Trial Outcomes & Findings for A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial (NCT NCT00580606)
NCT ID: NCT00580606
Last Updated: 2019-08-21
Results Overview
Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Week 44 (Double Blind Period)
Results posted on
2019-08-21
Participant Flow
Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital from April 2008 to January 2010.
Participant milestones
| Measure |
Low Dose Peanut SLIT (Double Blind to Open Label)
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume \>= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
|
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
|
|---|---|---|
|
Double Blind (DB)
STARTED
|
20
|
20
|
|
Double Blind (DB)
Had Week 44 Oral Food Challenge
|
18
|
19
|
|
Double Blind (DB)
COMPLETED
|
20
|
20
|
|
Double Blind (DB)
NOT COMPLETED
|
0
|
0
|
|
Open Label (OL)
STARTED
|
18
|
17
|
|
Open Label (OL)
Had Week 44 Oral Food Challenge
|
0
|
12
|
|
Open Label (OL)
Had Week 68 Oral Food Challenge
|
15
|
12
|
|
Open Label (OL)
Had Week 116 Oral Food Challenge
|
13
|
6
|
|
Open Label (OL)
Had Week 164 Oral Food Challenge
|
9
|
5
|
|
Open Label (OL)
Had Week 172 Oral Food Challenge
|
2
|
2
|
|
Open Label (OL)
COMPLETED
|
9
|
5
|
|
Open Label (OL)
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
Low Dose Peanut SLIT (Double Blind to Open Label)
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume \>= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
|
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
|
|---|---|---|
|
Open Label (OL)
Lack of Efficacy at Week 116 OFC
|
2
|
1
|
|
Open Label (OL)
Withdrawal by Subject
|
4
|
6
|
|
Open Label (OL)
Dosing Symptoms
|
0
|
1
|
|
Open Label (OL)
Lost to Follow-up
|
0
|
1
|
|
Open Label (OL)
Pregnancy
|
0
|
1
|
|
Open Label (OL)
Non-compliance
|
2
|
0
|
|
Open Label (OL)
Physician Decision
|
1
|
1
|
|
Open Label (OL)
Needed Prohibited Medication
|
0
|
1
|
Baseline Characteristics
A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial
Baseline characteristics by cohort
| Measure |
Low Dose Peanut SLIT (Double Blind to Open Label)
n=20 Participants
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume \>= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
|
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
n=20 Participants
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
17.2 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
16.5 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
16.8 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Atopic Dermatitis Total Score
|
1.1 Scores on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
0.9 Scores on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
1.0 Scores on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Total IgE
|
407.8 kU/L
STANDARD_DEVIATION 254.1 • n=5 Participants
|
330.5 kU/L
STANDARD_DEVIATION 305.0 • n=7 Participants
|
369.1 kU/L
STANDARD_DEVIATION 279.9 • n=5 Participants
|
|
Peanut IgE
|
33.6 kUA/L
STANDARD_DEVIATION 38.1 • n=5 Participants
|
47.1 kUA/L
STANDARD_DEVIATION 58.0 • n=7 Participants
|
40.4 kUA/L
STANDARD_DEVIATION 48.9 • n=5 Participants
|
|
Peanut Skin Prick Test Score
|
14.0 mm
STANDARD_DEVIATION 6.9 • n=5 Participants
|
12.4 mm
STANDARD_DEVIATION 4.6 • n=7 Participants
|
13.2 mm
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Age at Initial Peanut Allergic Reaction
|
4.6 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
1.9 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
3.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 44 (Double Blind Period)Population: The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.
Outcome measures
| Measure |
Low Dose Peanut SLIT (Double Blind)
n=20 Participants
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
|
Placebo (Double Blind)
n=20 Participants
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
|
|---|---|---|
|
Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge
|
70 Percentage of participants
|
15 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 44 (Double Blind Period)Population: The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.
Outcome measures
| Measure |
Low Dose Peanut SLIT (Double Blind)
n=20 Participants
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
|
Placebo (Double Blind)
n=20 Participants
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
|
|---|---|---|
|
Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg
|
85.0 Percentage of participants
|
95.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 44 after initiating crossover open label peanut protein consumptionPopulation: Subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included except for 1 subject who refused the crossover Week 44 OFC and could not be evaluated. 4 subjects who discontinued dosing prior to the crossover Week 44 OFC were counted as failures.
Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.
Outcome measures
| Measure |
Low Dose Peanut SLIT (Double Blind)
n=16 Participants
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
|
Placebo (Double Blind)
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
|
|---|---|---|
|
Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption
|
43.8 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 44 after initiating crossover open label peanut protein consumptionPopulation: All subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included.
During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.
Outcome measures
| Measure |
Low Dose Peanut SLIT (Double Blind)
n=17 Participants
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
|
Placebo (Double Blind)
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
|
|---|---|---|
|
Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg
|
88.2 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 44 (Double Blind Period)Population: The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
Outcome measures
| Measure |
Low Dose Peanut SLIT (Double Blind)
n=20 Participants
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
|
Placebo (Double Blind)
n=20 Participants
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumptionPopulation: All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.
