Trial Outcomes & Findings for Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa (NCT NCT02090283)
NCT ID: NCT02090283
Last Updated: 2019-11-04
Results Overview
Treatment-emergent adverse events were defined as adverse events that started or worsened on or after baseline visit, which occurred at the final visit date for the SD-003 study. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
From baseline to 30 days after last application of study drug (up to a maximum of 54 months)
Results posted on
2019-11-04
Participant Flow
42 participants with epidermolysis bullosa (EB) were enrolled in this open-label, multi-center extension study. All enrolled participants had previously completed Study SD-003 (NCT02014376).
Analysis groups were defined based on prior treatment in Study SD-003: those who received placebo were allocated to the 'Placebo to SD-101-6.0' group, those who received SD-101-3.0 were allocated to the 'SD-101-3.0 to SD-101-6.0' group, and those who received SD-101-6.0 were allocated to the 'SD-101-6.0 to SD-101-6.0' group.
Participant milestones
| Measure |
Placebo to SD-101-6.0
Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-3.0 to SD-101-6.0
Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-6.0 to SD-101-6.0
Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
10
|
|
Overall Study
Received At Least 1 Dose Of Study Drug
|
17
|
15
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
10
|
Reasons for withdrawal
| Measure |
Placebo to SD-101-6.0
Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-3.0 to SD-101-6.0
Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-6.0 to SD-101-6.0
Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
6
|
|
Overall Study
Sponsor Terminated Study
|
6
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
3
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
Baseline Characteristics
Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
Baseline characteristics by cohort
| Measure |
Placebo to SD-101-6.0
n=17 Participants
Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-3.0 to SD-101-6.0
n=15 Participants
Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-6.0 to SD-101-6.0
n=10 Participants
Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.29 years
STANDARD_DEVIATION 10.385 • n=5 Participants
|
15.70 years
STANDARD_DEVIATION 15.928 • n=7 Participants
|
8.10 years
STANDARD_DEVIATION 4.795 • n=5 Participants
|
12.11 years
STANDARD_DEVIATION 11.945 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African-American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
EB Subtype
Simplex
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
EB Subtype
Recessive Dystrophic
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
EB Subtype
Junctional non-Herlitz
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to 30 days after last application of study drug (up to a maximum of 54 months)Population: Safety: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug.
Treatment-emergent adverse events were defined as adverse events that started or worsened on or after baseline visit, which occurred at the final visit date for the SD-003 study. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo to SD-101-6.0
n=17 Participants
Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-3.0 to SD-101-6.0
n=15 Participants
Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-6.0 to SD-101-6.0
n=10 Participants
Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
|---|---|---|---|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
13 Participants
|
14 Participants
|
5 Participants
|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE Related to Study Drug
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any Fatal TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAE
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE Leading to Discontinuation
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Intent to Treat: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug.
Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. The percentage, ranging from 0% to 100%, of affected body surface area (BSA) was recorded for each defined body region (that is, head/neck, upper limbs, trunk \[includes groin\], and lower limbs), multiplied by the weighting factor, and then summed for all body regions to calculate the BSAI. The BSA for lesional skin was to be assessed by the same study physician on each visit for a particular participant. The mean change from baseline (final visit from the SD-003 study) in BSAI was assessed every 3 months. Only participants with data available for analysis at the specified time point are presented.
Outcome measures
| Measure |
Placebo to SD-101-6.0
n=9 Participants
Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-3.0 to SD-101-6.0
n=9 Participants
Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-6.0 to SD-101-6.0
n=3 Participants
Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
|---|---|---|---|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 24
|
1.99 percentage of BSAI
Standard Deviation 6.728
|
-3.73 percentage of BSAI
Standard Deviation 6.152
|
-9.50 percentage of BSAI
Standard Deviation 21.248
|
Adverse Events
Placebo to SD-101-6.0
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
SD-101-3.0 to SD-101-6.0
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
SD-101-6.0 to SD-101-6.0
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo to SD-101-6.0
n=17 participants at risk
Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-3.0 to SD-101-6.0
n=15 participants at risk
Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-6.0 to SD-101-6.0
n=10 participants at risk
Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
|---|---|---|---|
|
Infections and infestations
Rhinovirus infection
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Cardiac disorders
Bradycardia
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Cardiac disorders
Cyanosis
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
General disorders
Pain
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
General disorders
Pyrexia
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Gastroenteritis viral
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Staphylococcal infection
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Tracheitis
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Psychiatric disorders
Major depression
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
Other adverse events
| Measure |
Placebo to SD-101-6.0
n=17 participants at risk
Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-3.0 to SD-101-6.0
n=15 participants at risk
Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
SD-101-6.0 to SD-101-6.0
n=10 participants at risk
Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.6%
3/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Eye disorders
Chalazion
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Eye disorders
Dry eye
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Eye disorders
Myopia
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Oesophageal perforation
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
General disorders
Pyrexia
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
26.7%
4/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
General disorders
Pain
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
General disorders
Application site pain
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
General disorders
Developmental delay
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
General disorders
Fatigue
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
General disorders
Peripheral swelling
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Skin infection
|
23.5%
4/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Ear infection
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Wound infection
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Clostridium difficile infection
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Conjunctivitis
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Corona virus infection
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Device related infection
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Localised infection
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Mastitis
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Pseudomonas infection
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Stoma site cellulitis
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Investigations
Blood urine present
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Investigations
Haemoglobin decreased
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Investigations
Pancreatic enzymes decreased
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Investigations
Serum ferritin decreased
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Musculoskeletal and connective tissue disorders
Pseudosyndactyly
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Psychiatric disorders
Affective disorder
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Psychiatric disorders
Borderline personality disorder
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
20.0%
3/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
10.0%
1/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
|
Surgical and medical procedures
Cyst removal
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
0.00%
0/10 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60