Trial Outcomes & Findings for A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU). (NCT NCT03137069)
NCT ID: NCT03137069
Last Updated: 2020-09-29
Results Overview
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (Day 57 score minus Baseline score) indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
Baseline and Day 57
Results posted on
2020-09-29
Participant Flow
The study was conducted at 21 centers in 3 countries.
A total of 134 participants were enrolled at 21 centers.
Participant milestones
| Measure |
Cohort 1: Placebo
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
28
|
23
|
23
|
24
|
23
|
|
Overall Study
COMPLETED
|
12
|
22
|
20
|
17
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
3
|
6
|
2
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: Placebo
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Data Entry Error
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
Baseline characteristics by cohort
| Measure |
Cohort 1: Placebo
n=13 Participants
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
n=28 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
n=23 Participants
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
n=23 Participants
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
n=24 Participants
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
n=23 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.6 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
41.3 Years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
40.2 Years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
45.0 Years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
43.3 Years
STANDARD_DEVIATION 16.7 • n=21 Participants
|
44.3 Years
STANDARD_DEVIATION 13.0 • n=8 Participants
|
42.8 Years
STANDARD_DEVIATION 14.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
104 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
116 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
110 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 57Population: The Modified Intent-To-Treat (mITT) Population was defined as all participants who received at least one dose of study treatment grouped for analysis according to the treatment arm to which they were randomized. Data presented below is only for participants included in the actual analysis.
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (Day 57 score minus Baseline score) indicates improvement.
Outcome measures
| Measure |
Cohort 1: Placebo
n=12 Participants
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
n=22 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
n=20 Participants
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
n=19 Participants
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
n=22 Participants
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
n=21 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Day 57
|
-19.16 Score on a Scale
Standard Deviation 13.49
|
-24.05 Score on a Scale
Standard Deviation 9.74
|
-11.25 Score on a Scale
Standard Deviation 10.81
|
-15.69 Score on a Scale
Standard Deviation 14.25
|
-17.05 Score on a Scale
Standard Deviation 10.19
|
-21.80 Score on a Scale
Standard Deviation 14.80
|
SECONDARY outcome
Timeframe: Day 57Population: The Modified Intent-To-Treat (mITT) Population was defined as all participants who received at least one dose of study treatment grouped for analysis according to the treatment arm to which they were randomized. Data presented below is only for participants included in the actual analysis.
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. Participants with UAS7 score ≤6 are considered well controlled.
Outcome measures
| Measure |
Cohort 1: Placebo
n=13 Participants
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
n=28 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
n=23 Participants
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
n=23 Participants
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
n=24 Participants
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
n=23 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Are Well-Controlled (UAS7 ≤ 6)
|
30.8 Percentage of Participants
|
57.1 Percentage of Participants
|
21.7 Percentage of Participants
|
34.8 Percentage of Participants
|
45.8 Percentage of Participants
|
56.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: The Modified Intent-To-Treat (mITT) Population was defined as all participants who received at least one dose of study treatment grouped for analysis according to the treatment arm to which they were randomized. Data presented below is only for participants included in the actual analysis.
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (Day 29 score minus Baseline score) indicates improvement.
Outcome measures
| Measure |
Cohort 1: Placebo
n=13 Participants
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
n=24 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
n=21 Participants
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
n=19 Participants
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
n=23 Participants
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
n=21 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the UAS7 at Day 29
|
-9.69 Score on a Scale
Standard Deviation 10.70
|
-22.15 Score on a Scale
Standard Deviation 10.33
|
-9.05 Score on a Scale
Standard Deviation 9.82
|
-16.97 Score on a Scale
Standard Deviation 14.31
|
-13.75 Score on a Scale
Standard Deviation 12.93
|
-21.69 Score on a Scale
Standard Deviation 16.22
|
SECONDARY outcome
Timeframe: Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).Population: The Safety-evaluable population was defined as all participants who received at least one dose of study drug with participants grouped according to their actual treatment. Due to a data entry error, one participant in the (Cohort 2: Placebo) arm was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm.
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Outcome measures
| Measure |
Cohort 1: Placebo
n=13 Participants
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
n=28 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
n=22 Participants
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
n=23 Participants
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
n=24 Participants
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
n=24 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
61.5 Percentage of Participants
|
71.4 Percentage of Participants
|
54.5 Percentage of Participants
|
60.9 Percentage of Participants
|
66.7 Percentage of Participants
|
58.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Days 1, 8 and 57.Population: The PK-evaluable population was defined as all participants who received at least one dose of fenebrutinib (GDC-0853) and had at least 1 evaluable post-dose PK sample. Participants who received incorrect therapy different from the intended therapy were summarized in the group according to the therapy actually received.
Plasma Concentration Data for fenebrutinib (GDC-0853) will be tabulated and summarised by visits. Descriptive summary statistics for Arithmetic Mean and Standard Deviation will be presented. Please note that the Placebo Cohorts were not evaluated for this Outcome Measure.
