Trial Outcomes & Findings for Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma (NCT NCT00868608)

NCT ID: NCT00868608

Last Updated: 2017-10-31

Results Overview

CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to \[≤\]1.5 cm in their greatest transverse diameter \[GTD\] for nodes more than \[\>\]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as \>50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to \[≥\]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 81 participants
• Primary outcome timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
• Results posted on: 2017-10-31

Participant Flow

Participant milestones

Measure	Inotuzumab Ozogamicin - NHL Type (Follicular) Participants who have been previously diagnosed with CD22-positive, indolent Non-Hodgkin's Lymphoma (NHL) defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 percent \[%\] of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Marginal Zone) Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic) Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Overall Study STARTED	72	4	5
Overall Study COMPLETED	49	1	0
Overall Study NOT COMPLETED	23	3	5

Reasons for withdrawal

Measure	Inotuzumab Ozogamicin - NHL Type (Follicular) Participants who have been previously diagnosed with CD22-positive, indolent Non-Hodgkin's Lymphoma (NHL) defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 percent \[%\] of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Marginal Zone) Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic) Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Overall Study Withdrawal by Subject	3	1	0
Overall Study Lost to Follow-up	3	0	1
Overall Study Death	16	2	4
Overall Study Other - Unspecified	1	0	0

Baseline Characteristics

Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

Baseline characteristics by cohort

Measure	Inotuzumab Ozogamicin - NHL Type (Follicular) n=72 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Marginal Zone) n=4 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic) n=5 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Total n=81 Participants Total of all reporting groups
Age, Continuous	60.5 Years STANDARD_DEVIATION 10.2 • n=5 Participants	70.8 Years STANDARD_DEVIATION 13.5 • n=7 Participants	65.2 Years STANDARD_DEVIATION 10.0 • n=5 Participants	61.3 Years STANDARD_DEVIATION 10.5 • n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	44 Participants n=4 Participants

PRIMARY outcome

Timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: Intent to treat (ITT) population: all participants who were enrolled into the study.

CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 cm in their greatest transverse diameter [GTD] for nodes more than [>]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to [≥]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=81 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL

66.7 Percentage of Participants Interval 55.32 to 76.76

SECONDARY outcome

Timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: ITT population (participants with NHL type defined as follicular).

CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or greatest transverse diameter (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=72 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL

70.8 Percentage of Participants Interval 58.93 to 80.95

SECONDARY outcome

Timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: ITT population.

CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=81 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL

30.9 Percentage of Participants Interval 21.07 to 42.11

SECONDARY outcome

Timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: ITT population (participants with NHL type defined as follicular).

CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=72 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL

34.7 Percentage of Participants Interval 23.88 to 46.86

SECONDARY outcome

Timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: Participants with Indolent NHL who responded.

Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=54 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Duration of Response in Participants With Indolent NHL

24.8 Months Interval 10.9 to Upper confidence interval (CI) could not be estimated by the SAS LIFETEST procedure due to limited number of events observed. SAS LIFETEST is a statistical procedure used to make inferences about a broader population based on the sample data.

SECONDARY outcome

Timeframe: 6, 12 and 24 months

Population: Participants with Indolent NHL who responded.

Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=54 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL 6 Month Probability of Maintaining a Response	0.82 Probability Interval 0.68 to 0.9
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL 12 Month Probability of Maintaining a Response	0.65 Probability Interval 0.5 to 0.77
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL 24 Month Probability of Maintaining a Response	0.53 Probability Interval 0.38 to 0.66

SECONDARY outcome

Timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: Participants with Follicular NHL who responded.

Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=51 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Duration of Response in Participants With Follicular NHL

24.8 Months Interval 12.9 to Upper CI could not be estimated by the SAS LIFETEST procedure due to limited number of events observed. SAS LIFETEST is a statistical procedure used to make inferences about a broader population based on the sample data.

SECONDARY outcome

Timeframe: 6, 12 and 24 months

Population: Participants with Follicular NHL who responded.

Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=51 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL 6 Month Probability of Maintaining a Response	0.85 Probability Interval 0.71 to 0.92
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL 12 Month Probability of Maintaining a Response	0.67 Probability Interval 0.51 to 0.79
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL 24 Month Probability of Maintaining a Response	0.57 Probability Interval 0.4 to 0.7

SECONDARY outcome

Timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: ITT population.

Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=81 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL

12.7 Months Interval 8.9 to 26.9

SECONDARY outcome

Timeframe: 6, 12 and 24 months

Population: ITT population.

Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=81 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL 6 Months	65.1 Percent Probability Interval 53.3 to 74.6
Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL 12 Months	52.0 Percent Probability Interval 40.0 to 62.7
Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL 24 Months	41.3 Percent Probability Interval 29.8 to 52.5

SECONDARY outcome

Timeframe: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: ITT population (participants with NHL type defined as follicular).

Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=72 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL

14.7 Months Interval 11.0 to Upper CI could not be estimated by the SAS LIFETEST procedure due to limited number of events observed. SAS LIFETEST is a statistical procedure used to make inferences about a broader population based on the sample data.

SECONDARY outcome

Timeframe: 6, 12 and 24 months

Population: ITT population (participants with NHL type defined as follicular).

Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=72 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL 6 Months	69.3 Percenr probability Interval 56.8 to 78.8
Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL 12 Months	56.3 Percenr probability Interval 43.4 to 67.3
Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL 24 Months	46.1 Percenr probability Interval 33.5 to 57.8

SECONDARY outcome

Timeframe: Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: ITT population.

Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=81 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL

NA Months Interval 26.6 to Median and upper CI could not be estimated by the SAS LIFETEST procedure due to limited number of events observed. SAS LIFETEST is a statistical procedure used to make inferences about a broader population based on the sample data.

SECONDARY outcome

Timeframe: 6, 12 and 24 months

Population: ITT population.

Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=81 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL 24 Months	0.73 Probability Interval 0.61 to 0.81
Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL 6 Months	0.89 Probability Interval 0.79 to 0.94
Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL 12 Months	0.80 Probability Interval 0.69 to 0.87

SECONDARY outcome

Timeframe: Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Population: ITT population (participants with NHL type defined as follicular).

Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.

Outcome measures

Measure

Inotuzumab Ozogamicin - Total (All NHL Types) n=72 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.

Kaplan-Meier Estimate of the OS in Participants With Follicular NHL

NA Months Median and lower and upper CIs could not be estimated by the SAS LIFETEST procedure due to limited number of events observed. SAS LIFETEST is a statistical procedure used to make inferences about a broader population based on the sample data.

SECONDARY outcome

Timeframe: 6, 12 and 24 months

Population: ITT population (participants with NHL type defined as follicular).

Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=72 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL 6 Months	0.91 Probability Interval 0.82 to 0.96
Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL 12 Months	0.83 Probability Interval 0.72 to 0.9
Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL 24 Months	0.78 Probability Interval 0.67 to 0.86

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit

Population: There were 80 participants in the analysis dataset, but time-matched PK-ECG data only existed for 73 participants (35 female).

Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart. ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis. A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS). QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure. Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=80 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax) Cycle 1	3.51 Milliseconds (msec) Interval 1.85 to 5.4
Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax) Cycle 2	5.00 Milliseconds (msec) Interval 3.19 to 6.8
Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax) Cycle 3	6.41 Milliseconds (msec) Interval 4.01 to 8.64
Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax) Cycle 4	7.83 Milliseconds (msec) Interval 4.83 to 10.8

SECONDARY outcome

Timeframe: Protocol reporting period: from informed consent to at least 28 days after the last dose.

Population: Safety Population - includes all participants who received at least 1 dose of study medication. This population only excluded participants who never received any study medication.

Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=81 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) % participants with a TEAE	96.3 Percentage of Participants
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) % participants with serious TEAE	18.5 Percentage of Participants
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) % participants with Grade 3 or higher TEAE	77.8 Percentage of Participants
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) % participants for study drug discontinuation	58.0 Percentage of Participants
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) % participants with dose reduction due to TEAE	33.3 Percentage of Participants
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) % participants for study drug stopped temporarily	48.1 Percentage of Participants

SECONDARY outcome

Timeframe: Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.