All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.
Outcome measures
| Measure |
Low Dose Peanut SLIT (Double Blind)
n=17 Participants
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
|
Placebo (Double Blind)
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
|
|---|---|---|
|
Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapyPopulation: All subjects randomized to the Low Dose Peanut SLIT group and all subjects randomized to the Placebo group who crossed over to open label high dose peanut sublingual immunotherapy were included.
Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.
Outcome measures
| Measure |
Low Dose Peanut SLIT (Double Blind)
n=20 Participants
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
|
Placebo (Double Blind)
n=17 Participants
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
|
|---|---|---|
|
Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder
|
10.0 percentage of participants
|
11.8 percentage of participants
|
Adverse Events
Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo Before Week 44 OFC (Double Blind)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Low Dose Peanut SLIT (Double Blind to Open Label)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)
n=20 participants at risk
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
|
Placebo Before Week 44 OFC (Double Blind)
n=20 participants at risk
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
|
High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)
n=17 participants at risk
Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for \>= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy
|
Low Dose Peanut SLIT (Double Blind to Open Label)
n=18 participants at risk
After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
|
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
n=17 participants at risk
After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
|
|---|---|---|---|---|---|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
Other adverse events
| Measure |
Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)
n=20 participants at risk
Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
|
Placebo Before Week 44 OFC (Double Blind)
n=20 participants at risk
Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
|
High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)
n=17 participants at risk
Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for \>= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy
|
Low Dose Peanut SLIT (Double Blind to Open Label)
n=18 participants at risk
After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
|
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
n=17 participants at risk
After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 114 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
7.1%
1/14 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Eye disorders
Conjunctivitis allergic
|
10.0%
2/20 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
7.1%
1/14 • Number of events 5 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Eye disorders
Photophobia
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
35.0%
7/20 • Number of events 53 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
35.3%
6/17 • Number of events 33 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 7 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
14.3%
2/14 • Number of events 16 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 11 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
15.0%
3/20 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 10 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
7.1%
1/14 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Oral disorder
|
85.0%
17/20 • Number of events 2171 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
30.0%
6/20 • Number of events 23 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
94.1%
16/17 • Number of events 1579 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
77.8%
14/18 • Number of events 1913 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
57.1%
8/14 • Number of events 1326 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Swollen tongue
|
15.0%
3/20 • Number of events 8 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
10.0%
2/20 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
General disorders
Feeling hot
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
General disorders
Influenza like illness
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
General disorders
Pain
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
16.7%
3/18 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Cystitis
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Ear infection
|
10.0%
2/20 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
10.0%
2/20 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
4/20 • Number of events 6 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
25.0%
5/20 • Number of events 7 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
17.6%
3/17 • Number of events 7 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
16.7%
3/18 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Sinusitis
|
20.0%
4/20 • Number of events 5 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
10.0%
2/20 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
17.6%
3/17 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
16.7%
3/18 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
23.5%
4/17 • Number of events 7 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
4/20 • Number of events 5 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
20.0%
4/20 • Number of events 8 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
17.6%
3/17 • Number of events 6 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
16.7%
3/18 • Number of events 10 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
17.6%
3/17 • Number of events 8 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Infections and infestations
Viral infection
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Joint injury
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
15.0%
3/20 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Lip injury
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal pain
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 5 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
15.0%
3/20 • Number of events 5 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
17.6%
3/17 • Number of events 6 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 6 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.0%
1/20 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
10.0%
2/20 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Number of events 65 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
7.1%
1/14 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
4/20 • Number of events 8 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
7.1%
1/14 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
45.0%
9/20 • Number of events 51 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
15.0%
3/20 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
35.3%
6/17 • Number of events 20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
16.7%
3/18 • Number of events 56 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
7.1%
1/14 • Number of events 259 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.0%
3/20 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
10.0%
2/20 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
2/20 • Number of events 5 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
17.6%
3/17 • Number of events 7 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
21.4%
3/14 • Number of events 7 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.0%
1/20 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
23.5%
4/17 • Number of events 4 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
35.0%
7/20 • Number of events 62 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
15.0%
3/20 • Number of events 7 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.8%
2/17 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
14.3%
2/14 • Number of events 3 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
35.0%
7/20 • Number of events 24 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.0%
1/20 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
35.3%
6/17 • Number of events 34 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
27.8%
5/18 • Number of events 7 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
21.4%
3/14 • Number of events 15 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Surgical and medical procedures
Labial frenectomy
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Surgical and medical procedures
Nasal septal operation
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Surgical and medical procedures
Papilloma excision
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
11.1%
2/18 • Number of events 2 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.6%
1/18 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/17 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/20 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
5.9%
1/17 • Number of events 1 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/18 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
0.00%
0/14 • Baseline through 44 weeks of study therapy
This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place