Trial Outcomes & Findings for An Investigation of Ostomy Devices (NCT NCT01514136)
NCT ID: NCT01514136
Last Updated: 2015-03-11
Results Overview
The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
One week
Results posted on
2015-03-11
Participant Flow
The subject were recruited through the Coloplast A/S user database in Denmark.
The investigation consisted of two periods: in the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts, Test A\*-D\*, were developed and tested. The test products were not randomised. The test order in first round was Test A - Test D and in second round it was Test A\*-Test D\*.
Participant milestones
| Measure |
Test A
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test A was a newly developed concept by Coloplast A/S for the first round.
|
Test B
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test B was a newly developed concept by Coloplast A/S for the first round.
|
Test C
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test C was a newly developed concept by Coloplast A/S for the first round.
|
Test D
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test D was a newly developed concept by Coloplast A/S for the first round.
|
Test A*
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test A\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test B*
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test B\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test C*
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test C\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test D*
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test D\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
|---|---|---|---|---|---|---|---|---|
|
Test Period 1; Test A
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test A
STARTED
|
25
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test A
COMPLETED
|
22
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test B
STARTED
|
0
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test B
COMPLETED
|
0
|
23
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test B
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test C
STARTED
|
0
|
0
|
24
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test C
COMPLETED
|
0
|
0
|
24
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test C
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test D
STARTED
|
0
|
0
|
0
|
26
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test D
COMPLETED
|
0
|
0
|
0
|
24
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test D
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Test Period 2; Test A*
STARTED
|
0
|
0
|
0
|
0
|
28
|
0
|
0
|
0
|
|
Test Period 2; Test A*
COMPLETED
|
0
|
0
|
0
|
0
|
26
|
0
|
0
|
0
|
|
Test Period 2; Test A*
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Test Period 2; Test B*
STARTED
|
0
|
0
|
0
|
0
|
0
|
28
|
0
|
0
|
|
Test Period 2; Test B*
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
26
|
0
|
0
|
|
Test Period 2; Test B*
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Test Period 2; Test C*
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
0
|
|
Test Period 2; Test C*
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
0
|
|
Test Period 2; Test C*
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Test Period; Test D*
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
|
Test Period; Test D*
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
|
Test Period; Test D*
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test A
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test A was a newly developed concept by Coloplast A/S for the first round.
|
Test B
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test B was a newly developed concept by Coloplast A/S for the first round.
|
Test C
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test C was a newly developed concept by Coloplast A/S for the first round.
|
Test D
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test D was a newly developed concept by Coloplast A/S for the first round.
|
Test A*
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test A\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test B*
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test B\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test C*
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test C\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test D*
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Therefore the participant flow is divided by the test products and not for each period.
Test D\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
|---|---|---|---|---|---|---|---|---|
|
Test Period 1; Test A
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test A
Break from study holiday
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test B
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1; Test D
Subject took a break due to holiday
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Test Period 2; Test A*
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Test Period 2; Test A*
Holiday
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Test Period 2; Test B*
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Test Period 2; Test C*
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Test Period 2; Test C*
holiday
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Test Period 2; Test C*
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
An Investigation of Ostomy Devices
Baseline characteristics by cohort
| Measure |
Convex Product Users
n=23 Participants
Subjects who usually use a convex product
|
Flat Product Users
n=9 Participants
Subjects who usually use a flat product
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
64.4 years
STANDARD_DEVIATION 7.5 • n=107 Participants
|
60.8 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: One weekThe degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S
Outcome measures
| Measure |
Test A - Convex Product Users
n=99 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test A was a newly developed concept by Coloplast A/S for the first round.
|
Test B - Convex Product Users
n=98 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test B was a newly developed concept by Coloplast A/S for the first round.
|
Test C - Convex Product Users
n=111 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test C was a newly developed concept by Coloplast A/S for the first round.
|
Test D - Convex Product Users
n=92 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test D was a newly developed concept by Coloplast A/S for the first round.
|
Test A* - Convex Product Users
n=104 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test A\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test B* - Convex Product Users
n=89 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test B\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test C* - Convex Product Users
n=87 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test C\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test D* - Convex Product Users
n=86 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test D\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test A - Flat Product Users
n=36 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test A was a newly developed concept by Coloplast A/S for the first round.
|
Test B - Flat Product Users
n=32 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test B was a newly developed concept by Coloplast A/S for the first round.
|
Test C - Flat Product Users
n=31 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test C was a newly developed concept by Coloplast A/S for the first round.
|
Test D - Flat Product Users
n=43 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test D was a newly developed concept by Coloplast A/S for the first round.
|
Test A* - Flat Product Users
n=43 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test A\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test B* - Flat Product Users
n=42 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test B\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test C* - Flat Product Users
n=41 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test C\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test D* - Flat Product Users
n=35 baseplates
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A\* - D\*.
Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.
Test D\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Degree of Leakage
|
4.2 units on a scale
Standard Deviation 0.6
|
4.3 units on a scale
Standard Deviation 0.8
|
4.4 units on a scale
Standard Deviation 0.7
|
4.3 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.7
|
2.9 units on a scale
Standard Deviation 0.6
|
3.3 units on a scale
Standard Deviation 0.7
|
4.1 units on a scale
Standard Deviation 0.8
|
2.1 units on a scale
Standard Deviation 1.4
|
0.1 units on a scale
Standard Deviation 0.04
|
0.1 units on a scale
Standard Deviation 0.1
|
2.4 units on a scale
Standard Deviation 1.3
|
3.1 units on a scale
Standard Deviation 1.5
|
3.6 units on a scale
Standard Deviation 1.8
|
3.8 units on a scale
Standard Deviation 1.8
|
3.0 units on a scale
Standard Deviation 1.6
|
Adverse Events
Test A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Test B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Test C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Test D
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test A*
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Test B*
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test C*
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Test D*
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test A
n=26 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test A was a newly developed concept by Coloplast A/S for the first round.
|
Test B
n=24 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test B was a newly developed concept by Coloplast A/S for the first round.
|
Test C
n=24 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test C was a newly developed concept by Coloplast A/S for the first round.
|
Test D
n=26 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test D was a newly developed concept by Coloplast A/S for the first round.
|
Test A*
n=28 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test A\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test B*
n=28 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test B\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test C*
n=26 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test C\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test D*
n=23 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test D\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chemotherapy, cancer in lymph nodes
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
0.00%
0/26
|
0.00%
0/23
|
Other adverse events
| Measure |
Test A
n=26 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test A was a newly developed concept by Coloplast A/S for the first round.
|
Test B
n=24 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test B was a newly developed concept by Coloplast A/S for the first round.
|
Test C
n=24 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test C was a newly developed concept by Coloplast A/S for the first round.
|
Test D
n=26 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test D was a newly developed concept by Coloplast A/S for the first round.
|
Test A*
n=28 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test A\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test B*
n=28 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test B\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test C*
n=26 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test C\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
Test D*
n=23 participants at risk
The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A\* - D\*.
Test D\* was a newly developed optimized concept by Coloplast A/S for the second round.
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Perstomal skin irritation
|
7.7%
2/26 • Number of events 2
|
16.7%
4/24 • Number of events 4
|
12.5%
3/24 • Number of events 3
|
7.7%
2/26 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
0.00%
0/26
|
4.3%
1/23 • Number of events 2
|
|
Infections and infestations
Cold or influenza
|
15.4%
4/26 • Number of events 4
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/28
|
10.7%
3/28 • Number of events 3
|
0.00%
0/26
|
0.00%
0/23
|
|
General disorders
Headache
|
3.8%
1/26 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
0.00%
0/26
|
0.00%
0/23
|
|
Investigations
Protocol deviation/not defined
|
3.8%
1/26 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, therapy
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Infection, tooth
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
3.6%
1/28 • Number of events 1
|
0.00%
0/28
|
0.00%
0/26
|
0.00%
0/23
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver values, increased
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/28
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
0.00%
0/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place