Trial Outcomes & Findings for Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) (NCT NCT00585312)
NCT ID: NCT00585312
Last Updated: 2021-02-21
Results Overview
Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events: 1. Appearance of ≥20 polyps (\>2 mm in size) at any colonoscopy during the study (Polyps); or 2. Diagnosis of colorectal malignancy (ColMal).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
5 years
Results posted on
2021-02-21
Participant Flow
A total of 305 participants were screened, whereof 106 were randomized into the study, and of whom 101 took at least 1 dose of study drug. The clinical study was conducted in 18 centers across 13 countries: Belgium, Czech Republic, Hong Kong, Hungary, Israel, Italy, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, and United States.
The randomization was to be stratified by center, age (≥12 years old versus \<12 years old), and familial adenomatous polyposis (FAP) phenotype (negative versus positive). The participants were randomized 1:1 to one of the 2 treatments celecoxib or placebo.
Participant milestones
| Measure |
Celecoxib
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
51
|
|
Overall Study
Treated
|
53
|
48
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
51
|
44
|
Reasons for withdrawal
| Measure |
Celecoxib
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
Matching placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
6
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Reason not specified
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Study terminated by the sponsor
|
34
|
31
|
Baseline Characteristics
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
Baseline characteristics by cohort
| Measure |
Celecoxib
n=55 Participants
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
n=51 Participants
Matching placebo
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.6 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
12.2 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
12.4 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Primary outcome measure was met by 7 (Polyp:7,ColMal:0) participants in the Celecoxib group and 13 (13,0) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.
Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events: 1. Appearance of ≥20 polyps (\>2 mm in size) at any colonoscopy during the study (Polyps); or 2. Diagnosis of colorectal malignancy (ColMal).
Outcome measures
| Measure |
Celecoxib
n=7 Participants
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
n=13 Participants
Matching placebo
|
|---|---|---|
|
Time to Disease Progression
|
2.2 years
Standard Deviation 1.08
|
1.8 years
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Secondary outcome measure was met by 14 (Polyp:7,ColMal:0,DO:14) participants in the Celecoxib and 14 (13,0,12) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.
Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following: * Appearance of ≥20 polyps (\>2 mm in size) at any colonoscopy during the study (Polyps), or * Diagnosis of colorectal malignancy (ColMal), or * Treatment related dropout (DO). The treatment related dropout was defined as insufficient clinical response, progression of disease, death, adverse event, treatment-related laboratory abnormality, subject no longer willing to participate in study, and other reasons that might be related to treatment as determined by treating physicians in a blind fashion before database release.
Outcome measures
| Measure |
Celecoxib
n=14 Participants
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
n=14 Participants
Matching placebo
|
|---|---|---|
|
Time to Treatment Failure
|
2.0 years
Standard Deviation 1.12
|
1.7 years
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Years 1 - 5Population: ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.
Total number of colorectal polyps \>2 mm in size, that were detected over Years 1 - 5 cumulatively. Weighted total number of colorectal polyps over Years 1 - 5 cumulatively was defined as the total number of colorectal polyps \>2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study.
Outcome measures
| Measure |
Celecoxib
n=55 Participants
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
n=51 Participants
Matching placebo
|
|---|---|---|
|
Total Number of Colorectal Polyps
Year 3 (N: 16, 14)
|
13.4 polyps
Standard Deviation 11.31
|
22.3 polyps
Standard Deviation 11.74
|
|
Total Number of Colorectal Polyps
Year 1 (N: 27, 30)
|
3.0 polyps
Standard Deviation 2.68
|
8.1 polyps
Standard Deviation 7.32
|
|
Total Number of Colorectal Polyps
Year 2 (N: 21, 25)
|
8.8 polyps
Standard Deviation 6.63
|
13.7 polyps
Standard Deviation 10.51
|
|
Total Number of Colorectal Polyps
Year 4 (N: 8, 7)
|
18.6 polyps
Standard Deviation 17.65
|
36.4 polyps
Standard Deviation 22.50
|
|
Total Number of Colorectal Polyps
Year 5 (N: 2, 2)
|
30.5 polyps
Standard Deviation 21.92
|
46.5 polyps
Standard Deviation 34.65
|
|
Total Number of Colorectal Polyps
Years 1 - 5 cumulatively (N: 33, 36)
|
4.3 polyps
Standard Deviation 3.58
|
8.6 polyps
Standard Deviation 7.12
|
SECONDARY outcome
Timeframe: Years 1 - 5Population: ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.
The polyp burden was defined as the sum of the largest diameters of all polyps (\>2 mm in size) over Years 1 - 5 cumulatively. Weighted colorectal polyp burden over Years 1 - 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study.
Outcome measures
| Measure |
Celecoxib
n=55 Participants
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
n=51 Participants
Matching placebo
|
|---|---|---|
|
Colorectal Polyp Burden
Year 4 (N: 8, 7)
|
12.9 mm
Standard Deviation 3.31
|
18.7 mm
Standard Deviation 5.88
|
|
Colorectal Polyp Burden
Year 1 (N: 27, 30)
|
4.0 mm
Standard Deviation 1.97
|
4.2 mm
Standard Deviation 2.05
|
|
Colorectal Polyp Burden
Year 2 (N: 21, 25)
|
6.9 mm
Standard Deviation 2.28
|
8.1 mm
Standard Deviation 4.06
|
|
Colorectal Polyp Burden
Year 3 (N: 16, 14)
|
9.6 mm
Standard Deviation 3.14
|
11.6 mm
Standard Deviation 4.05
|
|
Colorectal Polyp Burden
Year 5 (N: 2, 2)
|
20.0 mm
Standard Deviation 7.07
|
20.0 mm
Standard Deviation 4.24
|
|
Colorectal Polyp Burden
Year 1 - 5 cumulatively (N: 33, 36)
|
4.1 mm
Standard Deviation 1.68
|
4.3 mm
Standard Deviation 1.61
|
Adverse Events
Celecoxib
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Celecoxib
n=53 participants at risk
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
n=48 participants at risk
Matching placebo
|
|---|---|---|
|
Infections and infestations
Periorbital cellulitis
|
1.9%
1/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
1.9%
1/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Celecoxib
n=53 participants at risk
Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
|
Placebo
n=48 participants at risk
Matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
17.0%
9/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
4/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.0%
9/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.8%
10/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
4/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.2%
3/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
6/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
4/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
15.1%
8/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
16.7%
8/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.8%
2/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.2%
3/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
9/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
18.8%
9/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
7.5%
4/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
11.3%
6/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
4/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
3.8%
2/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.4%
5/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Ear infection
|
7.5%
4/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
5.7%
3/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
5.7%
3/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
11.3%
6/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
6/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
4/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
4/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
18.8%
9/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
4/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Albumin urine present
|
5.7%
3/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
3/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.2%
2/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
2/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.4%
5/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
30.2%
16/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
29.2%
14/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Migraine
|
3.8%
2/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
4/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.1%
8/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
12.5%
6/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
3/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.1%
1/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.2%
3/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.3%
6/53 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.4%
5/48 • Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER