | BID | |||
| 126064541 | 12606454 | 2 | SS | Rocephine | CEFTRIAXONE SODIUM | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 | |||||||||
| 126064541 | 12606454 | 3 | SS | Rocephine | CEFTRIAXONE SODIUM | 1 | Y | 0 | |||||||||||
| 126064541 | 12606454 | 4 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | 500 MG, TID | 9000 | MG | Y | 0 | 500 | MG | TABLET | TID | |||
| 126064541 | 12606454 | 5 | SS | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | 9000 | MG | Y | 0 | TABLET | ||||||||
| 126064541 | 12606454 | 6 | SS | ROVAMYCINE | SPIRAMYCIN | 1 | Intravenous (not otherwise specified) | 3 MILLION IU, TID | 54 | MIU | Y | 0 | 3 | MIU | TID | ||||
| 126064541 | 12606454 | 7 | SS | ZYVOXID | LINEZOLID | 1 | Oral | 600 MG, BID | 3600 | MG | Y | 0 | 600 | MG | BID | ||||
| 126064541 | 12606454 | 8 | SS | COLCHICINE. | COLCHICINE | 1 | Oral | UNK | Y | 0 | |||||||||
| 126064541 | 12606454 | 9 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | 180 MG, BID | 0 | 180 | MG | BID | ||||||||
| 126064541 | 12606454 | 10 | C | NEORAL | CYCLOSPORINE | 1 | 70 MG, BID | 0 | 70 | MG | BID | ||||||||
| 126064541 | 12606454 | 11 | C | ICAZ | ISRADIPINE | 1 | 5 MG, TID | 0 | 5 | MG | TID | ||||||||
| 126064541 | 12606454 | 12 | C | LASILIX | FUROSEMIDE | 1 | UNK | 0 | |||||||||||
| 126064541 | 12606454 | 13 | C | NEBIVOLOL. | NEBIVOLOL | 1 | 5 MG, 1D | 0 | 5 | MG | QD | ||||||||
| 126064541 | 12606454 | 14 | C | ARANESP | DARBEPOETIN ALFA | 1 | UNK | 0 | |||||||||||
| 126064541 | 12606454 | 15 | C | TARDYFERON | FERROUS SULFATE | 1 | 1 UNK, 1D | 0 | 1 | DF | QD | ||||||||
| 126064541 | 12606454 | 16 | C | UVEDOSE | CHOLECALCIFEROL | 1 | 100000 UNK, Z | 0 | 100000 | DF | |||||||||
| 126064541 | 12606454 | 17 | C | ZYLORIC | ALLOPURINOL | 1 | 300 MG, 1D | 0 | 300 | MG | QD | ||||||||
| 126064541 | 12606454 | 18 | C | PENTACARINAT | PENTAMIDINE ISETHIONATE | 1 | Respiratory (inhalation) | 300 MG, Z | 0 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126064541 | 12606454 | 1 | Antifungal prophylaxis |
| 126064541 | 12606454 | 2 | Pneumonia |
| 126064541 | 12606454 | 3 | Septic shock |
| 126064541 | 12606454 | 4 | Pneumonia |
| 126064541 | 12606454 | 5 | Septic shock |
| 126064541 | 12606454 | 6 | Pneumonia |
| 126064541 | 12606454 | 7 | Staphylococcal infection |
| 126064541 | 12606454 | 8 | Gout |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126064541 | 12606454 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126064541 | 12606454 | Mouth ulceration | |
| 126064541 | 12606454 | Rash |
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 |
|---|---|---|---|---|---|---|
| 126064541 | 12606454 | 1 | 20160623 | 20160704 | 0 | |
| 126064541 | 12606454 | 2 | 20160623 | 20160701 | 0 | |
| 126064541 | 12606454 | 4 | 20160623 | 20160630 | 0 | |
| 126064541 | 12606454 | 6 | 20160623 | 20160630 | 0 | |
| 126064541 | 12606454 | 7 | 20160626 | 20160630 | 0 | |
| 126064541 | 12606454 | 8 | 20160628 | 20160630 | 0 |