Trial Outcomes & Findings for To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products (NCT NCT04007159)
NCT ID: NCT04007159
Last Updated: 2020-12-10
Results Overview
Human repeated insult patch test (HRIPT) reactions as per (ICDRG) were scored by trained blind evualuator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment of positive reactions was determined by the blinded dermatologist and reported as Yes/ No/ Unable to determine. Percentage of participants with potential sensitization (count of "Yes"/ total reactions) were reported in form of numbers in this outcome measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
302 participants
Primary outcome timeframe
Day 40
Results posted on
2020-12-10
Participant Flow
Participants were recruited from one center in Brazil.
A total of 369 participants were screened, of which 302 participants were enrolled and 280 participants were randomized in induction phase and 258 participants went into the challenge phase.
Participant milestones
| Measure |
Overall Participants
Participants applied a semi-occlusive adhesive patch containing the test products 0.02 milliliters per centimeters square (mL/cm\^2) and 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 minutes (min), test sites were evaluated as per the International Contact Dermatitis Research Group (ICDRG) scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
|---|---|
|
Induction Phase
STARTED
|
280
|
|
Induction Phase
COMPLETED
|
258
|
|
Induction Phase
NOT COMPLETED
|
22
|
|
Rest Phase
STARTED
|
258
|
|
Rest Phase
COMPLETED
|
258
|
|
Rest Phase
NOT COMPLETED
|
0
|
|
Challenge Phase
STARTED
|
258
|
|
Challenge Phase
COMPLETED
|
255
|
|
Challenge Phase
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Overall Participants
Participants applied a semi-occlusive adhesive patch containing the test products 0.02 milliliters per centimeters square (mL/cm\^2) and 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 minutes (min), test sites were evaluated as per the International Contact Dermatitis Research Group (ICDRG) scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
|---|---|
|
Induction Phase
(missed study visits)
|
16
|
|
Induction Phase
Withdrawal by Subject
|
4
|
|
Induction Phase
Adverse Event
|
2
|
|
Challenge Phase
missed study visits
|
3
|
Baseline Characteristics
To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products
Baseline characteristics by cohort
| Measure |
Overall Participants
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing the test products 0.02 mL/cm\^2 and 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
|---|---|
|
Age, Continuous
|
43.4 Years
STANDARD_DEVIATION 12.97 • n=93 Participants
|
|
Sex: Female, Male
Female
|
251 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
241 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Fitzpatrick Skin Type Grading
I - Always burns easily, never tans (pale white skin)
|
6 Number of Participants
n=93 Participants
|
|
Fitzpatrick Skin Type Grading
II - Always burns easily; tans minimally (white skin)
|
53 Number of Participants
n=93 Participants
|
|
Fitzpatrick Skin Type Grading
III - Burns moderately; tans gradually (light brown skin)
|
137 Number of Participants
n=93 Participants
|
|
Fitzpatrick Skin Type Grading
IV - Burns minimally, always tans well (moderate brown skin)
|
84 Number of Participants
n=93 Participants
|
|
Fitzpatrick Skin Type Grading
V - Dark brown skin
|
0 Number of Participants
n=93 Participants
|
|
Fitzpatrick Skin Type Grading
VI - Deeply pigmented dark brown to black skin
|
0 Number of Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 40Population: The Safety Population comprised all randomized participants who received application of any of the study products.Number analyzed in this outcome measure signifies those who were evaluated.
Human repeated insult patch test (HRIPT) reactions as per (ICDRG) were scored by trained blind evualuator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment of positive reactions was determined by the blinded dermatologist and reported as Yes/ No/ Unable to determine. Percentage of participants with potential sensitization (count of "Yes"/ total reactions) were reported in form of numbers in this outcome measure.
Outcome measures
| Measure |
Developmental Serum
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing the developmental serum 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Developmental Lotion
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing the developmental lotion 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Developmental Cream
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing the developmental cream 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Negative Control
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
|---|---|---|---|---|
|
Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40
|
2 Number of participants
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: Day 40Population: The Safety Population comprised all randomized participants who received application of any of the study products.Number analyzed in this outcome measure signifies those who were evaluated.
HRIPT reactions as per ICDRG were scored by trained blind evaluator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment was determined by the blinded dermatologist and reported as a score of '+' or greater. Percentage of participants with any positive reaction (a score of '+' or greater) will be reported in numbers in this outcome measure.
Outcome measures
| Measure |
Developmental Serum
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing the developmental serum 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Developmental Lotion
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing the developmental lotion 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Developmental Cream
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing the developmental cream 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Negative Control
n=280 Participants
Participants applied a semi-occlusive adhesive patch containing 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
|---|---|---|---|---|
|
Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator
Induction Phase
|
4 Number of participants
|
4 Number of participants
|
4 Number of participants
|
4 Number of participants
|
|
Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator
Challenge Phase
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
Adverse Events
Developmental Serum
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Developmental Lotion
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Developmental Cream
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Negative Control
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Overall Participants
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Developmental Serum
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing the developmental serum 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Developmental Lotion
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing the developmental lotion 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Developmental Cream
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing the developmental cream 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Negative Control
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Overall Participants
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing the test products 0.02 mL/cm\^2 and 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Alcohol Poisoining
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
Other adverse events
| Measure |
Developmental Serum
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing the developmental serum 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Developmental Lotion
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing the developmental lotion 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Developmental Cream
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing the developmental cream 0.02 mL/cm\^2 in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Negative Control
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
Overall Participants
n=280 participants at risk
Participants applied a semi-occlusive adhesive patch containing the test products 0.02 mL/cm\^2 and 0.9% NaCl as negative control in an individual cell of the patch topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 (+/-4) hours in weekdays and 72 (+/-4) hours in weekends. Patch was removed and area was gently wiped. After 30 min, test sites were evaluated as per the ICDRG scale. After 2 weeks of rest phase, participants followed the similar procedure with single application for 48 (+/-4) hours in the challenge phase. After 30 min, test sites were evaluated.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
1.4%
4/280 • Number of events 5 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
1.4%
4/280 • Number of events 5 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
1.4%
4/280 • Number of events 5 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
1.4%
4/280 • Number of events 5 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
1.4%
4/280 • Number of events 5 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
|
Gastrointestinal disorders
Food poisoning
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
|
Infections and infestations
Influenza
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
0.36%
1/280 • Number of events 1 • Upto Day 40
The Safety Population included all randomized participants who received at least 1 dose of any study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER