Hodgkin Disease, Peripheral T Cell Lymphoma
Conditions
Keywords
Antibody-Drug Conjugate, Antibodies, Monoclonal, Hematologic Diseases, Hodgkin Disease, Antigens, CD30, Lymphoma, monomethylauristatin E, Drug Therapy, CD30-expression, PTCL, Seattle Genetics
Brief summary
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
Detailed description
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
Interventions
DRUGbrentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
DRUGbendamustine
70 mg/m\^2 by IV infusion on Days 1 and 2 of 3-week cycle
DRUGdacarbazine
375 mg/m\^2 every 3 weeks by IV infusion
DRUGnivolumab
3 mg/kg every 3 weeks by IV infusion
Sponsors
Bristol-Myers Squibb
Seagen Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Parts A, B, C, and D: 60 years of age or older * Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E) * Treatment-naive patients with CD30-expressing PTCL (Part F) * Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D) * Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by: * A CIRS score of 10 or greater * Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs) * Measurable disease of at least 1.5 cm as documented by radiographic technique * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
Exclusion criteria
* Symptomatic neurologic disease compromising IADLs or requiring medication * History of progressive multifocal leukoencephalopathy * Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin * Concurrent use of other investigational agents * Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug * History of another malignancy within 1 year before first dose of study drug (Parts E and F only) * Part D only: * Received any prior immune-oncology therapy * History of known or suspected autoimmune disease * Prior allogeneic stem cell transplant * History of cerebral vascular event within 6 months of first dose of study drug * Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology * Known history of pancreatitis * Parts D, E, and F only: * Known cerebral/meningeal disease related to the underlying malignancy * Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | Up to 81 months | Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). |
| ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D) | Up to 60 months | Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). |
| ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) | Up to 31 months | Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Complete Response | Up to 81 months | Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR. |
| Duration of Objective Response | Up to 81 months | Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR. |
| Progression-free Survival | Up to 83 months | Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR. |
| Disease Control Rate | Up to 81 months | Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR. |
| Number of Participants With Adverse Events | Up to 122 months | A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE. |
| B Symptom Resolution Rate | Up to 42 weeks | B symptom resolution rate per investigator was defined as the percentage of subjects with lymphoma-related B symptoms at baseline who achieved resolution of all B symptoms at any time during the treatment period. |
| Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Up to 30 months | — |
| Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only) | Up to 30 months | — |
| Overall Survival (Parts E and F Only) | Up to 44 months | Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause. |
| ORR According to Lugano Criteria Per BICR (Parts E and F) | Up to 31 months | Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. |
| Number of Participants With Laboratory Abnormalities | Up to 30 months | Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE. |
| Complete Response Rate | Up to 81 months | Complete response rate is defined as the percentage of patients with CR |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle. | 27 |
| Part B BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle. | 22 |
| Part C BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle. | 20 |
| Part D BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. | 21 |
| Part E BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. | 30 |
| Part F BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. | 7 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Change in performance status | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 13 | 9 | 12 | 4 | 10 | 5 |
| Overall Study | Lost to Follow-up | 3 | 3 | 0 | 2 | 1 | 0 |
| Overall Study | Patient withdrawal of consent | 4 | 2 | 4 | 3 | 2 | 0 |
| Overall Study | PI decision | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Received treatment past data cutoff of up to 16 doses of BV. AEs collected until end of study. | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Sponsor direction | 7 | 8 | 5 | 12 | 16 | 1 |
| Overall Study | Sponsor terminated enrollment into Part C | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part A | Part B | Part C | Part D | Part E | Part F | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 19 Participants | 19 Participants | 17 Participants | 29 Participants | 6 Participants | 115 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 12 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 | 9 Participants | 6 Participants | 4 Participants | 4 Participants | 5 Participants | 0 Participants | 28 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1 | 12 Participants | 9 Participants | 12 Participants | 16 Participants | 10 Participants | 4 Participants | 63 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2 | 5 Participants | 7 Participants | 4 Participants | 0 Participants | 10 Participants | 2 Participants | 28 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 3 | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 1 Participants | 7 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 4 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 5 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Missing | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 18 Participants | 20 Participants | 20 Participants | 28 Participants | 5 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 26 Participants | 19 Participants | 20 Participants | 19 Participants | 26 Participants | 7 Participants | 117 Participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 10 Participants | 6 Participants | 16 Participants | 2 Participants | 53 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 10 Participants | 15 Participants | 14 Participants | 5 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 13 / 27 | 9 / 22 | 12 / 20 | 4 / 21 | 10 / 30 | 5 / 7 |
| other Total, other adverse events | 27 / 27 | 22 / 22 | 20 / 20 | 21 / 21 | 27 / 30 | 7 / 7 |
| serious Total, serious adverse events | 5 / 27 | 4 / 22 | 13 / 20 | 4 / 21 | 14 / 30 | 4 / 7 |
Outcome results
Primary
Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Time frame: Up to 81 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A | Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | 93 Percentage of participants |
| Part B | Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | 95 Percentage of participants |
| Part C | Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | 85 Percentage of participants |
Primary
ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
Time frame: Up to 31 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A | ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) | 60 Percentage of participants |
| Part B | ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) | 43 Percentage of participants |
Primary
ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).
Time frame: Up to 60 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A | ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D) | 86 Percentage of participants |
Secondary
B Symptom Resolution Rate
B symptom resolution rate per investigator was defined as the percentage of subjects with lymphoma-related B symptoms at baseline who achieved resolution of all B symptoms at any time during the treatment period.
Time frame: Up to 42 weeks
Population: Subjects with any B symptom at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A | B Symptom Resolution Rate | 100 Percentage of participants |
| Part B | B Symptom Resolution Rate | 100 Percentage of participants |
| Part C | B Symptom Resolution Rate | 86 Percentage of participants |
| Part D | B Symptom Resolution Rate | 67 Percentage of participants |
| Part E | B Symptom Resolution Rate | 0 Percentage of participants |
| Part F | B Symptom Resolution Rate | 0 Percentage of participants |
Secondary
Complete Response Rate
Complete response rate is defined as the percentage of patients with CR
Time frame: Up to 81 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A | Complete Response Rate | 70 Percentage of participants |
| Part B | Complete Response Rate | 64 Percentage of participants |
| Part C | Complete Response Rate | 75 Percentage of participants |
| Part D | Complete Response Rate | 67 Percentage of participants |
| Part E | Complete Response Rate | 30 Percentage of participants |
| Part F | Complete Response Rate | 43 Percentage of participants |
Secondary
Disease Control Rate
Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR.
Time frame: Up to 81 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A | Disease Control Rate | 100 Percentage of participants |
| Part B | Disease Control Rate | 95 Percentage of participants |
| Part C | Disease Control Rate | 85 Percentage of participants |
| Part D | Disease Control Rate | 90 Percentage of participants |
| Part E | Disease Control Rate | 77 Percentage of participants |
| Part F | Disease Control Rate | 57 Percentage of participants |
Secondary
Duration of Complete Response
Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Time frame: Up to 81 months
Population: All subjects with CR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A | Duration of Complete Response | 7.4 Months |
| Part B | Duration of Complete Response | NA Months |
| Part C | Duration of Complete Response | NA Months |
| Part D | Duration of Complete Response | NA Months |
| Part E | Duration of Complete Response | NA Months |
| Part F | Duration of Complete Response | NA Months |
Secondary
Duration of Objective Response
Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Time frame: Up to 81 months
Population: All subjects with CR/PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A | Duration of Objective Response | 7.6 Months |
| Part B | Duration of Objective Response | 46.0 Months |
| Part C | Duration of Objective Response | NA Months |
| Part D | Duration of Objective Response | NA Months |
| Part E | Duration of Objective Response | 7.4 Months |
| Part F | Duration of Objective Response | NA Months |
Secondary
Number of Participants With Adverse Events
A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
Time frame: Up to 122 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A | Number of Participants With Adverse Events | Treatment-related TEAE leading to treatment discontinuation | 11 Participants |
| Part A | Number of Participants With Adverse Events | Treatment-related TEAE | 25 Participants |
| Part A | Number of Participants With Adverse Events | TEAE leading to death | 0 Participants |
| Part A | Number of Participants With Adverse Events | Treatment-related TEAE leading to death | 0 Participants |
| Part A | Number of Participants With Adverse Events | Any TEAE | 27 Participants |
| Part A | Number of Participants With Adverse Events | TEAE leading to treatment discontinuation | 11 Participants |
| Part A | Number of Participants With Adverse Events | Any treatment-emergent (TE) serious adverse event (SAE) | 5 Participants |
| Part A | Number of Participants With Adverse Events | Any grade 3 or higher TEAE | 17 Participants |
| Part A | Number of Participants With Adverse Events | Treatment-related grade 3 or higher TEAE | 13 Participants |
| Part A | Number of Participants With Adverse Events | Treatment-related TE SAE | 3 Participants |
| Part B | Number of Participants With Adverse Events | TEAE leading to death | 0 Participants |
| Part B | Number of Participants With Adverse Events | Treatment-related grade 3 or higher TEAE | 9 Participants |
| Part B | Number of Participants With Adverse Events | Any TEAE | 22 Participants |
| Part B | Number of Participants With Adverse Events | Treatment-related TEAE leading to death | 0 Participants |
| Part B | Number of Participants With Adverse Events | Treatment-related TEAE leading to treatment discontinuation | 9 Participants |
| Part B | Number of Participants With Adverse Events | Treatment-related TEAE | 22 Participants |
| Part B | Number of Participants With Adverse Events | TEAE leading to treatment discontinuation | 11 Participants |
| Part B | Number of Participants With Adverse Events | Treatment-related TE SAE | 3 Participants |
| Part B | Number of Participants With Adverse Events | Any grade 3 or higher TEAE | 10 Participants |
| Part B | Number of Participants With Adverse Events | Any treatment-emergent (TE) serious adverse event (SAE) | 4 Participants |
| Part C | Number of Participants With Adverse Events | Any treatment-emergent (TE) serious adverse event (SAE) | 13 Participants |
| Part C | Number of Participants With Adverse Events | Any TEAE | 20 Participants |
| Part C | Number of Participants With Adverse Events | Treatment-related TEAE | 19 Participants |
| Part C | Number of Participants With Adverse Events | Any grade 3 or higher TEAE | 18 Participants |
| Part C | Number of Participants With Adverse Events | Treatment-related grade 3 or higher TEAE | 16 Participants |
| Part C | Number of Participants With Adverse Events | Treatment-related TE SAE | 9 Participants |
| Part C | Number of Participants With Adverse Events | TEAE leading to treatment discontinuation | 12 Participants |
| Part C | Number of Participants With Adverse Events | Treatment-related TEAE leading to treatment discontinuation | 8 Participants |
| Part C | Number of Participants With Adverse Events | TEAE leading to death | 3 Participants |
| Part C | Number of Participants With Adverse Events | Treatment-related TEAE leading to death | 0 Participants |
| Part D | Number of Participants With Adverse Events | Any grade 3 or higher TEAE | 16 Participants |
| Part D | Number of Participants With Adverse Events | Any treatment-emergent (TE) serious adverse event (SAE) | 4 Participants |
| Part D | Number of Participants With Adverse Events | Treatment-related TE SAE | 0 Participants |
| Part D | Number of Participants With Adverse Events | Treatment-related TEAE | 18 Participants |
| Part D | Number of Participants With Adverse Events | TEAE leading to treatment discontinuation | 5 Participants |
| Part D | Number of Participants With Adverse Events | Any TEAE | 21 Participants |
| Part D | Number of Participants With Adverse Events | Treatment-related TEAE leading to death | 0 Participants |
| Part D | Number of Participants With Adverse Events | Treatment-related TEAE leading to treatment discontinuation | 2 Participants |
| Part D | Number of Participants With Adverse Events | TEAE leading to death | 1 Participants |
| Part D | Number of Participants With Adverse Events | Treatment-related grade 3 or higher TEAE | 12 Participants |
| Part E | Number of Participants With Adverse Events | TEAE leading to treatment discontinuation | 9 Participants |
| Part E | Number of Participants With Adverse Events | Any treatment-emergent (TE) serious adverse event (SAE) | 14 Participants |
| Part E | Number of Participants With Adverse Events | Any grade 3 or higher TEAE | 18 Participants |
| Part E | Number of Participants With Adverse Events | Treatment-related grade 3 or higher TEAE | 8 Participants |
| Part E | Number of Participants With Adverse Events | Treatment-related TEAE leading to treatment discontinuation | 5 Participants |
| Part E | Number of Participants With Adverse Events | Any TEAE | 30 Participants |
| Part E | Number of Participants With Adverse Events | Treatment-related TEAE leading to death | 1 Participants |
| Part E | Number of Participants With Adverse Events | TEAE leading to death | 4 Participants |
| Part E | Number of Participants With Adverse Events | Treatment-related TE SAE | 3 Participants |
| Part E | Number of Participants With Adverse Events | Treatment-related TEAE | 24 Participants |
| Part F | Number of Participants With Adverse Events | Any grade 3 or higher TEAE | 7 Participants |
| Part F | Number of Participants With Adverse Events | TEAE leading to treatment discontinuation | 3 Participants |
| Part F | Number of Participants With Adverse Events | Any TEAE | 7 Participants |
| Part F | Number of Participants With Adverse Events | Treatment-related TEAE | 6 Participants |
| Part F | Number of Participants With Adverse Events | Treatment-related grade 3 or higher TEAE | 4 Participants |
| Part F | Number of Participants With Adverse Events | TEAE leading to death | 2 Participants |
| Part F | Number of Participants With Adverse Events | Treatment-related TEAE leading to death | 1 Participants |
| Part F | Number of Participants With Adverse Events | Treatment-related TEAE leading to treatment discontinuation | 2 Participants |
| Part F | Number of Participants With Adverse Events | Treatment-related TE SAE | 1 Participants |
| Part F | Number of Participants With Adverse Events | Any treatment-emergent (TE) serious adverse event (SAE) | 4 Participants |
Secondary
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Time frame: Up to 30 months
Population: Subjects with a baseline and at least one post-baseline sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative | 23 Participants |
| Part A | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Negative post-baseline | 14 Participants |
| Part A | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Positive post-baseline | 9 Participants |
| Part A | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive | 3 Participants |
| Part A | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive - Negative post-baseline | 3 Participants |
| Part A | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive: Treatment-boosted post-baseline | 0 Participants |
| Part B | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Negative post-baseline | 12 Participants |
| Part B | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive | 2 Participants |
| Part B | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive: Treatment-boosted post-baseline | 0 Participants |
| Part B | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative | 20 Participants |
| Part B | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Positive post-baseline | 8 Participants |
| Part B | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive - Negative post-baseline | 2 Participants |
| Part C | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive: Treatment-boosted post-baseline | 0 Participants |
| Part C | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive - Negative post-baseline | 1 Participants |
| Part C | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive | 1 Participants |
| Part C | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Positive post-baseline | 11 Participants |
| Part C | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative | 16 Participants |
| Part C | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Negative post-baseline | 5 Participants |
| Part D | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive | 1 Participants |
| Part D | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Negative post-baseline | 12 Participants |
| Part D | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Positive post-baseline | 5 Participants |
| Part D | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive: Treatment-boosted post-baseline | 0 Participants |
| Part D | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive - Negative post-baseline | 1 Participants |
| Part D | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative | 17 Participants |
| Part E | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative | 24 Participants |
| Part E | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive - Negative post-baseline | 2 Participants |
| Part E | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Negative post-baseline | 17 Participants |
| Part E | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Positive post-baseline | 7 Participants |
| Part E | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive | 2 Participants |
| Part E | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive: Treatment-boosted post-baseline | 0 Participants |
| Part F | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive | 0 Participants |
