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Trial · NCT03428360

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE)Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study DrugAt least 1 TEAE84Participants
Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE)Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study DrugAt least 1 severe TEAE14Participants
Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE)Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study DrugAt least 1 study drug related TEAE10Participants
Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE)Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study DrugAt least 1 severe and related TEAE1Participants
Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE)Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study DrugAt least 1 serious TEAE18Participants
Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE)Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study DrugAt least 1 serious and related TEAE1Participants
Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI)Subjects With EpilepsyAny adverse event of special interest32participants
Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI)Subjects With EpilepsyAny oral irritation adverse event3participants
Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI)Subjects With EpilepsyAny oral safety adverse event8participants
Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI)Subjects With EpilepsyAny potential abuse related adverse event21participants
Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI)Subjects With EpilepsyAny abuse related adverse event1participants
Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI)Subjects With EpilepsyAny other adverse event of special interest8participants
Usability Assessment: Number of Use Occasions Where Difficulty in Opening the Outer Packaging Was Recorded.Total Use Occasions211total number of use occasions
Usability Assessment: Ability to Open Foil Pouch on Each Use OccasionStudy Drug Use OccasionsYes, I had difficulty opening the foil pouch391total number of use occasions
Usability Assessment: Ability to Open Foil Pouch on Each Use OccasionStudy Drug Use OccasionsNo, I did not have difficulty opening the foil pouch957total number of use occasions
Usability Assessment: Ability to Remove Study Drug From Foil Pouch on Each Use OccasionStudy Drug Use OccasionsYes, I had difficulty removing study drug from pouch on this occasion47total number of use occasions rpoeted
Usability Assessment: Ability to Remove Study Drug From Foil Pouch on Each Use OccasionStudy Drug Use OccasionsNo, I did not have difficulty removing study drug from the pouch on this occasion1301total number of use occasions rpoeted
Number of Occasions With Successful Insertion/Retention in CheekStudy Drug Use Occasions1330Number of events
Usability Assessment: Difficulty Inserting DBF Against the Buccal Mucosa (Number of Attempts to Insert Film for Each Use Occasion)Study Drug Use OccasionsNumber of occasions where it required 1 attempt to insert film1268Number of events
Usability Assessment: Difficulty Inserting DBF Against the Buccal Mucosa (Number of Attempts to Insert Film for Each Use Occasion)Study Drug Use OccasionsNumber of occasions that required 2 attempts to insert film38Number of events

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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