Trial Outcomes & Findings for A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma (NCT NCT04074330)
NCT ID: NCT04074330
Last Updated: 2024-06-14
Results Overview
Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Results posted on
2024-06-14
Participant Flow
Participants took part in the study at 12 investigative sites in the United States, Canada, and Japan from 15 October 2019 to 26 April 2023.
Participants with a diagnosis of Non-Hodgkin Lymphoma were enrolled in this study consisting of Phase 1 (Dose Escalation and Japan-Specific lead-in cohorts), and Phase 2 (Dose Expansion) to receive TAK-981 and/or rituximab.
Participant milestones
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (A): TAK-981 120 mg
Participants with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (C): TAK-981 120 mg
Participants with follicular lymphoma (FL) received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
Participants with indolent or aggressive non-Hodgkin lymphoma (NHL) received TAK-981 10 mg, infusion, intravenously (IV), once weekly (QW) on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 milligram per square meter (mg/m\^2), infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or disease progression (PD) or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation (up to 19.36 Months)
STARTED
|
8
|
6
|
1
|
3
|
0
|
0
|
3
|
4
|
3
|
7
|
|
Dose Escalation (up to 19.36 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation (up to 19.36 Months)
NOT COMPLETED
|
8
|
6
|
1
|
3
|
0
|
0
|
3
|
4
|
3
|
7
|
|
Dose Expansion (up to 42 Months)
STARTED
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Dose Expansion (up to 42 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion (up to 42 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (A): TAK-981 120 mg
Participants with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (C): TAK-981 120 mg
Participants with follicular lymphoma (FL) received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
Participants with indolent or aggressive non-Hodgkin lymphoma (NHL) received TAK-981 10 mg, infusion, intravenously (IV), once weekly (QW) on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 milligram per square meter (mg/m\^2), infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or disease progression (PD) or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation (up to 19.36 Months)
Death
|
4
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Dose Escalation (up to 19.36 Months)
Progressive Disease
|
2
|
2
|
1
|
2
|
0
|
0
|
2
|
0
|
0
|
5
|
|
Dose Escalation (up to 19.36 Months)
Start of New Systemic Treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Dose Escalation (up to 19.36 Months)
Site Terminated by Sponsor
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation (up to 19.36 Months)
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Dose Escalation (up to 19.36 Months)
Reason not Specified
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Dose Expansion (up to 42 Months)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion (up to 42 Months)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg BIW
n=8 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (A): TAK-981 120 mg
n=2 Participants
Participants with r/r DLBCL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (C): TAK-981 120 mg
n=1 Participants
Participants with FL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
n=5 Participants
|
69.3 years
n=7 Participants
|
73.0 years
n=5 Participants
|
57.7 years
n=4 Participants
|
64.8 years
n=21 Participants
|
58.8 years
n=10 Participants
|
61.0 years
n=115 Participants
|
70.3 years
n=24 Participants
|
71 years
n=42 Participants
|
55 years
n=42 Participants
|
64.5 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)Population: Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=8 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)
|
8 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)Population: Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which was assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=8 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Grade 3 or Higher TEAEs
|
7 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)Population: Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=8 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of TEAEs
|
11.0 days
Interval 1.0 to 274.0
|
10.0 days
Interval 1.0 to 838.0
|
2.0 days
Interval 1.0 to 657.0
|
—
|
57.0 days
Interval 1.0 to 775.0
|
8.0 days
Interval 1.0 to 575.0
|
13.0 days
Interval 1.0 to 473.0
|
2.0 days
Interval 1.0 to 360.0
|
PRIMARY outcome
Timeframe: Up to 42 monthsPopulation: The DLT-evaluable analysis set will include participants enrolled in the Phase 1 portion of the study who experienced a DLT at any time after initiation of the first infusion of TAK-981 or who completed all planned infusions of TAK-981 as per schedule plus 3 infusions of rituximab without experiencing a DLT. Overall number of participants analyzed is the number of participants available for analysis.
DLTs were evaluated according to NCI CTCAE, Version 5.0.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) Per Dose Level
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens.
ORR was defined as the percentage of participants who achieved complete response (CR) and partial response (PR), as defined by the investigator according to Lugano classification for lymphomas during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR)
|
—
|
—
|
—
|
—
|
50 percentage of participants
|
100 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)Population: Pharmacokinetic (PK) analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled. This outcome measure was planned to be analyzed for Phase 1 only.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-981
Cycle 1 Day 1
|
810 nanograms per millilitre (ng/ml)
Standard Deviation 305
|
740 nanograms per millilitre (ng/ml)
Standard Deviation 491
|
833 nanograms per millilitre (ng/ml)
Standard Deviation 73.3
|
—
|
39.8 nanograms per millilitre (ng/ml)
Standard Deviation 19.1
|
184 nanograms per millilitre (ng/ml)
Standard Deviation 139
|
444 nanograms per millilitre (ng/ml)
Standard Deviation 323
|
648 nanograms per millilitre (ng/ml)
Standard Deviation 214
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-981
Cycle 1 Day 8
|
967 nanograms per millilitre (ng/ml)
Standard Deviation 299
|
981 nanograms per millilitre (ng/ml)
Standard Deviation 272
|
731 nanograms per millilitre (ng/ml)
Standard Deviation 346
|
—
|
51.4 nanograms per millilitre (ng/ml)
Standard Deviation 13.9
|
200 nanograms per millilitre (ng/ml)
Standard Deviation 152
|
595 nanograms per millilitre (ng/ml)
Standard Deviation 410
|
600 nanograms per millilitre (ng/ml)
Standard Deviation 146
|
SECONDARY outcome
Timeframe: Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)Population: PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled. This outcome measure was planned to be analyzed for Phase 1 only.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax: Time of First Occurrence of the Maximum Plasma Concentration (Cmax) for TAK-981
Cycle 1 Day 8
|
1.05 hours
Interval 1.0 to 1.3
|
1.11 hours
Interval 1.05 to 1.19
|
1.12 hours
Interval 1.04 to 1.67
|
—
|
1.15 hours
Interval 1.07 to 1.24
|
1.08 hours
Interval 1.04 to 1.27
|
0.95 hours
Interval 0.93 to 1.02
|
1.08 hours
Interval 1.02 to 1.72
|
|
Tmax: Time of First Occurrence of the Maximum Plasma Concentration (Cmax) for TAK-981
Cycle 1 Day 1
|
1.17 hours
Interval 1.07 to 1.53
|
1.28 hours
Interval 1.1 to 1.95
|
1.12 hours
Interval 1.12 to 1.48
|
—
|
1.17 hours
Interval 1.15 to 1.2
|
1.15 hours
Interval 1.14 to 1.42
|
1.14 hours
Interval 0.97 to 1.29
|
1.14 hours
Interval 1.09 to 1.39
|
SECONDARY outcome
Timeframe: Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)Population: PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled. This outcome measure was planned to be analyzed for Phase 1 only.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981
Cycle 1 Day 1
|
1490 hours*ng/mL
Standard Deviation 475
|
1640 hours*ng/mL
Standard Deviation 484
|
1520 hours*ng/mL
Standard Deviation 103
|
—
|
146 hours*ng/mL
Standard Deviation 15.0
|
477 hours*ng/mL
Standard Deviation 130
|
1070 hours*ng/mL
Standard Deviation 456
|
1310 hours*ng/mL
Standard Deviation 380
|
|
AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981
Cycle 1 Day 8
|
1640 hours*ng/mL
Standard Deviation 483
|
1780 hours*ng/mL
Standard Deviation 333
|
1420 hours*ng/mL
Standard Deviation 356
|
—
|
140 hours*ng/mL
Standard Deviation 25.6
|
517 hours*ng/mL
Standard Deviation 236
|
1160 hours*ng/mL
Standard Deviation 510
|
1290 hours*ng/mL
Standard Deviation 351
|
SECONDARY outcome
Timeframe: Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)Population: PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled. This outcome measure was planned to be analyzed for Phase 1 only.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981
Cycle 1 Day 1
|
1640 h.ng/ml
Standard Deviation 445
|
1600 h.ng/ml
Standard Deviation 550
|
1560 h.ng/ml
Standard Deviation 114
|
—
|
151 h.ng/ml
Standard Deviation 15.1
|
498 h.ng/ml
Standard Deviation 128
|
1110 h.ng/ml
Standard Deviation 465
|
1360 h.ng/ml
Standard Deviation 398
|
|
AUC0-∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981
