Trial Outcomes & Findings for Investigation of a New Stoma Product for People With a Stoma (NCT NCT04101318)

Last Updated: 2023-09-21

Results Overview

Participant were asked to rate their itching around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible peristomal skin itch. The primary outcome measure was done on the Intended to Treat population. Steady state period of the treatment period began after three weeks of product use.

Recruitment status

COMPLETED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

Within a week at steady state

Results posted on

2023-09-21

Participant Flow

79 participants were recruited from six sites across four countries (UK, Germany, Italy, and Norway) and encompassed the safety population.

79 recruited participants were randomized. Of those 7 participants were excluded as two participants wanted to be discontinued, one participant had device deficiency leading to an Adverse event, two participants had device deficiency not leading to an Adverse event, one participant had an adverse event, and one participant was discontinued due to other reasons. So 72 participants constituted the intention to treat (ITT) population.

Participant milestones

Participant milestones
Measure	The Non-Conformité Européene Marked Product, Then a Conformité Européene Marked Product Participants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days.	A Conformité Européene Marked Product, Then the Non-Conformité Européene Marked Product Participants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days.
First Intervention (42 +/- 3 Days) STARTED	34	38
First Intervention (42 +/- 3 Days) Received Allocated Intervention	34	36
First Intervention (42 +/- 3 Days) COMPLETED	34	36
First Intervention (42 +/- 3 Days) NOT COMPLETED	0	2
Second Intervention (42 +/- 3 Days) STARTED	34	36
Second Intervention (42 +/- 3 Days) Received Allocated Intervention	33	35
Second Intervention (42 +/- 3 Days) COMPLETED	33	35
Second Intervention (42 +/- 3 Days) NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	The Non-Conformité Européene Marked Product, Then a Conformité Européene Marked Product Participants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days.	A Conformité Européene Marked Product, Then the Non-Conformité Européene Marked Product Participants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days.
First Intervention (42 +/- 3 Days) Lost to Follow-up	0	1
First Intervention (42 +/- 3 Days) Adverse Event	0	1
Second Intervention (42 +/- 3 Days) Device deficiency not leading to an adverse event	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total ITT Population Baseline Measures n=72 Participants Arm 1: Participants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days. Arm 2: Participants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days.
Age, Continuous	55.8 years STANDARD_DEVIATION 12.9 • n=72 Participants
Sex: Female, Male Female	37 Participants n=72 Participants
Sex: Female, Male Male	35 Participants n=72 Participants
Region of Enrollment Norway	13 participants n=72 Participants
Region of Enrollment Germany	35 participants n=72 Participants
Region of Enrollment Italy	2 participants n=72 Participants
Region of Enrollment United Kingdom	22 participants n=72 Participants
Weight (kg)	80.5 kg STANDARD_DEVIATION 21.0 • n=72 Participants
Height (cm)	170.4 cm STANDARD_DEVIATION 11.3 • n=72 Participants
BMI (kg/cm^2)	27.6 kg/cm^2 STANDARD_DEVIATION 6.3 • n=72 Participants
Stoma age	11.2 years STANDARD_DEVIATION 10.9 • n=72 Participants
Type of stoma Colostomy	15 Participants n=72 Participants
Type of stoma Ileostomy	57 Participants n=72 Participants

PRIMARY outcome

Timeframe: Within a week at steady state

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Max Itching Within a Week at Steady State	2.5 score on a scale Interval 2.0 to 3.0	2.4 score on a scale Interval 1.9 to 2.9

SECONDARY outcome

Timeframe: past 14 days by end of treatment

Population: The intention to treat population (full analysis set) was constituted by all randomized subjects with a valid informed consent who have been exposed to at least one product, and with valid information on at least one product with respect to the endpoints. The Outcome Measure Data Table depict (seen below) the percentages of total from the statistical data model analyzing 67 participants with measurements in at least one of the arms/groups.

Participants were asked how often they had experienced itchy skin around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: "None of the time", "A little of the time", Some of the time", A lot of the time", and "All of the time". The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as "how many percentages are the answers from one category out of a total of 100% (all the answers)?".

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=58 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=60 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment None of the time	22 percentage of participants	22 percentage of participants
Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment A little of the time	37 percentage of participants	22 percentage of participants
Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment Some of the time	25 percentage of participants	29 percentage of participants
Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment A lot of the time	16 percentage of participants	24 percentage of participants
Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment All of the time	0 percentage of participants	3 percentage of participants

SECONDARY outcome

Timeframe: Within one week at steady state

Participant were asked to rate their pain around the ostomy on a scale of 0-10 with 0= no pain ad 10= worst possible pain. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Max Pain Within a Week at Steady State	1.4 score on a scale Interval 0.9 to 1.9	1.7 score on a scale Interval 1.3 to 2.2

SECONDARY outcome

Timeframe: past 14 days by end of treatment

Participants were asked how often they had experienced pain around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: "None of the time", "A little of the time", Some of the time", A lot of the time", and "All of the time". The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as "how many percentages are the answers from one category out of a total of 100% (all the answers)?".

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=58 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=60 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment A lot of the time	6 percentage of participants	4 percentage of participants
Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment None of the time	45 percentage of participants	43 percentage of participants
Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment A little of the time	39 percentage of participants	33 percentage of participants
Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment Some of the time	10 percentage of participants	20 percentage of participants
Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment All of the time	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Within one week at steady state

Participant were asked to rate burning around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible burning sensation. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Max Burning Within a Week at Steady State	1.8 score on a scale Interval 1.3 to 2.3	2.0 score on a scale Interval 1.5 to 2.5

SECONDARY outcome

Timeframe: past 14 days by end of treatment

Participants were asked how often they had experienced a burning sensation around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: "None of the time", "A little of the time", Some of the time", A lot of the time", and "All of the time". The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as "how many percentages are the answers from one category out of a total of 100% (all the answers)?".

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=58 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=60 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment None of the time	37 percentage of participants	39 percentage of participants
Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment A little of the time	39 percentage of participants	27 percentage of participants
Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment Some of the time	16 percentage of participants	22 percentage of participants
Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment A lot of the time	8 percentage of participants	10 percentage of participants
Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment All of the time	0 percentage of participants	2 percentage of participants

SECONDARY outcome

Timeframe: Within one week at steady state

Participant were asked if they had experienced bleeding around the ostomy within 1 week. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Bleeding Around the Ostomy at Each Baseplate Change at Steady State	0.38 Mean odds, marginal Interval 0.27 to 0.52	0.46 Mean odds, marginal Interval 0.34 to 0.62

SECONDARY outcome

Timeframe: Within one week at steady state

Participant were asked if they had experienced weeping around the ostomy within 1 week. Steady state period of the treatment period begins after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Weeping Around the Ostomy at Each Baseplate Change at Steady State	0.38 Mean odds, marginal Interval 0.26 to 0.56	0.46 Mean odds, marginal Interval 0.32 to 0.65

SECONDARY outcome

Timeframe: Within one week at steady state

Participant were asked if they had experienced ulcers around the ostomy within 1 week. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Ulcers Around the Ostomy at Each Baseplate Change at Steady State	0.40 Mean odds, marginal Interval 0.27 to 0.58	0.57 Mean odds, marginal Interval 0.41 to 0.8

SECONDARY outcome

Timeframe: Within one week at steady state

Participant were asked to rate their overall physical discomfort around the ostomy on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Max Overall Physical Discomfort Within a Week Per Baseplate Change at Steady State	1.9 score on a scale Interval 1.4 to 2.4	1.8 score on a scale Interval 1.3 to 2.3

SECONDARY outcome

Timeframe: Within one week at steady state

Participant were asked to rate their overall ability to move around on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Max Overall Ability to Move Around Within a Week Per Baseplate Change at Steady State	1.3 score on a scale Interval 0.9 to 1.8	1.3 score on a scale Interval 0.8 to 1.7

SECONDARY outcome

Timeframe: Within one week at steady state

Participant were asked to rate the overall ability to stick the stoma bag adhesive to their skin since last change of product on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Max Overall Ability to Stick the Stoma Bag Adhesive to the Skin Within a Week Per Baseplate Change at Steady State	0.8 score on a scale Interval 0.4 to 1.2	0.9 score on a scale Interval 0.5 to 1.3

SECONDARY outcome

Timeframe: 3 weeks

Participant were asked to take photos of their peristomal skin at each baseplate change. The discoloration area of the peristomal skin was determined using an algorithm. The algorithm estimated the area of the discolored skin (divided into three different zones). Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Discoloration Area (cm^2) Per Baseplate Change at Steady State	18.5 cm^2 Interval 15.4 to 21.7	17.2 cm^2 Interval 14.1 to 20.3

SECONDARY outcome

Timeframe: 3 weeks

Photos of the peristomal skin was taken at each baseplate change. The intensity was determined with an overlay to the artificial intelligence algorithm. The overlay divided the area into ten different intensity intervals: "Intensity interval 1"=0-10 …., "Intensity interval 10"=91-100% redness. The score was then calculated as follows: 1\*(Interval 1 measurement)..+ 10\*(Interval 10 measurement). Thus, if the area was within the first interval (0-10% redness) it was multiplied with 1 or within Interval 10 it was multiplied with 10, resulting in a intensity score for the total area. If there is no discoloration the score is 0, and there is no theoretical maximum. A large score equals a high intensity on the skin. In the description of the endpoint (appendix. 1 in CIP), it was to be determined in the inner and outer zone per baseplate change at steady state. However, the algorithm only estimated a total intensity score; thus, the intensity will not be reported per inner and outer zone.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=59 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=65 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Intensity of Discolorated Area Scored Per Baseplate Change at Steady State After Three Weeks of Product Use	107.1 Total intensity area score (cm^2) Interval 84.6 to 129.5	95.4 Total intensity area score (cm^2) Interval 73.4 to 117.3

SECONDARY outcome

Timeframe: 3 weeks

Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. They determined the discoloration, erosion, and tissue overgrowth domain by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected by each domain. Each three domains contributes to the calculation of the total Discoloration, Erosion and Tissue overgrowth score (DET) going from a scale of 0 to 15 ("Normal skin" (DET=0), "Mild" (DET=2- 3), "Moderate" (DET=4- 6), and "Severe" (7-15)). Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=69 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=70 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Total Discoloration, Erosion, and Tissue Overgrowth (DET) Score by End of Treatment at Steady State	3.5 score on a scale Interval 2.9 to 4.2	3.8 score on a scale Interval 3.2 to 4.5

SECONDARY outcome

Timeframe: 3 weeks

Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Discoloration is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15. The discoloration domain was scored by area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and the scores were added together for a total discoloration score (with the max total score being 5). The area is assessed first and if this is 0 then the score for discoloration is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more discolored skin. Steady state period of the treatment period began after three weeks of product use

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=69 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=70 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Discoloration Item Score by End of Treatment at Steady State	2.4 score on a scale Interval 2.1 to 2.8	2.6 score on a scale Interval 2.3 to 2.9

SECONDARY outcome

Timeframe: 3 weeks

Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Erosion is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15.The erosion domain was determined by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and then adding the scores together for a total score (with the max total score being 5). The area is assessed first and if this is 0 then the score for erosion is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more eroded skin. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=69 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=70 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Erosion Item Score by End of Treatment at Steady State	0.7 score on a scale Interval 0.4 to 1.0	0.9 score on a scale Interval 0.6 to 1.2

SECONDARY outcome

Timeframe: 3 weeks

Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Tissue overgrowth is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15. The Tissue Overgrowth domain was assessed by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and then adding the scores together for a total score (with the max total score being 5). The area is assessed first and if this is 0 then the score for tissue overgrowth is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more tissue overgrowth. Steady state period of the treatment period began after three weeks of product use.

Outcome measures

Outcome measures
Measure	Non-Conformité Européene Marked Investigational Baseplate Change n=69 Participants The assessment was done after a baseplate change with the non-Conformité Européene marked investigational product	Conformité Européene Marked Comparator Baseplate Change n=70 Participants The assessment was done after a baseplate change with one of the five Conformité Européene marked comparator products
Tissue Overgrowth Item Score by End of Treatment at Steady State	0.3 score on a scale Interval 0.1 to 0.6	0.3 score on a scale Interval 0.1 to 0.6

Adverse Events

Non-Conformité Européene Marked Product

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Conformité Européene Marked Products

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Total Safety Population

Serious events: 5 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non-Conformité Européene Marked Product n=74 participants at risk Product is not named at this point	Conformité Européene Marked Products n=73 participants at risk 1-piece and 2-piece stoma devices already on the market.	Total Safety Population n=79 participants at risk This arm/group constitutes the safety population
Gastrointestinal disorders Ileus	0.00% 0/74 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	0.00% 0/73 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	1.3% 1/79 • Number of events 1 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.
Gastrointestinal disorders Exacerbated cystic fibrosis	0.00% 0/74 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	0.00% 0/73 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	1.3% 1/79 • Number of events 1 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.
Cardiac disorders Heart attack	0.00% 0/74 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	0.00% 0/73 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	1.3% 1/79 • Number of events 1 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.
Immune system disorders Guillain-barre syndrome	0.00% 0/74 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	0.00% 0/73 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	1.3% 1/79 • Number of events 1 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.
Infections and infestations Feeding line infection	0.00% 0/74 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	0.00% 0/73 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.	1.3% 1/79 • Number of events 1 • Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.

Other adverse events

Additional Information

Vice President, Medical Affairs

Coloplast

Phone: +45 4911 1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60