| Primary | Part 1 : Number Of Participants Experiencing Adverse Events | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (zanubrutinib in combination with obinutuzumab). An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A serious AE (SAE) was any untoward medical occurrence that, at any dose.
- resulted in death,
- was life threatening,
- required hospitalization or prolongation of existing hospitalization,
- resulted in disability/incapacity,
- was a congenital anomaly/birth defect.
| Part 1: Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab | Posted | | Count of Participants | | Participants | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. |
| | | Title | Denominators | Categories |
|---|
| Any TEAE | | | | SAE | | |
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| Primary | Part 1: Number Of Participants With Clinical Laboratory Abnormalities | Laboratory results are reported as participants with shifts towards (high directionality) or away (low directionality) from Grade 3 or Higher Toxicity. | The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab | Posted | | Count of Participants | | Participants | | Day -28 to -1 (predose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: 160 mg BID | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. | | OG001 | Part 1: 320 mg QD | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. |
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| Primary | Part 1: Number Of Deaths | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (zanubrutinib in combination with obinutuzumab). An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. An SAE was any untoward medical occurrence that, at any dose:
- resulted in death,
- was life threatening,
- required hospitalization or prolongation of existing hospitalization,
- resulted in disability/incapacity,
- was a congenital anomaly/birth defect.
| Part 1: The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab | Posted | | Count of Participants | | Participants | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. |
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| Primary | Part 1: Number Of Participants Experiencing Dose-limiting Toxicity (DLT) | Dose-limiting toxicities were defined as a toxicity or AE occurring during the DLT assessment period (first 29 days of treatment), which is not clearly attributable to a cause other than zanubrutinib and/or obinutuzumab (such as disease progression, underlying illness, concurrent illness or concomitant medication) and meets one of the following criteria:
- Grade 3 or 4 drug-related non-hematologic toxicity (excluding Grade 3 nausea, vomiting, hypertension, and asymptomatic laboratory abnormalities),
- Grade 4 drug-related hematologic toxicity persisting for >14 days,
- any grade toxicity, which in the judgment of the investigator or Sponsor, required removal of the participant from the study.
| Part 1:The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab | Posted | | Count of Participants | | Participants | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. |
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| Primary | Part 1 and Part 2: Number Of Participants Achieving A Best Response Of Partial Response | Partial response was defined as follows:
- ≥ 50% reduction of serum IgM from baseline,
- reduction in lymphadenopathy/splenomegaly (if present at baseline). For response assessments that occurred during cycles where a CT scan was not required, then results from prior scans (up to 12 weeks during the first 48 weeks and up to 24 weeks thereafter) could be carried forward in those participants with extramedullary disease at baseline.
| The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. The Safety Analysis Set was the primary analysis set for the efficacy and safety analyses. | Posted | | Count of Participants | | Participants | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 milligrams [mg] once daily [QD] and 160 mg twice daily [BID]) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1 and Part 2: Number Of Participants Achieving A Best Response Of Complete Response | Complete response was defined as follows:
- normal serum IgM values,
- disappearance of monoclonal protein by immunofixation,
- no histological evidence of bone marrow involvement,
- complete resolution of lymphadenopathy/splenomegaly (if present at baseline) For response assessments that occurred during cycles where a computed tomography (CT) scan was not required, then results from prior scans (up to 12 weeks during the first 48 weeks and up to 24 weeks thereafter) could be carried forward in those participants with extramedullary disease at baseline.
| The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. The Safety Analysis Set was the primary analysis set for the efficacy and safety analyses. | Posted | | Count of Participants | | Participants | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 milligrams [mg] once daily [QD] and 160 mg twice daily [BID]) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1 and Part 2: Progression-free Survival (PFS) | Progression-free survival was defined as time (in months) from the start of treatment with zanubrutinib or obinutuzumab to the first documented disease progression or death due to any cause, whichever occurred first. Results are reported as the median months for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and non-germinal center B-cell-like (GCB) diffuse large B-cell lymphoma (DLBCL). | The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. The Safety Analysis Set was the primary analysis set for the efficacy and safety analyses. | Posted | | Median | 95% Confidence Interval | Months | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 milligrams [mg] once daily [QD] and 160 mg twice daily [BID]) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1 and Part 2: Duration Of Response (DOR) | Duration of response for responders was defined as the time (in months) from the date of the earliest qualifying response to the date of progressive disease or death due to any cause (whichever occurred earlier). Duration of response was analyzed using the same methods as the analysis for PFS. Responses after initiating new anticancer therapy, roll over to the long-term extension (LTE) study, or the first occurrence of disease progression were not considered in the analysis. | The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. The Safety Analysis Set was the primary analysis set for the efficacy and safety analyses. | Posted | | Median | 95% Confidence Interval | Months | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 milligrams [mg] once daily [QD] and 160 mg twice daily [BID]) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1 and Part 2: Time To Response (TTR) | The TTR for responders was defined as time (in months) from the start of the study treatment to the date of the earliest qualifying response. The TTR was summarized using descriptive statistics. Responses after initiating new anticancer therapy, roll over to the LTE study, or the first occurrence of disease progression were not considered in the analysis of TTR. | The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. The Safety Analysis Set was the primary analysis set for the efficacy and safety analyses. | Posted | | Mean | Standard Deviation | Months | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 milligrams [mg] once daily [QD] and 160 mg twice daily [BID]) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1 and Part 2: Overall Survival (OS) | Overall survival was defined as the time (in months) from the date of the start of the study treatment to death due to any cause. Participants who were alive before final database lock or discontinuation of the study (discontinued study due to reasons other than death) were censored at their last known alive date on or before database lock. | The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. The Safety Analysis Set was the primary analysis set for the efficacy and safety analyses.. Only participants with post-baseline assessments and available data were included in the analysis. | Posted | | Median | 95% Confidence Interval | Months | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 milligrams [mg] once daily [QD] and 160 mg twice daily [BID]) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1 and Part 2: Hematologic Improvement In Participants With CLL | The number and percentage of participants with CLL with anemia (hemoglobin ≤110 grams/liter [g/L]), neutropenia (absolute neutrophil count ≤1.5 x 10^9/L), or thrombocytopenia (platelet count ≤100 x 10^9/L) at baseline were estimated. | The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. The Safety Analysis Set was the primary analysis set for the efficacy and safety analyses. Only participants with post-baseline assessments and available data were included in the analysis. | Posted | | Count of Participants | | Participants | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1: Area Under The Plasma Concentration-time Curve From Time 0 To The Time Of The Last Measurable Concentration (AUClast) Of Zanubrutinib | | The Pharmacokinetic Analysis Set included all participants who received at least the first administration of zanubrutinib and provided PK samples per protocol after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter*hour | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1: Area Under The Plasma Concentration-time Curve From Time 0 To Infinity Time (AUC) Of Zanubrutinib | | The PK Analysis Set included all participants who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter*hour | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1: Maximum Plasma Concentration (Cmax) Of Zanubrutinib | | The PK Analysis Set included all participants who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1: Time To Maximum Plasma Concentration (Tmax) Of Zanubrutinib | | The PK Analysis Set included all participants who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1: Terminal Elimination Half-life (t1/2) Of Zanubrutinib | | The PK Analysis Set included all participants who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1: Apparent Clearance (CL/F) Of Zanubrutinib | | The PK Analysis Set included all participants who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter/hour | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
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| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. |
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| Secondary | Part 1: Apparent Volume Of Distribution (Vz/F) Of Zanubrutinib | | The PK Analysis Set included all participants who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. |
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| Secondary | Part 1 and Part 2: Steady State AUClast Of Zanubrutinib | | The PK Analysis Set included all participants in Part and Part 2, who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1.Only participants with available samples were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter*hour | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1 and Part 2: Steady State Cmax of Zanubrutinib | | The PK Analysis Set included all participants Part and Part 2 who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 1 and Part 2: Steady State Tmax Of Zanubrutinib | | The PK Analysis Set included all participants Part and Part 2 who received at least the first administration of zanubrutinib and provided PK samples per protocol (without any significant protocol deviation affecting the PK blood sample) after the first administration of zanubrutinib on Cycle 1 Day 1. Only participants with available data were included in the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour | | Day 1 Cycle 1, Predose (within 3 hours), hours 1, 2, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Zanubrutinib and Obinutuzumab | Part 1: Two dose regimens of zanubrutinib (320 mg QD and 160 mg BID) in combination with obinutuzumab (dose regimen consistent with the US prescribing information) were evaluated. Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 2: Number Of Participants Experiencing Adverse Events | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (zanubrutinib in combination with obinutuzumab). An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. An SAE was any untoward medical occurrence that, at any dose,:
- resulted in death,
- was life threatening,
- required hospitalization or prolongation of existing hospitalization,
- resulted in disability/incapacity,
- was a congenital anomaly/birth defect.
| The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. | Posted | | Count of Participants | | Participants | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Zanubrutinib and Obinutuzumab | Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
| |
| Secondary | Part 2: Number Of Participants With Clinical Laboratory Abnormalities | Results are reported as participants with shifts towards (high directionality) or away (low directionality) from Grade 3 or Higher Toxicity. | The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab. Only participants with available data were included in the analysis. | Posted | | Count of Participants | | Participants | | Day -28 to -1 (predose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 2: 160 mg BID | Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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| Secondary | Part 2: Number Of Deaths | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (zanubrutinib in combination with obinutuzumab). An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. An SAE was any untoward medical occurrence that, at any dose,:
- resulted in death,
- is life threatening,
- required hospitalization or prolongation of existing hospitalization,
- resulted in disability/incapacity,
- was a congenital anomaly/birth defect.
| The Safety Analysis Set included all participants who received ≥ 1 dose of zanubrutinib and/or obinutuzumab | Posted | | Count of Participants | | Participants | | Day 1 (first dose) through 4 years and 8 months | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Zanubrutinib and Obinutuzumab | Part 2: The 2 dose regimens selected from Part 1 (zanubrutinib 320 mg QD and 160 mg BID in combination with obinutuzumab) were investigated in 5 expansion cohorts. |
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