Outcome measures
| Measure |
Cohort 1: Placebo
n=28 Participants
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
n=23 Participants
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
n=24 Participants
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
n=23 Participants
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints
Day 1
|
NA ng/mL
Standard Deviation NA
No drug administered at this timepoint.
|
NA ng/mL
Standard Deviation NA
No drug administered at this timepoint.
|
NA ng/mL
Standard Deviation NA
No drug administered at this timepoint.
|
NA ng/mL
Standard Deviation NA
No drug administered at this timepoint.
|
—
|
—
|
|
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints
Day 8
|
378 ng/mL
Standard Deviation 389
|
38.5 ng/mL
Standard Deviation 36.9
|
178 ng/mL
Standard Deviation 237
|
424 ng/mL
Standard Deviation 385
|
—
|
—
|
|
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints
Day 57
|
283 ng/mL
Standard Deviation 315
|
19.6 ng/mL
Standard Deviation 26.3
|
24.7 ng/mL
Standard Deviation 17.7
|
219 ng/mL
Standard Deviation 293
|
—
|
—
|
Adverse Events
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 1: GDC-0853 200mg BID
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: GDC-0853 50mg QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: GDC-0853 150mg QD
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2: GDC-0853 200mg BID
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Placebo
n=13 participants at risk
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
n=28 participants at risk
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
n=22 participants at risk
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
n=23 participants at risk
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
n=24 participants at risk
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
n=24 participants at risk
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
3.6%
1/28 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Infections and infestations
PERIORBITAL CELLULITIS
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
3.6%
1/28 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
3.6%
1/28 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
Other adverse events
| Measure |
Cohort 1: Placebo
n=13 participants at risk
Participants received matching placebo twice daily from Day 1 to 56.
|
Cohort 1: GDC-0853 200mg BID
n=28 participants at risk
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
Cohort 2: Placebo
n=22 participants at risk
Participants received matching placebo up to twice daily from Day 1 to 56.
|
Cohort 2: GDC-0853 50mg QD
n=23 participants at risk
Participants received GDC-0853 50mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 150mg QD
n=24 participants at risk
Participants received GDC-0853 150mg once daily from Day 1 to 56.
|
Cohort 2: GDC-0853 200mg BID
n=24 participants at risk
Participants received GDC-0853 200mg twice daily from Day 1 to 56.
|
|---|---|---|---|---|---|---|
|
Eye disorders
VISION BLURRED
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
3.6%
1/28 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
9.1%
2/22 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.2%
1/24 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
7.1%
2/28 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.3%
1/23 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
8.3%
2/24 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
8.3%
2/24 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
General disorders
CHILLS
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
General disorders
FATIGUE
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
3.6%
1/28 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
9.1%
2/22 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.2%
1/24 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
General disorders
FEELING ABNORMAL
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Infections and infestations
EYE INFECTION
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Infections and infestations
NASOPHARYNGITIS
|
23.1%
3/13 • Number of events 3 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
25.0%
7/28 • Number of events 9 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.5%
1/22 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
13.0%
3/23 • Number of events 3 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
12.5%
3/24 • Number of events 4 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
12.5%
3/24 • Number of events 4 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Infections and infestations
TOOTH INFECTION
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
3.6%
1/28 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.5%
1/22 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
8.3%
2/24 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.3%
1/23 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
8.3%
2/24 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.2%
1/24 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Injury, poisoning and procedural complications
BONE CONTUSION
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
7.1%
2/28 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.2%
1/24 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Injury, poisoning and procedural complications
INJURY
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
7.1%
2/28 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.2%
1/24 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
12.5%
3/24 • Number of events 3 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
7.1%
2/28 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.2%
1/24 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
8.3%
2/24 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Investigations
WEIGHT DECREASED
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/28 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.5%
1/22 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.3%
1/23 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Nervous system disorders
DIZZINESS
|
7.7%
1/13 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
7.1%
2/28 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/22 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.2%
1/24 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Nervous system disorders
HEADACHE
|
23.1%
3/13 • Number of events 3 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
14.3%
4/28 • Number of events 5 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
9.1%
2/22 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.2%
1/24 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
12.5%
3/24 • Number of events 3 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Skin and subcutaneous tissue disorders
CHRONIC SPONTANEOUS URTICARIA
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
7.1%
2/28 • Number of events 3 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.5%
1/22 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
4.3%
1/23 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
8.3%
2/24 • Number of events 3 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
0.00%
0/24 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/13 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
17.9%
5/28 • Number of events 5 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
9.1%
2/22 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
13.0%
3/23 • Number of events 3 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
16.7%
4/24 • Number of events 4 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
20.8%
5/24 • Number of events 5 • Baseline up until 4 weeks after the last dose of study drug (up to 2 years, 5 months).
One participant in Cohort 2 was randomized into the Placebo arm (Cohort 2: Placebo) and received the Placebo treatment in the study. However due to a data entry error, this participant was inadvertently analysed in the (Cohort 2: GDC-0853 200 mg BID) arm in the Safety-evaluable population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER