Trial · NCT02408549
Outcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants Withdrawn Due to TEAEs | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With an Increase of up to 25% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982) | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With an Increase of Greater Than (>)25% to 50% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982) | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With an Increase of >50% to 75% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982) | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With an Increase of >75% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982) | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With an Increase of up to 25% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982) | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With an Increase of >25% to 50% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982) | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With an Increase of >50% to 75% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982) | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With an Increase of >75% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982) | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Study Participants With at Least 50% Worsening in Days With Absence Seizures | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (absence seizures). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Study Participants With at Least 50% Worsening in Days With Myoclonic Seizures | From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Here, Number of participants analyzed included those participants who were evaluable for the assessment (myoclonic seizures). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin) | During the study (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Hematology parameter (Hemoglobin) observed during the study were reported in this assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit) | During the study (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Hematology parameter (Hematocrit) observed during the study were reported in this assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Platelets) | During the study (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. No participant had TEMA value (platelets) with markedly abnormal criteria specified at any visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Erythrocytes) | During the study (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Data for visit (Early TV) wherein at least 1 TEMA value of Hematology parameter (Erythrocytes) observed during the study was reported in this assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Leukocytes) | During the study (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Data for visit (Week 62-Low) wherein at least 1 TEMA value of Hematology parameter (Leukocytes) observed during the study was reported in this assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Basophils Absolute) | During the study (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Data for visit (Week 2) wherein at least 1 TEMA value of Hematology parameter (Basophils Absolute) observed during the study was reported in this assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Eosinophils Absolute) | During the study (up to approximately 5 years) | The Safety Set included all study participants who received at least 1 dose of IMP during this study. Number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed signifies participants who were evaluable at specified time points. Data for visits wherein at least 1 TEMA value of Hematology parameter (Eosinophils Absolute) observed during the study were reported in this assessment. | percentage of 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02408549/outcomes