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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125294971 | 12529497 | 1 | I | 20111108 | 20160706 | 20160706 | EXP | DE-CIPLA LTD.-2011DE00211 | CIPLA | SCHUETTE W, NAGEL S, WEIKERSTHAL LFV, PABST S, SCHUMANN C, DEUSS B ET AL.,. RANDOMIZED PHASE III TRIAL OF DOCETAXEL PLUS CARBOPLATIN WITH OR WITHOUT LEVOFLOXACIN PROPHYLAXIS IN ELDERLY PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER THE APRONTA TRIAL. JOURNAL OF THORACIC ONCOLOGY. 2011;6 (12):2090 TO 2096 | 0.00 | Y | 0.00000 | 20160706 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125294971 | 12529497 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AREA UNDER THE CURVE 6, DAY 1, EVERY 3 WEEKS | U | U | 77383 | ||||||||
| 125294971 | 12529497 | 2 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 500 MG, ON DAY 5 TO 11, EVERY 3 WEEKS | U | U | 0 | 500 | MG | ||||||
| 125294971 | 12529497 | 3 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | U | U | 0 | ||||||||||
| 125294971 | 12529497 | 4 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous (not otherwise specified) | 75 MG/M2, DAY 1, EVERY 3 WEEKS | U | U | 0 | 75 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125294971 | 12529497 | 1 | Non-small cell lung cancer |
| 125294971 | 12529497 | 2 | Infection |
| 125294971 | 12529497 | 3 | Prophylaxis |
| 125294971 | 12529497 | 4 | Non-small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125294971 | 12529497 | OT |
| 125294971 | 12529497 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125294971 | 12529497 | Candida infection | |
| 125294971 | 12529497 | Pyrexia | |
| 125294971 | 12529497 | Urinary tract infection | |
| 125294971 | 12529497 | Urosepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |