Trial · NCT04485104
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks | Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set. | participants | NUMBER |
| PRIMARY | Mean Change From Baseline in Blood Pressure | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Blood pressure was assessed in the Safety Analysis Set. | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline in Pulse Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Pulse rate was assessed in the Safety Analysis Set. | beats per minute | MEAN |
| PRIMARY | Mean Change From Baseline in Respiratory Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Respiratory rate was assessed in the Safety Analysis Set. | breaths/minute | MEAN |
| PRIMARY | Mean Change From Baseline in Body Temperature | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Body temperature was assessed in the Safety Analysis Set. | degrees Celsius | MEAN |
| PRIMARY | Mean Change From Baseline in Height | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Height was assessed in the Safety Analysis Set. | centimeters | MEAN |
| PRIMARY | Mean Change From Baseline in Body Weight | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Body weight was assessed in the Safety Analysis Set. | kilogram | MEAN |
| PRIMARY | Mean Change From Baseline in Heart Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Heart rate was assessed in participants with available data in the Safety Analysis Set. | beats/minute | MEAN |
| PRIMARY | Mean Change From Baseline in RR Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | RR interval was assessed in participants with available data in the Safety Analysis Set. | millisecond | MEAN |
| PRIMARY | Mean Change From Baseline in PR Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | PR interval was assessed in the Safety Analysis Set. | millisecond | MEAN |
| PRIMARY | Mean Change From Baseline in QRS Duration | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | QRS duration was assessed in the Safety Analysis Set. | millisecond | MEAN |
| PRIMARY | Mean Change From Baseline in QT Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | QT interval was assessed in the Safety Analysis Set. | millisecond | MEAN |
| PRIMARY | Mean Change From Baseline in QTcB and QTcF | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | QTcB and QTcF were assessed in participants with available data in the Safety Analysis Set. | millisecond | MEAN |
| PRIMARY | Number of Participants With a Clinically Significant Change in Laboratory Parameters | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | Clinically significant change in laboratory parameters were assessed in participants with available data in the Safety Analysis Set. | participants | NUMBER |
| PRIMARY | Number of Participants With Emergence of New Types of Seizures | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | New types of seizures were assessed in the Safety Analysis Set. | participants | NUMBER |
| PRIMARY | Plasma Concentrations of GWP42003-P and Its Major Metabolites | Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52) | Pharmacokinetics were assessed and reported for participants when samples were collected. For both participants with Tuberous Sclerosis Complex, it was not possible to collect PK samples at 6hr post dose. | ng/mL | MEAN |
| PRIMARY | Number of Participants Based on Percentage Change From Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers | Day 1 up to Taper Period, up to Week 52 | Indication-specific total countable seizures where assessed in the Safety Analysis Set. | participants | NUMBER |
| PRIMARY | Clinician Global Impression of Severity (CGI/S) Score | At Day 365 (EOT) | CGI-S was assessed and reported for the participant with Dravet Syndrome. As both participants with Tuberous Sclerosis Complex consented under a previous protocol version that did not include CGI S, this assessment was not collected for these participants. | score on a scale | MEAN |
| PRIMARY | Clinician Global Impression of Change (CGI/C) Score | At Day 365 (EOT) | CGI-C was assessed and reported for the participant with Dravet Syndrome. As both participants with Tuberous Sclerosis Complex consented under a previous protocol version that did not include CGI-C, this assessment was not collected for these participants. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) Score | At Day 365 (EOT) | ITQOL-47 score was assessed in participants with available data in the Safety Analysis Set. | score on a scale | 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/NCT04485104/outcomes