Trial · NCT01459653
Outcomes93
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 93
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Chemotherapy Toxicity (%FN Risk) | Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data. Please refer to baseline characteristics tables as well. | participants | NUMBER |
| PRIMARY | Cancer Treatment Type - Ever Received During Study | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data). | participants | NUMBER |
| PRIMARY | Fever and Infections Ever During the Study | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data). | participants | NUMBER |
| PRIMARY | Clinical Events Ever During Study (Frequency Threshold: 5%) | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) | participants | NUMBER |
| PRIMARY | Type of EP2006 Prophylaxis | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | Delayed Primary: EP2006 initiated in cycle 2 or later with no CIN/FN in prior cycle.~True secondary: EP2006 initiated in cycle 2 or later following CIN/FN in prior cycle. | participants | NUMBER |
| PRIMARY | Type of EP2006 Prophylaxis by Gender | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | Evaluable sample by gender | participants | NUMBER |
| PRIMARY | Type of EP 2006 Prophylaxis by Age Group | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | Evaluable sample by age | participants | NUMBER |
| PRIMARY | Type of EP 2006 Prophylaxis by Tumor Type | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | Evaluable sample by tumor type | participants | NUMBER |
| PRIMARY | Concomitant Antibiotic Prophylaxis | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | participants | NUMBER | |
| PRIMARY | EP2006 Dose (All Cycles) | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | All cycles from patients in the evaluable sample | cycles | NUMBER |
| PRIMARY | EP2006 Dose (Enrollment Cycle) | Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | Number of participants at enrollment cycle with dose data | participants | NUMBER |
| PRIMARY | EP2006 Dose (Cycle 1) | Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | Number of participants at cycle 1 with dose data | participants | NUMBER |
| PRIMARY | EP2006 Dose (Cycle 2) | Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | Number of participants at cycle 2 with dose data | participants | NUMBER |
| PRIMARY | EP2006 Dose (Cycle 3) | Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | Number of participants at cycle 3 with dose data | participants | NUMBER |
| PRIMARY | EP2006 Dose (Cycle 4) | Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | Number of participants at cycle 4 with dose data | participants | NUMBER |
| PRIMARY | EP2006 Dose (Cycle 5) | Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | Number of participants at cycle 5 with dose data | participants | NUMBER |
| PRIMARY | EP2006 Dose (Cycle 6) | Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician. | Number of participants at cycle 6 with dose data | participants | NUMBER |
| PRIMARY | EP2006 Dose by Patient Weight: Cycle Level | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | All cycles treated | cycles | NUMBER |
| PRIMARY | EP2006 Dose by Tumor Type: Cycle Level | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | cycles | NUMBER | |
| PRIMARY | Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor) | All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days | Evaluable sample by tumor type | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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