Population: Safety Population

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec. Participants are reported only once under the maximum QTcF interval observed at any of the time-points. Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.

Outcome measures

Measure	Inotuzumab Ozogamicin - Total (All NHL Types) n=81 Participants Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) % participants with QTcF ≤450 ([msec)	83.1 Percentage of Participants
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) % participants with QTcF >450 to ≤480 (msec)	14.3 Percentage of Participants
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) % participants with QTcF >480 to ≤500 (msec)	2.6 Percentage of Participants
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) % participants with QTcF >500 (msec)	0 Percentage of Participants
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) % participants with any baseline increase	98.7 Percentage of Participants
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) % participants baseline increase <30 (msec)	79.2 Percentage of Participants
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) % participants baseline increase ≥30 to <60 (msec)	18.2 Percentage of Participants
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) % participants baseline increase ≥60 (msec)	1.3 Percentage of Participants

Adverse Events

Inotuzumab Ozogamicin - NHL Type (Follicular)

Serious events: 12 serious events

Other events: 69 other events

Deaths: 0 deaths

Inotuzumab Ozogamicin - NHL Type (Marginal Zone)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Inotuzumab Ozogamicin - NHL Type (Follicular) n=72 participants at risk Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Marginal Zone) n=4 participants at risk Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic) n=5 participants at risk Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ascites	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal obstruction	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Catheter site infection	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Peritonitis	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Staphylococcal bacteraemia	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Hydronephrosis	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary retention	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Budd-Chiari syndrome	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholelithiasis	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic function abnormal	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Inotuzumab Ozogamicin - NHL Type (Follicular) n=72 participants at risk Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Marginal Zone) n=4 participants at risk Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic) n=5 participants at risk Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m\^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Metabolism and nutrition disorders Hypophosphataemia	12.5% 9/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	16.7% 12/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	36.1% 26/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	50.0% 2/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphopenia	34.7% 25/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	50.0% 2/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	55.6% 40/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	80.0% 4/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	76.4% 55/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	75.0% 3/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	40.0% 2/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 9/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	5.6% 4/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Eye disorders Visual impairment	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	8.3% 6/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	11.1% 8/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain lower	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	8.3% 6/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	16.7% 12/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	11.1% 8/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.2% 3/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	48.6% 35/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	50.0% 2/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophagitis	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	5.6% 4/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	19.4% 14/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Chills	8.3% 6/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Early satiety	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	47.2% 34/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	75.0% 3/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	40.0% 2/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	9.7% 7/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	19.4% 14/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Genital infection fungal	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	11.1% 8/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral candidiasis	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	6.9% 5/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	12.5% 9/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	6.9% 5/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	22.2% 16/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	44.4% 32/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	50.0% 2/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase increased	29.2% 21/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Blood chloride increased	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	6.9% 5/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Blood lactate dehydrogenase increased	6.9% 5/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Blood magnesium decreased	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Blood potassium decreased	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Blood urea increased	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Gamma-glutamyltransferase increased	29.2% 21/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Lymphocyte count increased	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Monocyte count increased	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Investigations Protein urine present	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	40.0% 2/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	5.6% 4/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	15.3% 11/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	27.8% 20/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	50.0% 2/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	12.5% 9/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperuricaemia	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	13.9% 10/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypocalcaemia	6.9% 5/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	2.8% 2/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	11.1% 8/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypomagnesaemia	5.6% 4/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	5.6% 4/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	5.6% 4/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	6.9% 5/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	16.7% 12/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Delirium	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	11.1% 8/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 12/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.9% 5/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	25.0% 1/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	40.0% 2/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 6/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Productive cough	1.4% 1/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	20.0% 1/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Petechiae	5.6% 4/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	12.5% 9/72 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/4 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/5 • Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60