Trial · NCT02426086
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Spleen Response | Week 24 | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Symptom Response | Week 24 | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Response as Per Modified 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Improvement (CI) Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response Per Modified 2013 IWG-MRT | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Spleen Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. All treated participants were evaluated for each response. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Symptoms Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. All treated participants were evaluated for each response. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Anemia Response Per Modified 2013 IWG-MRT Criteria | Every 12 weeks up to Week 48 then every 24 weeks (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. All treated participants were evaluated for each response. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (PR/CI/RWCI) as Per IWG-MRT Criteria | From date of initial documentation of a response to the date of first documented evidence of PD or death, whichever occurs first (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were responders (PR/CI/RWCI) at any time. | weeks | MEDIAN |
| SECONDARY | Overall Survival | Day 1 of Cycle 1 (each cycle was of 21 days), up to the date of the participant's death (approximately up to 4.1 years) | Treated analysis set included all participants who received at least 1 dose of study drug. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Clinically Meaningful Improvement in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-C30): Global Health Status | Up to end of the treatment (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. Here, overall number of participants analyzed signifies the number of participants who had data at both baseline and end of treatment. | percentage of participants | NUMBER |
| SECONDARY | EuroQol 5 Dimension 5 Level (EQ-5D-5L): Utility Score and Visual Analog Scale (VAS) | At the end of treatment, up to approximately 2.3 years | Treated analysis set included all participants who received at least 1 dose of study drug. Here N= participants who had data at both baseline and end of treatment. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With Clinically Meaningful Improvement in Brief Pain Inventory (BPI) | Up to end of treatment (approximately up to 2.3 years) | Treated analysis set included all participants who received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who had data at both baseline and end of treatment and Number analyzed signifies the number of participants with data available for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Patient's Global Impression of Change (PGIC) | At the end of treatment, up to approximately 2.3 years | Treated analysis set included all participants who received at least 1 dose of study drug. Here, overall number of participants analyzed signifies number of subjects who had data at both baseline and end of treatment. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to end of extension phase (approximately up to 4.2 years) | Safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Imetelstat | 0 (before start of infusion), 1, 2, 3-5, 6-10, 12-16 and 18-24 hours post dose on Day 1 of Cycle 1 (each cycle was of 21 days) | Pharmacokinetic (PK) subset included all participants who had serial PK sampling during cycle 1 treatment to determine the maximum plasma concentration of Imetelstat by noncompartmental PK analysis. | μg/mL | MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Imetelstat | 0 (before start of infusion), 1, 2, 3-5, 6-10, 12-16 and 18-24 hours post dose on Day 1 of Cycle 1 (each cycle was of 21 days) | PK subset included all participants who had serial PK sampling during cycle 1 treatment to determine the time to reach maximum plasma concentration of imetelstat by noncompartmental PK analysis. | hr | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC 0-24) of Imetelstat | 0 (before start of infusion), 1, 2, 3-5, 6-10, 12-16 and 18-24 hours post dose on Day 1 of Cycle 1 (each cycle was of 21 days) | PK subset included all participants who had serial PK sampling during cycle 1 treatment to determine the AUC 0-24 of Imetelstat by noncompartmental PK analysis. | μg*hr/mL | MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUC0-inf) of Imetelstat | 0 (before start of infusion), 1, 2, 3-5, 6-10, 12-16 and 18-24 hours post dose on Day 1 of Cycle 1 (each cycle was of 21 days) | PK subset included all participants who had serial PK sampling during cycle 1 treatment to determine AUC 0-inf of Imetelstat by noncompartmental PK analysis. | μg*h/mL | MEAN |
| SECONDARY | Elimination Half-Life (t1/2) of Imetelstat | 0 (before start of infusion), 1, 2, 3-5, 6-10, 12-16 and 18-24 hours post dose on Day 1 of Cycle 1 (each cycle was of 21 days) | PK subset included all participants who had serial PK sampling during cycle 1 treatment to determine the t1/2 of Imetelstat by noncompartmental PK analysis. | hr | MEAN |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02426086/outcomes