Trial Outcomes & Findings for Phase III Cat-PAD Follow-on Study (NCT NCT02040844)
NCT ID: NCT02040844
Last Updated: 2018-06-15
Results Overview
The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007). CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3. AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
430 participants
Primary outcome timeframe
1 year after completing CP007
Results posted on
2018-06-15
Participant Flow
Participant milestones
| Measure |
Cat-PAD Treatment 1 (1 Course)
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
138
|
148
|
144
|
|
Overall Study
COMPLETED
|
88
|
109
|
97
|
|
Overall Study
NOT COMPLETED
|
50
|
39
|
47
|
Reasons for withdrawal
| Measure |
Cat-PAD Treatment 1 (1 Course)
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
16
|
22
|
25
|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
13
|
|
Overall Study
Missing
|
13
|
3
|
2
|
|
Overall Study
Non-specified
|
8
|
2
|
5
|
|
Overall Study
Concomitant medication
|
1
|
3
|
1
|
Baseline Characteristics
Phase III Cat-PAD Follow-on Study
Baseline characteristics by cohort
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=138 Participants
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=148 Participants
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=144 Participants
Placebo - 1 dose every 4 weeks
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
133 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
405 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
292 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
135 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
419 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian (Indian)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian (Oriental)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 Subjects
n=5 Participants
|
30 Subjects
n=7 Participants
|
41 Subjects
n=5 Participants
|
102 Subjects
n=4 Participants
|
|
Region of Enrollment
Europe
|
68 Subjects
n=5 Participants
|
82 Subjects
n=7 Participants
|
68 Subjects
n=5 Participants
|
218 Subjects
n=4 Participants
|
|
Region of Enrollment
Canada
|
39 Subjects
n=5 Participants
|
36 Subjects
n=7 Participants
|
35 Subjects
n=5 Participants
|
110 Subjects
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 year after completing CP007Population: The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).
The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007). CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3. AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6.
Outcome measures
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=88 Participants
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=109 Participants
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=97 Participants
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])
|
1.99 units on a scale
Standard Error 0.16
|
1.91 units on a scale
Standard Error 0.15
|
1.93 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 1 year after completion of CP007Population: The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).
Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo. Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the first study (CP007).
Outcome measures
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=88 Participants
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=109 Participants
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=97 Participants
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Mean TRSS
|
12.95 units on a scale
Standard Error 0.69
|
13.15 units on a scale
Standard Error 0.66
|
12.92 units on a scale
Standard Error 0.67
|
SECONDARY outcome
Timeframe: 1 year after completion of CP007Population: The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).
TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks 1 year after completing the original CP007 study.
Outcome measures
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=88 Participants
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=109 Participants
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=97 Participants
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Mean Component Scores of the TRSS (Nasal)
|
7.06 units on a scale
Standard Error 0.39
|
7.17 units on a scale
Standard Error 0.37
|
6.96 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: 1 year after completion of CP007Population: The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).
Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the original CP007 study
Outcome measures
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=88 Participants
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=109 Participants
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=97 Participants
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Mean Component Scores of the TRSS (Ocular)
|
5.90 units on a scale
Standard Error 0.35
|
5.97 units on a scale
Standard Error 0.33
|
6.00 units on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: 1 year after completion of CP007Population: The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).
Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive.
Outcome measures
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=88 Participants
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=109 Participants
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=97 Participants
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Mean Allergy Medication Score (AMS)
|
0.37 units on a scale
Standard Error 0.09
|
0.27 units on a scale
Standard Error 0.09
|
0.31 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 1 year after completion of CP007Population: The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).
The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007). The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six. A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome.
Outcome measures
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=88 Participants
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=109 Participants
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=97 Participants
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Mean RQLQ Score
|
1.58 units on a scale
Standard Error 0.22
|
1.62 units on a scale
Standard Error 0.21
|
1.51 units on a scale
Standard Error 0.22
|
Adverse Events
Cat-PAD Treatment 1 (1 Course)
Serious events: 3 serious events
Other events: 54 other events
Deaths: 0 deaths
Cat-PAD Treatment (2 Courses)
Serious events: 4 serious events
Other events: 62 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=138 participants at risk
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=148 participants at risk
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=144 participants at risk
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.68%
1/148 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.69%
1/144 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Immune system disorders
Anapylactic reaction
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.69%
1/144 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.68%
1/148 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Gastrointestinal disorders
Colonic fistula
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.69%
1/144 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.68%
1/148 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Colonic abscess
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Gastronteritis Escheria coli
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Viral infection
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.68%
1/148 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/144 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
Other adverse events
| Measure |
Cat-PAD Treatment 1 (1 Course)
n=138 participants at risk
Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks
|
Cat-PAD Treatment (2 Courses)
n=148 participants at risk
Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks
|
Placebo
n=144 participants at risk
Placebo - 1 dose every 4 weeks
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.9%
15/138 • Number of events 19 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
13.5%
20/148 • Number of events 30 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
12.5%
18/144 • Number of events 36 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Sinusitis
|
4.3%
6/138 • Number of events 6 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
4.1%
6/148 • Number of events 9 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
3.5%
5/144 • Number of events 7 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Influenza
|
3.6%
5/138 • Number of events 8 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.7%
4/148 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
4.9%
7/144 • Number of events 11 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
2/138 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
1.4%
2/148 • Number of events 2 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
5.6%
8/144 • Number of events 10 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Bronchitis
|
2.9%
4/138 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.7%
4/148 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
1.4%
2/144 • Number of events 2 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Tonsillitis
|
2.2%
3/138 • Number of events 3 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.0%
3/148 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
1.4%
2/144 • Number of events 2 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Pharyngitis
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.7%
4/148 • Number of events 5 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.69%
1/144 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Conjunctivitis
|
2.2%
3/138 • Number of events 3 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.68%
1/148 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.69%
1/144 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.1%
3/144 • Number of events 3 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.1%
3/144 • Number of events 6 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
5/138 • Number of events 6 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
1.4%
2/148 • Number of events 2 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
3.5%
5/144 • Number of events 5 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
2/138 • Number of events 2 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.0%
3/148 • Number of events 3 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
4.2%
6/144 • Number of events 6 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.7%
4/148 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.1%
3/144 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
2/138 • Number of events 2 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.00%
0/148 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.1%
3/144 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Gastrointestinal disorders
Nausea
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.7%
4/148 • Number of events 4 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.1%
3/144 • Number of events 5 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Gastrointestinal disorders
Abdominal pain
|
0.72%
1/138 • Number of events 2 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.68%
1/148 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.1%
3/144 • Number of events 3 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Nervous system disorders
Headache
|
3.6%
5/138 • Number of events 21 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
4.1%
6/148 • Number of events 6 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
4.2%
6/144 • Number of events 7 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Nervous system disorders
Migraine
|
0.72%
1/138 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.68%
1/148 • Number of events 2 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
4.2%
6/144 • Number of events 7 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/138 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
0.68%
1/148 • Number of events 1 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
2.1%
3/144 • Number of events 3 • Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee To avoid disclosures that may affect the proprietary rights of the Sponsor, the Investigator agrees to allow Circassia the opportunity to review all manuscripts and abstracts 60 days prior to submission for publication. Circassia reserves the right to include the report of this study in any regulatory documentation or submission or in any informational materials.
- Publication restrictions are in place
Restriction type: OTHER