Trial Outcomes & Findings for Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (NCT NCT03068780)
NCT ID: NCT03068780
Last Updated: 2023-07-20
Results Overview
Proportion of subjects with first complete closure of the EB target wound (defined as EB partial-thickness wound of 10 cm2 to 50 cm2 in size and ≥21 days to \<9 months in age) in subjects with inherited EB (subtypes DEB, JEB, or Kindler EB) within 45 days of treatment with Oleogel-S10 compared to control gel based on clinical assessment by the investigator (the wound was rated as "closed" at first appearance of complete re-epithelialization without drainage).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
223 participants
Primary outcome timeframe
45±7 days
Results posted on
2023-07-20
Participant Flow
All subjects satisfied the inclusion / exclusion criteria based on investigator assessment prior to entry into the study. 29 out of a total of 252 screened patients were reported as screen failures.
Participant milestones
| Measure |
Oleogel-S10
Oleogel-S10 (DBP \& OLP): 10% birch bark extract in 90% sunflower oil
|
Control Gel
Control gel (DBP): Vehicle gel; Oleogel-S10 (OLP): 10% birch bark extract in 90% sunflower oil
|
|---|---|---|
|
Double-Blind Phase (DBP)
STARTED
|
109
|
114
|
|
Double-Blind Phase (DBP)
COMPLETED
|
100
|
99
|
|
Double-Blind Phase (DBP)
NOT COMPLETED
|
9
|
15
|
|
Open-Label Phase (OLP)
STARTED
|
100
|
105
|
|
Open-Label Phase (OLP)
COMPLETED
|
66
|
75
|
|
Open-Label Phase (OLP)
NOT COMPLETED
|
34
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa
Baseline characteristics by cohort
| Measure |
Oleogel-S10
n=109 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=114 Participants
Control gel: Vehicle gel (all subjects switched to Oleogel-S10 in the OLP)
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 4 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
4 to <12 years
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Age, Customized
12 to <18 years
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Customized
18 years and older
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
95 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not applicable (applies in countries where the collection of race was prohibited)
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (applies if none of the races listed were appropriate or if the subject was of mixed race)
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
48 participants
n=5 Participants
|
55 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Region of Enrollment
South America
|
33 participants
n=5 Participants
|
35 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Epidermolysis Bullosa Subtype
RDEB (recessive dystrophic epidermolysis bullosa)
|
91 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Epidermolysis Bullosa Subtype
DDEB (dominant dystrophic epidermolysis bullosa)
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Epidermolysis Bullosa Subtype
JEB (junctional epidermolysis bullosa)
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Epidermolysis Bullosa Subtype
EBS (epidermolysis bullosa simplex)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Epidermolysis Bullosa Subtype
Kindler EB
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
16.05 kg/m²
STANDARD_DEVIATION 4.979 • n=5 Participants
|
16.31 kg/m²
STANDARD_DEVIATION 5.037 • n=7 Participants
|
16.18 kg/m²
STANDARD_DEVIATION 4.999 • n=5 Participants
|
PRIMARY outcome
Timeframe: 45±7 daysPopulation: Full Analysis Set (FAS)
Proportion of subjects with first complete closure of the EB target wound (defined as EB partial-thickness wound of 10 cm2 to 50 cm2 in size and ≥21 days to \<9 months in age) in subjects with inherited EB (subtypes DEB, JEB, or Kindler EB) within 45 days of treatment with Oleogel-S10 compared to control gel based on clinical assessment by the investigator (the wound was rated as "closed" at first appearance of complete re-epithelialization without drainage).
Outcome measures
| Measure |
Oleogel-S10
n=109 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=114 Participants
Control gel: Vehicle gel
|
|---|---|---|
|
Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment
|
45 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 90±7 daysPopulation: Full Analysis Set (FAS)
The first key secondary endpoint was time to first complete closure of the EB target wound as evidenced by clinical assessment within 90 days or by EDBP, using a nonstratified log-rank test. If the primary analysis of the primary efficacy endpoint showed superiority at the 5% significance level, hierarchical confirmatory testing of the 6 key secondary endpoints was to be performed.
Outcome measures
| Measure |
Oleogel-S10
n=109 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=114 Participants
Control gel: Vehicle gel
|
|---|---|---|
|
Time to First Complete Closure of the EB Target Wound as Evidenced by Clinical Assessment Until Day 90 (D90) or End of Double-blind Phase (EDBP)
|
92.0 days
Interval 50.0 to
Confidence interval for the median time to first complete closure was not estimable since the survivor function of the upper confidence limit did not reach 0.5 (upper limit not estimable)
|
94.0 days
Interval 89.0 to
Confidence interval for the median time to first complete closure was not estimable since the survivor function of the upper confidence limit did not reach 0.5 (upper limit not estimable)
|
SECONDARY outcome
Timeframe: 90±7 daysPopulation: Full Analysis Set (FAS)
The second key secondary endpoint was the proportion of subjects with first complete closure of the EB target wound within 90 days of treatment or by EDBP based on clinical assessment by the investigator.
Outcome measures
| Measure |
Oleogel-S10
n=109 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=114 Participants
Control gel: Vehicle gel
|
|---|---|---|
|
Proportion of Patients With First Complete Closure of the EB Target Wound at D90 or EDBP Based on Clinical Assessment by the Investigator Until D90 or EDBP
|
55 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 90±7 daysPopulation: Full Analysis Set (FAS)
The incidence of EB target wound infections between Baseline (DBP D0) and D90 or EDBP was assessed based on the total number of patients with an EB target wound infection, as evidenced by AEs and/or the use of topical and/or systemic antibiotics, and the total number of patients
Outcome measures
| Measure |
Oleogel-S10
n=109 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=114 Participants
Control gel: Vehicle gel
|
|---|---|---|
|
The Incidence of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by Adverse Events (AEs) and/or Use of Topical and/or Systemic Antibiotics (Related to Wound Infection)
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 90±7 daysPopulation: Full Analysis Set (FAS)
Target wound infections between baseline (DBP D0) and D90 or EDBP were assessed for maximum severity (maximum severity was evaluated if a subject had a wound infection event evidenced by AEs). \[Note: Here, 1 event less is recorded in the control gel group as for the previous secondary outcome measure, because only wound infections that were reported as AEs could be assessed for severity and were included in this analysis.\]
Outcome measures
| Measure |
Oleogel-S10
n=109 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=114 Participants
Control gel: Vehicle gel
|
|---|---|---|
|
The Maximum Severity of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by AEs
Maximum severity of wound infection: Mild
|
1 Participants
|
0 Participants
|
|
The Maximum Severity of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by AEs
No wound infection
|
108 Participants
|
110 Participants
|
|
The Maximum Severity of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by AEs
Maximum severity of wound infection: Moderate
|
0 Participants
|
3 Participants
|
|
The Maximum Severity of EB Target Wound Infection Between Baseline (DBP D0) and D90 or EDBP as Evidenced by AEs
Maximum severity of wound infection: Severe
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90±7 daysPopulation: Patients with EBDASI skin activity score
The evaluation of total body wound burden (TBWB) was based on clinical assessment using Section I (Skin) of the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). The EBDASI skin activity (blistering/erosions/crusting) was scored from 0 to 10 for each of 10 anatomical locations (excluding the anogenital and buttocks regions). Therefore, the total skin activity score (i.e., TBWB) could range from 0 to 100, with lower scores indicative of less wound burden. The change in TBWB was assessed from baseline (DBP D0) to D90 or EDBP.
Outcome measures
| Measure |
Oleogel-S10
n=84 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=85 Participants
Control gel: Vehicle gel
|
|---|---|---|
|
Change From Baseline (DBP D0) in Total Body Wound Burden as Evidenced by Clinical Assessment Using Section I (Assessment of the Skin Except for the Anogenital Region) of the 'EB Disease Activity and Scarring Index' (EBDASI), at D90 or EDBP
|
-0.44 score on a scale
Standard Error 0.90
|
-0.56 score on a scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: 90±7 daysPopulation: Patients with Itch Man Score
Change from Baseline at D90 or EDBP on the Itch Man Scale in patients 4-13 years of age. The scale runs from 0 (comfortable, no itch) to 4 (itches most terribly, impossible to sit still, concentrate).
Outcome measures
| Measure |
Oleogel-S10
n=39 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=43 Participants
Control gel: Vehicle gel
|
|---|---|---|
|
Change From Baseline (DBP D0) in Itching Using the 'Itch Man Scale' in Patients ≥ 4 Years and up to 13 Years of Age Before Wound Dressing Changes at D90 or EDBP
|
-0.44 score on a scale
Standard Deviation 1.31
|
-1.00 score on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 90±7 daysPopulation: Patients with Leuven Itch Score
Change in Leuven Itch Scale (patients ≥ 14 years of age) scores taken from two time points, Baseline and Day 90±7 \[End of Double Blind Phase (EDBP)\]. The Leuven Itch Scale measures six dimensions of the itch experience: Frequency Subscore (0 = Never to 100 = Always); Duration Subscore (0 = Between 0 and 30 minutes to 100 = More than 2 hours); Severity Subscore (0 = No itch to 100 = Worst possible itch); Consequences Subscore \[0 = Never to 100 = Always (lower score indicates less negative consequences from the itch)\]; Distress Subscore (0 = Not distressing at all to 100 = Very distressing); Surface Area Subscore (0-100, high values indicate more parts of the body are itching)
Outcome measures
| Measure |
Oleogel-S10
n=52 Participants
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel
n=48 Participants
Control gel: Vehicle gel
|
|---|---|---|
|
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Frequency subscore (change from baseline)
|
-8.13 score on a scale
Standard Deviation 26.18
|
-10.14 score on a scale
Standard Deviation 27.3
|
|
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Duration subscore (change from baseline)
|
-0.93 score on a scale
Standard Deviation 35.174
|
0.98 score on a scale
Standard Deviation 39.768
|
|
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Severity subscore (change from baseline)
|
-4.95 score on a scale
Standard Deviation 19.33
|
-10.76 score on a scale
Standard Deviation 32.68
|
|
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Consequences subscore (change from baseline)
|
-4.39 score on a scale
Standard Deviation 14.073
|
-3.54 score on a scale
Standard Deviation 19.402
|
|
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Distress subscore (change from baseline)
|
-0.44 score on a scale
Standard Deviation 22.87
|
-0.26 score on a scale
Standard Deviation 34.87
|
|
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Surface area subscore (change from baseline)
|
-1.54 score on a scale
Standard Deviation 12.347
|
0.68 score on a scale
Standard Deviation 17.082
|
Adverse Events
Oleogel-S10 (DBP)
Serious events: 7 serious events
Other events: 89 other events
Deaths: 0 deaths
Control Gel (DBP)
Serious events: 6 serious events
Other events: 92 other events
Deaths: 0 deaths
Former Oleogel-S10 (OLP)
Serious events: 26 serious events
Other events: 77 other events
Deaths: 7 deaths
Former Control Gel (OLP)
Serious events: 24 serious events
Other events: 81 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Oleogel-S10 (DBP)
n=109 participants at risk
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel (DBP)
n=114 participants at risk
Control gel: Vehicle Gel
|
Former Oleogel-S10 (OLP)
n=100 participants at risk
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Former Control Gel (OLP)
n=105 participants at risk
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
|---|---|---|---|---|
|
Infections and infestations
septic shock
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
2.0%
2/100 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Wound infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.88%
1/114 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.9%
2/105 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
2.0%
2/100 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
COVID-19
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
2.0%
2/100 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Pneumonia
|
0.92%
1/109 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
4.0%
4/100 • Number of events 9 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
5.7%
6/105 • Number of events 6 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.9%
2/105 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
3/109 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
4.0%
4/100 • Number of events 7 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
5.7%
6/105 • Number of events 8 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.9%
2/105 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma skin
|
0.92%
1/109 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
3.0%
3/100 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Musculoskeletal and connective tissue disorders
Pseudosyndactyly
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
2.0%
2/100 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia/
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.88%
1/114 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Device related infection
|
0.92%
1/109 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Erysipelas
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.88%
1/114 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Sepsis
|
0.92%
1/109 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.8%
2/114 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.88%
1/114 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Wound infection bacterial
|
0.92%
1/109 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.88%
1/114 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.88%
1/114 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.92%
1/109 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Renal and urinary disorders
Haematuria
|
0.92%
1/109 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Congenital, familial and genetic disorders
Syndactyly
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Anal stenosis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Fecaloma
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Gastrointestinal haemmorrhage
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Intestinal Ischemia
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Oesophageal mucosal blister
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
General disorders
Asthenia
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
General disorders
Disease progression
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Blister infected
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Immune system disorders
Klebsiella infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Otitis externa
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Skin infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Injury, poisoning and procedural complications
Laryngeal injury
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/105 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Reproductive system and breast disorders
Pelvic congestion
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
Other adverse events
| Measure |
Oleogel-S10 (DBP)
n=109 participants at risk
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Control Gel (DBP)
n=114 participants at risk
Control gel: Vehicle Gel
|
Former Oleogel-S10 (OLP)
n=100 participants at risk
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
Former Control Gel (OLP)
n=105 participants at risk
Oleogel-S10: 10% birch bark extract in 90% sunflower oil
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Wound complication
|
61.5%
67/109 • Number of events 100 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
53.5%
61/114 • Number of events 88 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
38.0%
38/100 • Number of events 43 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
43.8%
46/105 • Number of events 64 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Wound infection
|
7.3%
8/109 • Number of events 9 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
8.8%
10/114 • Number of events 12 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
6.0%
6/100 • Number of events 12 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
14.3%
15/105 • Number of events 26 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Wound infection staphylococcal
|
3.7%
4/109 • Number of events 4 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
2.6%
3/114 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
9.0%
9/100 • Number of events 14 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
11.4%
12/105 • Number of events 15 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Wound infection bacterial
|
2.8%
3/109 • Number of events 4 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
4.4%
5/114 • Number of events 6 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
7.0%
7/100 • Number of events 10 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
8.6%
9/105 • Number of events 14 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.88%
1/114 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
8.0%
8/100 • Number of events 16 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
10.5%
11/105 • Number of events 14 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
2/109 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.88%
1/114 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
6.0%
6/100 • Number of events 8 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
6.7%
7/105 • Number of events 9 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
8/109 • Number of events 10 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
3.5%
4/114 • Number of events 4 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
16.0%
16/100 • Number of events 24 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
20.0%
21/105 • Number of events 30 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
General disorders
Pyrexia
|
8.3%
9/109 • Number of events 11 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
13.2%
15/114 • Number of events 18 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
10.0%
10/100 • Number of events 13 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
9.5%
10/105 • Number of events 15 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
8/109 • Number of events 8 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
5.3%
6/114 • Number of events 7 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
5.0%
5/100 • Number of events 5 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
8.6%
9/105 • Number of events 13 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
3/109 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
7.0%
8/114 • Number of events 9 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
2.0%
2/100 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 1 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/109 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.8%
2/114 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
3.0%
3/100 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
5.7%
6/105 • Number of events 9 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.8%
2/114 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
5.0%
5/100 • Number of events 8 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
4.8%
5/105 • Number of events 5 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/109 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.00%
0/114 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
4.0%
4/100 • Number of events 4 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
5.7%
6/105 • Number of events 6 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
3/109 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
6.1%
7/114 • Number of events 7 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
3.0%
3/100 • Number of events 3 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
0.95%
1/105 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
|
Infections and infestations
Influenza
|
1.8%
2/109 • Number of events 2 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
5.3%
6/114 • Number of events 6 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
1.0%
1/100 • Number of events 4 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
3.8%
4/105 • Number of events 4 • DBP D0 to the last dose of study medication at Month 24 (OLP) ±14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place