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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN27200385 | Other Identifier | ISRCTN (United Kingdom) |
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The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDC-8264, 35 mg | Experimental | Participants will receive oral GDC-8264, 35 milligrams (mg), once daily (QD) for 28 days. |
|
| GDC-8264, 75 mg | Experimental | Participants will receive oral GDC-8264, 75 mg, PO, QD for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-8264 | Drug | GDC-8264 tablets will be administered as per the schedule specified in the respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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. | From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months) |
| Plasma Concentration of GDC-8264 | Plasma concentration of GDC-8264 at specified timepoints was determined. | Predose, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose on Days 1 and 4; Predose on Days 8, 15, 22, 29 |
| Maximum Plasma Concentration (Cmax) of GDC-8264 | 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. | Day 1 and SS visit (any time between Day 4 to Day 28) |
| Time to Reach Maximum Plasma Concentration (Tmax) of GDC-8264 | 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. | Day 1 and SS visit (any time between Day 4 to Day 28) |
| Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of GDC-8264 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) on Day 29 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Massachusetts General Hospital |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | GDC-8264 75 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2023 |
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| Day 1 and SS visit (any time between Day 4 to Day 28) |
| Terminal Half-life (T1/2) of GDC-8264 | 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. | Day 1 and SS visit (any time between Day 4 to Day 28) |
| Apparent Clearance (CL/F) of GDC-8264 | 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. | Day 1 and SS visit (any time between Day 4 to Day 28) |
| Apparent Volume of Distribution (Vz/F) of GDC-8264 | 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. | Day 1 and SS visit (any time between Day 4 to Day 28) |
| Up to Day 29 |
| Duration of Response (DOR) | 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. | From Day 29 up to end of study (up to 9 months) |
| Percentage of Participants With aGVHD Flares by Day 56 | 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. | Baseline up to Day 56 |
| Percentage of Participants With Non-relapse Mortality (NRM) by Day 180 | 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. | Baseline up to Day 180 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period.
| COMPLETED |
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| NOT COMPLETED |
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Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received.
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| ID | Title | Description |
|---|---|---|
| BG000 | GDC-8264 35 mg | Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | 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. | Safety population included participants who received at least one dose of GDC-8264, with participants grouped according to treatment received. | Posted | Count of Participants | Participants | From signing informed consent form until 28 days after the final dose of GDC-8264 (up to 9 months) |
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| Primary | Plasma Concentration of GDC-8264 | Plasma concentration of GDC-8264 at specified timepoints was determined. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/millilitres (ng/mL) | Predose, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose on Days 1 and 4; Predose on Days 8, 15, 22, 29 |
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| Primary | Maximum Plasma Concentration (Cmax) of GDC-8264 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 and SS visit (any time between Day 4 to Day 28) |
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| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of GDC-8264 | 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. | 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. | Posted | Median | Full Range | hours | Day 1 and SS visit (any time between Day 4 to Day 28) |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of GDC-8264 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/millilitres (ng*hr/mL) | Day 1 and SS visit (any time between Day 4 to Day 28) |
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| Primary | Terminal Half-life (T1/2) of GDC-8264 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 1 and SS visit (any time between Day 4 to Day 28) |
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| Primary | Apparent Clearance (CL/F) of GDC-8264 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | millilitres/hours (mL/hr) | Day 1 and SS visit (any time between Day 4 to Day 28) |
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| Primary | Apparent Volume of Distribution (Vz/F) of GDC-8264 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | millilitres (mL) | Day 1 and SS visit (any time between Day 4 to Day 28) |
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| Secondary | Overall Response Rate (ORR) on Day 29 | 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. | 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. | Posted | Number | percentage of participants | Up to Day 29 |
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| Secondary | Duration of Response (DOR) | 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. | 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. | Posted | Median | 95% Confidence Interval | days | From Day 29 up to end of study (up to 9 months) |
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| Secondary | Percentage of Participants With aGVHD Flares by Day 56 | 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. | 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. | Posted | Number | percentage of participants | Baseline up to Day 56 |
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| Secondary | Percentage of Participants With Non-relapse Mortality (NRM) by Day 180 | 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. | 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. | Posted | Number | percentage of participants | Baseline up to Day 180 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GDC-8264 35mg | Participants received GDC-8264, 35 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period. | 3 | 4 | 4 | 4 | 4 | 4 |
| EG001 | GDC-8264 75mg | Participants received GDC-8264, 75 mg tablets, orally, QD in combination with standard-of-care corticosteroid treatment during the 28 day treatment period. | 2 | 3 | 3 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Viraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Anal incontinence | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Generalised oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypothermia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukoplakia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech Inc | 800 821-8590 | genentech@druginfo.com |
| Apr 7, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2023 | Apr 7, 2025 | ICF_001.pdf |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
|
|
|