| Part F | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Positive post-baseline | 0 Participants |
| Part F | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive - Negative post-baseline | 0 Participants |
| Part F | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Positive: Treatment-boosted post-baseline | 0 Participants |
| Part F | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative - Negative post-baseline | 6 Participants |
| Part F | Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) | Baseline Negative | 6 Participants |
Secondary
Number of Participants With Laboratory Abnormalities
Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
Time frame: Up to 30 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 3 | 1 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 1 | 1 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 3 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 1 | 3 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 2 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 1 | 14 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 1 | 9 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 2 | 1 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 2 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Hemoglobin High, Grade 1 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 2 | 1 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Urate High, Grade 4 | 3 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Urate High, Grade 3 | 5 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 1 | 10 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 2 | 5 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Urate High, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 3 | 1 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Urate High, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 1 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 2 | 3 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 1 | 20 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 1 | 3 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 3 | 1 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 2 | 4 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 3 | 6 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 1 | 1 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 1 | 11 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 2 | 3 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 3 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 1 | 15 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 1 | 4 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 2 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 3 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 1 | 8 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 1 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 2 | 4 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 2 | 10 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 3 | 1 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 3 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 1 | 8 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 2 | 3 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 2 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 3 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 3 | 2 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 1 | 6 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 4 | 0 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 1 | 10 Participants |
| Part A | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 2 | 3 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 1 | 5 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 1 | 6 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Urate High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 2 | 6 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 1 | 14 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 3 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Urate High, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 3 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 1 | 3 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 2 | 3 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 1 | 2 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 3 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 1 | 9 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 1 | 2 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 2 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 3 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 2 | 6 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 2 | 7 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 3 | 2 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 1 | 7 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 3 | 2 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 4 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 2 | 4 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 1 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 1 | 6 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 3 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 2 | 5 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 1 | 8 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 1 | 8 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 4 | 2 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 2 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 1 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 2 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 2 | 3 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 1 | 2 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 1 | 13 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Hemoglobin High, Grade 1 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 2 | 1 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 2 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 1 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Urate High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 1 | 10 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 3 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 4 | 0 Participants |
