Trial Outcomes & Findings for A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD) (NCT NCT05673876)
NCT ID: NCT05673876
Last Updated: 2025-05-28
Results Overview
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Results posted on
2025-05-28
Participant Flow
A total of 7 participants took part in the study across 4 investigative sites in the United States from 06 April 2023 to 15 January 2024.
Participants with acute graft-versus-host disease (aGVHD) were randomized in 1:1 ratio to receive GDC-8264, 35 milligrams (mg) or GDC-8264, 75 mg.
Participant milestones
| Measure |
GDC-8264 35 mg
Participants received GDC-8264, 35 mg tablets, orally, once daily (QD) in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
GDC-8264 35 mg
Participants received GDC-8264, 35 mg tablets, orally, once daily (QD) in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)
Baseline characteristics by cohort
| Measure |
GDC-8264 35 mg
n=4 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=3 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)Population: Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
GDC-8264 35 mg
n=4 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=3 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Predose, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose on Days 1 and 4; Predose on Days 8, 15, 22, 29Population: Pharmacokinetic (PK) population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Plasma concentration of GDC-8264 at specified timepoints was determined.
Outcome measures
| Measure |
GDC-8264 35 mg
n=3 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=3 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Plasma Concentration of GDC-8264
Predose on Day 29
|
61.5 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 297.2
|
1.51 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation NA
Values were LTR for one participant. Since only one participant was evaluable, the geometric coefficient of variation could not be estimated.
|
|
Plasma Concentration of GDC-8264
24 hours Postdose on Day 1
|
12.2 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 5241.5
|
144 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 116.0
|
|
Plasma Concentration of GDC-8264
Predose on Day 4
|
58.9 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 167.3
|
167 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 78.1
|
|
Plasma Concentration of GDC-8264
1.5 hours Postdose on Day 4
|
400 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 27.2
|
195 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 158.2
|
|
Plasma Concentration of GDC-8264
2 hours Postdose on Day 4
|
529 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 31.8
|
218 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 181.5
|
|
Plasma Concentration of GDC-8264
3 hours Postdose on Day 4
|
433 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 19.2
|
318 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 223.3
|
|
Plasma Concentration of GDC-8264
12 hours Postdose on Day 1
|
24.0 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 28439.7
|
361 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 106.5
|
|
Plasma Concentration of GDC-8264
Predose on Day 1
|
NA nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation NA
The geometric mean and geometric coefficient of variation was not estimable as the samples were below the limit of quantification (BLQ).
|
NA nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation NA
The geometric mean and geometric coefficient of variation was not estimable as the samples were BLQ.
|
|
Plasma Concentration of GDC-8264
1.5 hours Postdose on Day 1
|
28.3 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 141.5
|
698 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 17.0
|
|
Plasma Concentration of GDC-8264
2 hours Postdose on Day 1
|
151 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
835 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 10.3
|
|
Plasma Concentration of GDC-8264
3 hours Postdose on Day 1
|
89.7 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 321.6
|
858 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 57.2
|
|
Plasma Concentration of GDC-8264
4 hours Postdose on Day 1
|
123 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 141.1
|
781 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 33.8
|
|
Plasma Concentration of GDC-8264
6 hours Postdose on Day 1
|
227 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
700 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 52.5
|
|
Plasma Concentration of GDC-8264
4 hours Postdose on Day 4
|
374 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 8.8
|
393 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 175.7
|
|
Plasma Concentration of GDC-8264
6 hours Postdose on Day 4
|
274 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 6.7
|
539 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 127.1
|
|
Plasma Concentration of GDC-8264
12 hours Postdose on Day 4
|
129 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 43.1
|
373 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 82.6
|
|
Plasma Concentration of GDC-8264
24 hours Postdose on Day 4
|
43.2 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 143.2
|
140 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 79.9
|
|
Plasma Concentration of GDC-8264
Predose on Day 8
|
39.5 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 138.0
|
266 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 70.1
|
|
Plasma Concentration of GDC-8264
Predose on Day 15
|
6.47 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation NA
Values were less than reportable (LTR) for one participant. Since only one participant was evaluable, the geometric coefficient of variation could not be estimated.
|
294 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 54.6
|
|
Plasma Concentration of GDC-8264
Predose on Day 22
|
6.50 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation NA
Values were LTR for one participant. Since only one participant was evaluable, the geometric coefficient of variation could not be estimated.
|
276 nanograms/millilitres (ng/mL)
Geometric Coefficient of Variation 180.1
|
PRIMARY outcome
Timeframe: Day 1 and SS visit (any time between Day 4 to Day 28)Population: PK population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Steady-state (SS) PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Outcome measures
| Measure |
GDC-8264 35 mg
n=3 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=2 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of GDC-8264
SS PK Day
|
541.48 ng/mL
Geometric Coefficient of Variation 31.1
|
1480.00 ng/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
|
Maximum Plasma Concentration (Cmax) of GDC-8264
Day 1
|
270.00 ng/mL
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
991.21 ng/mL
Geometric Coefficient of Variation 33.7
|
PRIMARY outcome
Timeframe: Day 1 and SS visit (any time between Day 4 to Day 28)Population: PK population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Outcome measures
| Measure |
GDC-8264 35 mg
n=3 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=2 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of GDC-8264
SS PK Day
|
2.17 hours
Interval 1.5 to 3.1
|
3.2 hours
Interval 3.2 to 3.2
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of GDC-8264
Day 1
|
3.4 hours
Interval 3.4 to 3.4
|
2.30 hours
Interval 1.6 to 3.0
|
PRIMARY outcome
Timeframe: Day 1 and SS visit (any time between Day 4 to Day 28)Population: PK population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Outcome measures
| Measure |
GDC-8264 35 mg
n=3 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=2 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of GDC-8264
Day 1
|
3250.37 nanograms*hours/millilitres (ng*hr/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
10528.86 nanograms*hours/millilitres (ng*hr/mL)
Geometric Coefficient of Variation 57.8
|
|
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of GDC-8264
SS PK Day
|
4534.44 nanograms*hours/millilitres (ng*hr/mL)
Geometric Coefficient of Variation 24.4
|
19405.83 nanograms*hours/millilitres (ng*hr/mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
PRIMARY outcome
Timeframe: Day 1 and SS visit (any time between Day 4 to Day 28)Population: PK population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Outcome measures
| Measure |
GDC-8264 35 mg
n=3 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=2 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Terminal Half-life (T1/2) of GDC-8264
Day 1
|
7.03 hours
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
7.82 hours
Geometric Coefficient of Variation 27.2
|
|
Terminal Half-life (T1/2) of GDC-8264
SS PK Day
|
6.84 hours
Geometric Coefficient of Variation 50.2
|
8.70 hours
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
PRIMARY outcome
Timeframe: Day 1 and SS visit (any time between Day 4 to Day 28)Population: PK population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Outcome measures
| Measure |
GDC-8264 35 mg
n=3 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=2 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Apparent Clearance (CL/F) of GDC-8264
Day 1
|
9608.61 millilitres/hours (mL/hr)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
6131.74 millilitres/hours (mL/hr)
Geometric Coefficient of Variation 69.5
|
|
Apparent Clearance (CL/F) of GDC-8264
SS PK Day
|
6871.73 millilitres/hours (mL/hr)
Geometric Coefficient of Variation 32.5
|
3216.19 millilitres/hours (mL/hr)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
PRIMARY outcome
Timeframe: Day 1 and SS visit (any time between Day 4 to Day 28)Population: PK population included participants who received at least one dose of GDC-8264 and had at least one evaluable post-dose PK concentration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
SS PK visit was Day 4 if the participant was hospitalized or Day 8 if the participant was an outpatient. If the SS PK visit samples could not be obtained on Day 4/8, the SS PK visit may have occurred on any dosing day between Day 4 and 28.
Outcome measures
| Measure |
GDC-8264 35 mg
n=3 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=2 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of GDC-8264
Day 1
|
97480.88 millilitres (mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
69212.58 millilitres (mL)
Geometric Coefficient of Variation 37.3
|
|
Apparent Volume of Distribution (Vz/F) of GDC-8264
SS PK Day
|
67784.28 millilitres (mL)
Geometric Coefficient of Variation 21.0
|
40355.80 millilitres (mL)
Geometric Coefficient of Variation NA
Since only 1 participant was analyzed, geometric coefficient of variation could not be calculated.
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Modified intent to treat (mITT) included all enrolled participants who received at least one dose of GDC-8264 and did not miss more than four doses of the GDC-8264 within the first 14 days of the treatment period due to participant noncompliance, voluntary withdrawal, or reasons other than safety or (lack of) efficacy. Percentages have been rounded off.
