Trial Outcomes & Findings for A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome (NCT NCT03992196)
NCT ID: NCT03992196
Last Updated: 2023-10-30
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (ie, on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
From Baseline until the Safety Follow-Up Visit (up to 14 Months)
Results posted on
2023-10-30
Participant Flow
The study started to enroll participants in December 2019 and concluded prematurely in September 2022. Study participants entered this study from the parent rotigotine study in adolescents (SP1006) (NCT03728933).
10 participants were screened and considered enrolled, but only 9 participants were treated. The 10th participant was lost to follow-up prior dosing and no Adverse events were reported for this participant. Participant Flow refers to the Enrolled Set.
Participant milestones
| Measure |
No Treatment
Participant signed the informed consent form but never received any study medication during the study.
|
Rotigotine Final Dose 2 mg/24 h
Participants in this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
|---|---|---|---|
|
Enrollment
STARTED
|
1
|
2
|
7
|
|
Enrollment
COMPLETED
|
0
|
2
|
7
|
|
Enrollment
NOT COMPLETED
|
1
|
0
|
0
|
|
Treatment
STARTED
|
0
|
2
|
7
|
|
Treatment
COMPLETED
|
0
|
2
|
1
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
No Treatment
Participant signed the informed consent form but never received any study medication during the study.
|
Rotigotine Final Dose 2 mg/24 h
Participants in this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
|---|---|---|---|
|
Enrollment
lost to follow-up prior dosing
|
1
|
0
|
0
|
|
Treatment
Protocol Violation
|
0
|
0
|
1
|
|
Treatment
Poor drug compliance withdrawn by team and sponsor
|
0
|
0
|
1
|
|
Treatment
Withdrawal due to non-compliance
|
0
|
0
|
1
|
|
Treatment
PI's decision due to investigational medicinal product non-compliance
|
0
|
0
|
1
|
|
Treatment
Withdrawal by parent/guardian
|
0
|
0
|
2
|
Baseline Characteristics
A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
Baseline characteristics by cohort
| Measure |
Rotigotine Final Dose 2 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
n=7 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Adolescents (12-17 years)
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline until the Safety Follow-Up Visit (up to 14 Months)Population: The Safety Set consisted of all participants who had at least one patch (rotigotine) applied.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (ie, on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame.
Outcome measures
| Measure |
Rotigotine Final Dose 2 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
n=7 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
85.7 percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline until the Safety Follow-Up Visit (up to 14 Months)Population: The Safety Set consisted of all participants who had at least one patch (rotigotine) applied.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (ie, on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame.
Outcome measures
| Measure |
Rotigotine Final Dose 2 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
n=7 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Study Medication
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Visit 9 (Month 12), compared to Baseline (in SP1006)Population: The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.
The IRLS consisted of 10 questions, each scored using a 5-point scale ranging from 0=not present to 4=very severe. The IRLS sum score was calculated by summing up the single scores of all applicable questions, i.e., the total sum score ranged from 0 (no RLS symptoms present) to 40 (maximum severity in all symptoms). A score between 31 and 40, indicates very severe RLS. A score between 21 and 30 indicates severe RLS. A score between 11 and 20 indicates moderate RLS. A score between 1 and 10 indicates mild RLS and a score of 0 means no RLS. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Rotigotine Final Dose 2 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
|---|---|---|
|
Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
SECONDARY outcome
Timeframe: Visit 9 (Month 12), compared to Baseline (in SP1006)Population: The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.
The Clinical Global Impressions Item 1 (Severity of Illness) score ranges from 0 to 7 as follows: 0=not assessed, 1=normal, not ill at all, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill. The CGI Item 1 was completed during an interview between the participant and the investigator or designee. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Rotigotine Final Dose 2 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
|---|---|---|
|
Changes From Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
SECONDARY outcome
Timeframe: Visit 9 (Month 12), compared to Baseline (in SP1006)Population: The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.
The RLS-6 Rating Scales was designed to assess the severity of RLS and consisted of 6 subscales. The subscales assessed severity of symptoms at the following times of the day/evening: falling asleep, during the night, during the day at rest, and during the day when engaged in daytime activities (not at rest). In addition, the subscales assessed satisfaction with sleep and severity of daytime tiredness/sleepiness. Scores for each of the 6 subscales ranged from 0 (completely satisfied) to 10 (completely dissatisfied). The change from baseline was derived for each of the subscales and reported in this outcome measure. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Rotigotine Final Dose 2 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
n=2 Participants
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
|---|---|---|
|
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
Satisfaction with sleep
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
|
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
Severity: RLS symptoms at falling asleep
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
|
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
Severity: RLS symptoms during the night
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
|
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
Severity: RLS symptoms during the day - at rest
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
|
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
Severity: RLS symptoms during the day-not at rest
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
|
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
How tired or sleepy during the day
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
NA score on a scale
Standard Deviation NA
Summary statistics are not reported for N\<3 due to small sample size and participant identification issues.
|
Adverse Events
Rotigotine Final Dose 2 mg/24 h
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Rotigotine Final Dose 3 mg/24 h
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rotigotine Final Dose 2 mg/24 h
n=2 participants at risk
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
Rotigotine Final Dose 3 mg/24 h
n=7 participants at risk
Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
42.9%
3/7 • Number of events 5 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
General disorders
Application site erythema
|
100.0%
2/2 • Number of events 2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
28.6%
2/7 • Number of events 2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
General disorders
Application site rash
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
1/2 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Infections and infestations
Ear infection
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Infections and infestations
Suspected COVID-19
|
50.0%
1/2 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
0.00%
0/7 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
50.0%
1/2 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
0.00%
0/7 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
50.0%
1/2 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
0.00%
0/7 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/2 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
14.3%
1/7 • Number of events 1 • From Baseline until the Safety Follow-Up Visit (up to 14 Months)
TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60