| Part B | Number of Participants With Laboratory Abnormalities | Urate High, Grade 3 | 7 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 1 | 10 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 1 | 12 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Urate High, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 1 | 8 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 2 | 6 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 1 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Urate High, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 4 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 3 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 1 | 5 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 2 | 5 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 2 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 1 | 5 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 1 | 2 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 2 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 1 | 2 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 2 | 5 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 3 | 5 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 2 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Urate High, Grade 3 | 4 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 1 | 12 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 4 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 1 | 6 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 1 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 3 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 1 | 9 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 1 | 4 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 4 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Hemoglobin High, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 2 | 2 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 3 | 4 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 2 | 5 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 3 | 3 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 2 | 3 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 3 | 3 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 2 | 1 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Urate High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 2 | 2 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 2 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 3 | 3 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 2 | 2 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 3 | 6 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 1 | 2 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 4 | 9 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 4 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 1 | 4 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 2 | 3 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 1 | 8 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 1 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 3 | 0 Participants |
| Part C | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 2 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 3 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 1 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 1 | 12 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 2 | 5 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 3 | 4 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 1 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Hemoglobin High, Grade 1 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 1 | 9 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 2 | 5 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 3 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 1 | 3 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 2 | 3 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 3 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 1 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 2 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 1 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 2 | 6 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 3 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 4 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 1 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 2 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 3 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 4 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 1 | 3 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 2 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 4 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 1 | 16 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 3 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 1 | 9 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 2 | 6 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 1 | 4 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 2 | 4 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 3 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 1 | 5 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 2 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 3 | 3 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 1 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 2 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 1 | 16 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 3 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 4 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 1 | 7 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 2 | 6 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 3 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 1 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 2 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 1 | 8 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 3 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 1 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 2 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 3 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 1 | 9 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 3 | 3 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 1 | 3 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 1 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 2 | 4 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 3 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Urate High, Grade 1 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Urate High, Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Urate High, Grade 3 | 9 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Urate High, Grade 4 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 2 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 1 | 1 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 2 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 3 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 4 | 0 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 1 | 12 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 2 | 2 Participants |