ORR=percentage of participants with complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by investigator. CR=all target organs evaluated as Mount Sinai Acute GVHD International Consortium (MAGIC) aGVHD Stage 0 \[Skin- no GVHD rash; Liver - bilirubin \<2 milligrams/decilitres (mg/dL); Upper gastrointestinal (GI) tract - no intermittent nausea, vomiting/anorexia; Lower GI tract - stool output: \< 500 mL/day or \<3 episodes/day (adults), \<10 mL/kilograms (kg)/day or \<4 episodes/day\]. VGPR=resolution of signs \& symptoms i.e. no rash/residual erythematous rash involving \< 25% of body surface, without (w/o) bullae; bilirubin \<2 mg/dL or \<25% of baseline at screening; toleration of food/enteral feeding; predominantly formed stools; no overt GI bleeding/abdominal cramping; no more than occasional nausea/vomiting. PR=improvement in one/more target organs (skin, liver, upper GI tract, lower GI tract) involved with aGVHD symptoms w/o worsening in others.
Outcome measures
| Measure |
GDC-8264 35 mg
n=2 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=3 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Overall Response Rate (ORR) on Day 29
|
100 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 29 up to end of study (up to 9 months)Population: mITT included all enrolled participants who received at least one dose of GDC-8264 and did not miss more than four doses of the GDC-8264 within the first 14 days of the treatment period due to participant noncompliance, voluntary withdrawal, or reasons other than safety or (lack of) efficacy. Overall number analyzed is the number of participants with OR i.e. responders.
DOR was defined astime from response (CR, VGPR or PR) on Day 29 to aGVHD progression from nadir in any organ, new systemic therapy for aGVHD, or death from any cause (whichever occurs first), as determined by the investigator. CR=all target organs evaluated as MAGIC aGVHD Stage 0 \[Skin- no GVHD rash; Liver - bilirubin \<2 mg/dL; Upper GI tract - no intermittent nausea, vomiting/anorexia; Lower GI tract - stool output: \< 500 mL/day or \<3 episodes/day (adults), \<10 mL/kg/day or \<4 episodes/day\]. VGPR=resolution of signs \& symptoms i.e. no rash or residual erythematous rash involving \< 25% of body surface, without bullae; bilirubin \<2 mg/dL or \<25% of baseline at screening; toleration of food/enteral feeding; predominantly formed stools; no overt GI bleeding or abdominal cramping; no more than occasional nausea or vomiting. PR=improvement in one or more target organs (skin, liver, upper GI tract, lower GI tract) involved with aGVHD symptoms without worsening in others.
Outcome measures
| Measure |
GDC-8264 35 mg
n=2 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=2 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Duration of Response (DOR)
|
1.00 days
Interval 1.0 to 1.0
|
4.00 days
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 56Population: mITT included all enrolled participants who received at least one dose of GDC-8264 and did not miss more than four doses of the GDC-8264 within the first 14 days of the treatment period due to participant noncompliance, voluntary withdrawal, or reasons other than safety or (lack of) efficacy. Percentages have been rounded off.
aGVHD flare was defined as an increase in aGVHD target organ stage by at least one stage for at least 3 days that requires either addition of a new line of systemic treatment or increase in corticosteroid dose \> 0.25 mg/kg/day.
Outcome measures
| Measure |
GDC-8264 35 mg
n=2 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=3 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Percentage of Participants With aGVHD Flares by Day 56
|
50 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 180Population: mITT included all enrolled participants who received at least one dose of GDC-8264 and did not miss more than four doses of the GDC-8264 within the first 14 days of the treatment period due to participant noncompliance, voluntary withdrawal, or reasons other than safety or (lack of) efficacy. Percentages have been rounded off.
NRM was defined as any death that occurred after onset of aGVHD that was not attributable to relapse of the underlying primary disease was considered a non-relapse death.
Outcome measures
| Measure |
GDC-8264 35 mg
n=2 Participants
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75 mg
n=3 Participants
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Percentage of Participants With Non-relapse Mortality (NRM) by Day 180
|
0 percentage of participants
|
66.7 percentage of participants
|
Adverse Events
GDC-8264 35mg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
GDC-8264 75mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
GDC-8264 35mg
n=4 participants at risk
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75mg
n=3 participants at risk
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Death
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Viraemia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
Other adverse events
| Measure |
GDC-8264 35mg
n=4 participants at risk
Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
GDC-8264 75mg
n=3 participants at risk
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Eye disorders
Vision blurred
|
50.0%
2/4 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
100.0%
3/3 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Generalised oedema
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Hypothermia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Oedema peripheral
|
50.0%
2/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Injury, poisoning and procedural complications
Injury
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
Blood creatinine increased
|
75.0%
3/4 • Number of events 4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Investigations
White blood cell count decreased
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
2/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
2/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
2/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 2 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.00%
0/4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
0.00%
0/3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • Number of events 4 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
66.7%
2/3 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
|
Vascular disorders
Hypotension
|
75.0%
3/4 • Number of events 3 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
33.3%
1/3 • Number of events 1 • From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months)
Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
|
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