Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL) (NCT NCT00626795)
NCT ID: NCT00626795
Last Updated: 2025-03-12
Results Overview
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator. Investigator's assessment of severity of infections (SIRS). * Exudates/pus * Crusting * Erythema * Oedema * Tissue Warmth * Itching * Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: * 0 = absent * 2 = mild * 4 = moderate * 6 = severe The scores were summed up to a total SIRS score. Clinical cure was either of the following: * Total absence of signs and symptoms of impetigo/SITL OR * Improvement - total SIRS score reduced to \<8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4. Clinical failure was either of the following: * Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure * Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
773 participants
Primary outcome timeframe
At end of treatment (Day 8)
Results posted on
2025-03-12
Participant Flow
An open-label treatment consisting of one arm with 4 age groups of 16 participants treated with TD1414 cream three times daily was used in a stepwise inclusion, to detect major safety issues that could prevent the study from proceeding. The participants in the open-label phase were not included the efficacy analysis or in the randomized population
Participant milestones
| Measure |
TD1414 BID
TD1414 2% cream: two times daily (BID) 7 days
|
TD1414 TID
TD1414 2% cream: three times daily (TID) 7 days
|
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days
|
|---|---|---|---|
|
Open-label TD1414 Cream TID Treatment
STARTED
|
0
|
65
|
0
|
|
Open-label TD1414 Cream TID Treatment
COMPLETED
|
0
|
64
|
0
|
|
Open-label TD1414 Cream TID Treatment
NOT COMPLETED
|
0
|
1
|
0
|
|
Blinded Treatment
STARTED
|
204
|
205
|
205
|
|
Blinded Treatment
COMPLETED
|
194
|
200
|
196
|
|
Blinded Treatment
NOT COMPLETED
|
10
|
5
|
9
|
Reasons for withdrawal
| Measure |
TD1414 BID
TD1414 2% cream: two times daily (BID) 7 days
|
TD1414 TID
TD1414 2% cream: three times daily (TID) 7 days
|
Bactroban® TID
Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days
|
|---|---|---|---|
|
Open-label TD1414 Cream TID Treatment
Adverse Event
|
0
|
1
|
0
|
|
Blinded Treatment
Lack of Efficacy
|
2
|
0
|
0
|
|
Blinded Treatment
Unacceptable adverse event
|
0
|
0
|
1
|
|
Blinded Treatment
Protocol Violation
|
0
|
1
|
1
|
|
Blinded Treatment
Withdrawal by Subject
|
1
|
1
|
0
|
|
Blinded Treatment
Other reasons
|
2
|
0
|
2
|
|
Blinded Treatment
Missing reason for withdrawal
|
5
|
3
|
5
|
Baseline Characteristics
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
Baseline characteristics by cohort
| Measure |
TD1414 BID
n=204 Participants
TD1414 2% cream: two times daily (BID) 7 days
|
TD1414 TID
n=205 Participants
TD1414 2% cream: three times daily (TID) 7 days
|
Bactroban® TID
n=205 Participants
Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days
|
Total
n=614 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Participants assigned to open-label TD1414 TID
|
—
|
18.4 years
STANDARD_DEVIATION 20.0 • n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
—
|
18.4 years
STANDARD_DEVIATION 20.0 • n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Continuous
Participants randomized to blinded treatment
|
38.6 years
STANDARD_DEVIATION 14.8 • n=204 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
36.3 years
STANDARD_DEVIATION 14.3 • n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
38.3 years
STANDARD_DEVIATION 15.3 • n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
37.7 years
STANDARD_DEVIATION 14.8 • n=614 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Customized
Participants assigned to open-label TD1414 TID · ≥16 years old
|
0 Participants
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
17 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
17 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Customized
Participants assigned to open-label TD1414 TID · ≥12 to <16 years old
|
0 Participants
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
16 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
16 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Customized
Participants assigned to open-label TD1414 TID · ≥6 to <12 years old
|
0 Participants
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
16 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
16 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Customized
Participants assigned to open-label TD1414 TID · ≥2 to <6 years old
|
0 Participants
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
16 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
16 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Customized
Participants randomized to blinded treatment · ≥16 years old
|
193 Participants
n=204 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
194 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
195 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
582 Participants
n=614 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Customized
Participants randomized to blinded treatment · ≥12 to <16 years old
|
11 Participants
n=204 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
11 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
10 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
32 Participants
n=614 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Customized
Participants randomized to blinded treatment · ≥6 to <12 years old
|
0 Participants
n=204 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
n=614 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Age, Customized
Participants randomized to blinded treatment · ≥2 to <6 years old
|
0 Participants
n=204 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
0 Participants
n=614 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Sex: Female, Male
Participants assigned to open-label TD1414 TID · Female
|
—
|
35 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
—
|
35 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Sex: Female, Male
Participants assigned to open-label TD1414 TID · Male
|
—
|
30 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
—
|
30 Participants
n=65 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Sex: Female, Male
Participants randomized to blinded treatment · Female
|
97 Participants
n=204 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
93 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
110 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
300 Participants
n=614 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Sex: Female, Male
Participants randomized to blinded treatment · Male
|
107 Participants
n=204 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
112 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
95 Participants
n=205 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
314 Participants
n=614 Participants • 65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.
|
|
Region of Enrollment
United States
|
85 Participants
n=204 Participants
|
79 Participants
n=205 Participants
|
73 Participants
n=205 Participants
|
237 Participants
n=614 Participants
|
|
Region of Enrollment
South Africa
|
119 Participants
n=204 Participants
|
126 Participants
n=205 Participants
|
132 Participants
n=205 Participants
|
377 Participants
n=614 Participants
|
PRIMARY outcome
Timeframe: At end of treatment (Day 8)Population: All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator. Investigator's assessment of severity of infections (SIRS). * Exudates/pus * Crusting * Erythema * Oedema * Tissue Warmth * Itching * Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: * 0 = absent * 2 = mild * 4 = moderate * 6 = severe The scores were summed up to a total SIRS score. Clinical cure was either of the following: * Total absence of signs and symptoms of impetigo/SITL OR * Improvement - total SIRS score reduced to \<8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4. Clinical failure was either of the following: * Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure * Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
Outcome measures
| Measure |
TD1414 BID
n=203 Participants
TD1414 2% cream: two times daily (BID) for 7 days
|
TD1414 TID
n=205 Participants
TD1414 2% cream: three times daily (TID) for 7 days
|
Bactroban® TID
n=204 Participants
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
|
|---|---|---|---|
|
Participants With Clinical Cure According to Investigator's Assessment
Clinical cure
|
167 Participants
|
184 Participants
|
174 Participants
|
|
Participants With Clinical Cure According to Investigator's Assessment
Clinical failure
|
36 Participants
|
21 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: At follow up (Day 15)Population: All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.
At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
Outcome measures
| Measure |
TD1414 BID
n=203 Participants
TD1414 2% cream: two times daily (BID) for 7 days
|
TD1414 TID
n=205 Participants
TD1414 2% cream: three times daily (TID) for 7 days
|
Bactroban® TID
n=204 Participants
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
|
|---|---|---|---|
|
Participants With Clinical Cure According to Investigator's Assessment
Clinical cure
|
173 Participants
|
188 Participants
|
185 Participants
|
|
Participants With Clinical Cure According to Investigator's Assessment
Clinical failure
|
30 Participants
|
17 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (Day 8) and follow-up (Day 15)Population: All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.
At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.
Outcome measures
| Measure |
TD1414 BID
n=203 Participants
TD1414 2% cream: two times daily (BID) for 7 days
|
TD1414 TID
n=205 Participants
TD1414 2% cream: three times daily (TID) for 7 days
|
Bactroban® TID
n=204 Participants
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
|
|---|---|---|---|
|
Participants With Clinical Cure According to Investigator's Assessment.
Clinical cure
|
158 Participants
|
177 Participants
|
166 Participants
|
|
Participants With Clinical Cure According to Investigator's Assessment.
Clinical failure
|
45 Participants
|
28 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-upPopulation: Only the randomized participants that were infected with S. aureus or S. pyogenes at baseline were included in the analysis.
At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on. Bacteriological cure was either of the following: * Eradication of the baseline pathogen. * Presumed eradication of the baseline pathogen * Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic. Bacteriological failure was any of the following: * Documented lack of eradication of the baseline pathogen. * Documented relapse (re-infection) with the baseline pathogen * Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic * Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.
Outcome measures
| Measure |
TD1414 BID
n=110 Participants
TD1414 2% cream: two times daily (BID) for 7 days
|
TD1414 TID
n=121 Participants
TD1414 2% cream: three times daily (TID) for 7 days
|
Bactroban® TID
n=118 Participants
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
|
|---|---|---|---|
|
Participants With Bacteriological Cure According to Bacteriological Samples
End of treatment (Day 8) · Bacteriological cure
|
66 Participants
|
80 Participants
|
94 Participants
|
|
Participants With Bacteriological Cure According to Bacteriological Samples
Follow-up (Day 15) · Bacteriological cure
|
74 Participants
|
85 Participants
|
102 Participants
|
|
Participants With Bacteriological Cure According to Bacteriological Samples
Follow-up (Day 15) · Bacteriological failure
|
36 Participants
|
36 Participants
|
16 Participants
|
|
Participants With Bacteriological Cure According to Bacteriological Samples
End of Treatment and follow-up · Bacteriological cure
|
57 Participants
|
66 Participants
|
86 Participants
|
|
Participants With Bacteriological Cure According to Bacteriological Samples
End of Treatment and follow-up · Bacteriological failure
|
53 Participants
|
55 Participants
|
32 Participants
|
|
Participants With Bacteriological Cure According to Bacteriological Samples
End of treatment (Day 8) · Bacteriological failure
|
44 Participants
|
41 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-upPopulation: All participants randomized to blinded treatment who received at least one application of study medication and were infected with S. aureus or S. pyogenes at baseline were included in the analysis.