| Part D | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 3 | 2 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 4 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 2 | 8 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 3 | 2 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 3 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 1 | 2 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 3 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 2 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 1 | 6 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 1 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 1 | 5 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 2 | 2 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Urate High, Grade 1 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 2 | 6 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 1 | 6 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 1 | 13 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 1 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Urate High, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 1 | 7 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Urate High, Grade 3 | 4 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 2 | 4 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 1 | 7 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 2 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Urate High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Hemoglobin High, Grade 1 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 3 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 2 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 2 | 7 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 1 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 1 | 11 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 1 | 7 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 1 | 9 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 1 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 1 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 2 | 4 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 1 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 4 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 3 | 2 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 1 | 5 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 1 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 2 | 2 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 4 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 1 | 18 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 1 | 1 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 1 | 12 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 2 | 11 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 3 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 1 | 2 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 1 | 2 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 2 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 1 | 0 Participants |
| Part E | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 1 | 2 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 1 | 3 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 1 | 3 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 1 | 2 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 1 | 2 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 3 | 2 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 2 | 1 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 3 | 2 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 2 | 2 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 2 | 2 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 3 | 1 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 2 | 1 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lymphocytes High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 1 | 3 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glomerular Filtration Rate, Estimated Low, Grade 1 | 1 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 1 | 1 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 2 | 1 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 1 | 4 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Total Bilirubin High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 2 | 1 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Urate High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 1 | 4 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 2 | 2 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Urate High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Urate High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Hemoglobin High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Urate High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Hemoglobin High. Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glucose Low, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 1 | 3 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Lipase High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Glucose High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Amylase High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Phosphate Low, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 4 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 1 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 3 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 2 | 0 Participants |
| Part F | Number of Participants With Laboratory Abnormalities | Potassium High, Grade 2 | 0 Participants |
Secondary
Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)
Time frame: Up to 30 months
Population: Subject with baseline negative anti-drug antibody (ADA)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A | Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only) | Cycle 1 (Pre-dose nivolumab) | 0 Participants |
| Part A | Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only) | First Positive Cycle (pre-dose) - Cycle 2 | 4 Participants |
| Part A | Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only) | First Positive Cycle (pre-dose) - Cycle 8 | 1 Participants |
| Part A | Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only) | Any positive post-baseline | 5 Participants |
Secondary
ORR According to Lugano Criteria Per BICR (Parts E and F)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment.
Time frame: Up to 31 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A | ORR According to Lugano Criteria Per BICR (Parts E and F) | 67 Percentage of participants |
| Part B | ORR According to Lugano Criteria Per BICR (Parts E and F) | 43 Percentage of participants |
Secondary
Overall Survival (Parts E and F Only)
Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause.
Time frame: Up to 44 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A | Overall Survival (Parts E and F Only) | 31.8 Months |
| Part B | Overall Survival (Parts E and F Only) | 12.6 Months |
Secondary
Progression-free Survival
Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Time frame: Up to 83 months
Population: All subjects who received at least one dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A | Progression-free Survival | 8.6 Months |
| Part B | Progression-free Survival | 47.2 Months |
| Part C | Progression-free Survival | 32.5 Months |
| Part D | Progression-free Survival | NA Months |
| Part E | Progression-free Survival | 8.7 Months |
| Part F | Progression-free Survival | 10.5 Months |