At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator. At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based.
Outcome measures
| Measure |
TD1414 BID
n=110 Participants
TD1414 2% cream: two times daily (BID) for 7 days
|
TD1414 TID
n=121 Participants
TD1414 2% cream: three times daily (TID) for 7 days
|
Bactroban® TID
n=118 Participants
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
|
|---|---|---|---|
|
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
End of treatment (Day 8) · Clinical or bacteriological failure
|
51 Participants
|
45 Participants
|
30 Participants
|
|
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
Follow-up (Day 15) · Clinical or bacteriological failure
|
40 Participants
|
42 Participants
|
19 Participants
|
|
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
End of Treatment and follow-up · Clinical or bacteriological failure
|
58 Participants
|
61 Participants
|
38 Participants
|
|
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
End of treatment (Day 8) · Clinical and bacteriological cure
|
59 Participants
|
76 Participants
|
88 Participants
|
|
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
Follow-up (Day 15) · Clinical and bacteriological cure
|
70 Participants
|
79 Participants
|
99 Participants
|
|
Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples
End of Treatment and follow-up · Clinical and bacteriological cure
|
52 Participants
|
60 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: At Day 4Population: All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.
At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.
Outcome measures
| Measure |
TD1414 BID
n=203 Participants
TD1414 2% cream: two times daily (BID) for 7 days
|
TD1414 TID
n=205 Participants
TD1414 2% cream: three times daily (TID) for 7 days
|
Bactroban® TID
n=204 Participants
Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
|
|---|---|---|---|
|
Participants With Clinical Cure According to Investigator's Assessment
Clinical cure
|
108 Participants
|
130 Participants
|
120 Participants
|
|
Participants With Clinical Cure According to Investigator's Assessment
Clinical failure
|
95 Participants
|
75 Participants
|
84 Participants
|
Adverse Events
TD1414 TID >=16 Years
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TD1414 TID >=12 to <16 Years
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TD1414 TID >=6 to <12 Years
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TD1414 TID >=2 to <6 Years
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TD1414 BID
Serious events: 2 serious events
Other events: 61 other events
Deaths: 0 deaths
TD1414 TID
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Bactroban® TID
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TD1414 TID >=16 Years
n=17 participants at risk
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
|
TD1414 TID >=12 to <16 Years
n=16 participants at risk
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
|
TD1414 TID >=6 to <12 Years
n=16 participants at risk
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
|
TD1414 TID >=2 to <6 Years
n=16 participants at risk
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
|
TD1414 BID
n=203 participants at risk
Blinded treatment TD1414 2% cream: two times daily (BID) for 7 days
|
TD1414 TID
n=205 participants at risk
Blinded treatment TD1414 2% cream: three times daily (TID) for 7 days
|
Bactroban® TID
n=204 participants at risk
Blinded treatment Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Hyperthermia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Penetrating abdominal trauma
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
Other adverse events
| Measure |
TD1414 TID >=16 Years
n=17 participants at risk
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
|
TD1414 TID >=12 to <16 Years
n=16 participants at risk
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
|
TD1414 TID >=6 to <12 Years
n=16 participants at risk
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
|
TD1414 TID >=2 to <6 Years
n=16 participants at risk
Open-label phase TD1414 2% cream: three times daily (TID) for 7 days
|
TD1414 BID
n=203 participants at risk
Blinded treatment TD1414 2% cream: two times daily (BID) for 7 days
|
TD1414 TID
n=205 participants at risk
Blinded treatment TD1414 2% cream: three times daily (TID) for 7 days
|
Bactroban® TID
n=204 participants at risk
Blinded treatment Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.98%
2/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Blood and lymphatic system disorders
Aneamia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Cardiac disorders
Long QT syndrome
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Application site irritation
|
5.9%
1/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
8.9%
18/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
7.8%
16/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
4.4%
9/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Application site pain
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
2.4%
5/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Application site pruritus
|
11.8%
2/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
2.0%
4/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
2.4%
5/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
2.5%
5/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Treatment failure
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Application site swelling
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Condition aggravated
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Local swelling
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
2.0%
4/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
1.5%
3/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.98%
2/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Impetigo
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
18.8%
3/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
3.0%
6/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
1.5%
3/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
1.5%
3/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.99%
2/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
1.5%
3/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Skin infection
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
1.5%
3/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.99%
2/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.99%
2/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
2.5%
5/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
3.4%
7/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
2.9%
6/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Blood pressure increased
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
1/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.99%
2/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Body temperature increased
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Transaminases increased
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
2.0%
4/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.98%
2/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
1.5%
3/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.98%
2/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Vascular disorders
Haematoma
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Vascular disorders
Hot flush
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.49%
1/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Streptococcal
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Infections and infestations
Wound infection
|
0.00%
0/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
6.2%
1/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
|
Investigations
Hepatic enzyme increased
|
5.9%
1/17 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/16 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/203 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/205 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
0.00%
0/204 • From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)
All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submit-ted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
- Publication restrictions are in place
Restriction type: OTHER