Cycle 1 Day 8
|
1780 h.ng/ml
Standard Deviation 490
|
1830 h.ng/ml
Standard Deviation 344
|
1460 h.ng/ml
Standard Deviation 382
|
—
|
150 h.ng/ml
Standard Deviation 19.2
|
538 h.ng/ml
Standard Deviation 242
|
1210 h.ng/ml
Standard Deviation 514
|
1330 h.ng/ml
Standard Deviation 359
|
SECONDARY outcome
Timeframe: Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)Population: PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled. This outcome measure was planned to be analyzed for Phase 1 only.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
t1/2z: Terminal Disposition Phase Half-life for TAK-981
Cycle 1 Day 8
|
5.59 hours
Interval 3.1 to 10.93
|
5.73 hours
Interval 5.23 to 6.46
|
5.45 hours
Interval 4.16 to 6.91
|
—
|
5.03 hours
Interval 3.15 to 5.92
|
5.92 hours
Interval 5.51 to 6.15
|
5.77 hours
Interval 5.12 to 7.14
|
5.78 hours
Interval 4.98 to 6.29
|
|
t1/2z: Terminal Disposition Phase Half-life for TAK-981
Cycle 1 Day 1
|
4.88 hours
Interval 4.21 to 7.23
|
5.78 hours
Interval 2.87 to 8.35
|
5.91 hours
Interval 5.12 to 6.0
|
—
|
5.06 hours
Interval 4.78 to 5.41
|
5.88 hours
Interval 5.31 to 6.76
|
6.02 hours
Interval 5.67 to 6.46
|
5.75 hours
Interval 4.5 to 7.01
|
SECONDARY outcome
Timeframe: Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)Population: PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled. This outcome measure was planned to be analyzed for Phase 1 only.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
CL: Total Clearance After Intravenous Administration for TAK-981
Cycle 1 Day 1
|
58.2 litres per hour (L/h)
Standard Deviation 15.5
|
81.8 litres per hour (L/h)
Standard Deviation 24.7
|
38.6 litres per hour (L/h)
Standard Deviation 2.78
|
—
|
66.8 litres per hour (L/h)
Standard Deviation 6.37
|
83.8 litres per hour (L/h)
Standard Deviation 17.8
|
65.2 litres per hour (L/h)
Standard Deviation 37.0
|
72.7 litres per hour (L/h)
Standard Deviation 27.2
|
|
CL: Total Clearance After Intravenous Administration for TAK-981
Cycle 1 Day 8
|
53.9 litres per hour (L/h)
Standard Deviation 14.6
|
68.0 litres per hour (L/h)
Standard Deviation 16.1
|
43.2 litres per hour (L/h)
Standard Deviation 13.1
|
—
|
67.4 litres per hour (L/h)
Standard Deviation 8.23
|
75.2 litres per hour (L/h)
Standard Deviation 43.8
|
57.8 litres per hour (L/h)
Standard Deviation 26.2
|
73.3 litres per hour (L/h)
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: Cycle 1: Days 1 and 8, pre-infusion and at multiple timepoints (Up to 24 hours) post end of infusion (cycle length=21 days)Population: PK analysis set consisted of participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.
As per planned analysis, data for this outcome measure were collected and analyzed for the combined population (Phase 1: TAK-981 60mg QW+Japan Lead-in: TAK-981 60mg QW) based on regimen in which same dose groups in Phase 1 irrespective of nationality were pooled. This outcome measure was planned to be analyzed for Phase 1 only.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-981
Cycle 1 Day 1
|
255 litres (L)
Standard Deviation 75.5
|
410 litres (L)
Standard Deviation 156
|
154 litres (L)
Standard Deviation 1.72
|
—
|
396 litres (L)
Standard Deviation 72.8
|
517 litres (L)
Standard Deviation 202
|
406 litres (L)
Standard Deviation 277
|
352 litres (L)
Standard Deviation 136
|
|
Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-981
Cycle 1 Day 8
|
273 litres (L)
Standard Deviation 201
|
307 litres (L)
Standard Deviation 95.0
|
189 litres (L)
Standard Deviation 68.0
|
—
|
352 litres (L)
Standard Deviation 79.9
|
456 litres (L)
Standard Deviation 278
|
332 litres (L)
Standard Deviation 211
|
347 litres (L)
Standard Deviation 110
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens.
ORR is defined as the percentage of participants who achieved CR and PR, as defined by the investigator according to Lugano classification for lymphomas during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Overall Response Rate (ORR)
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
66.7 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens.
DCR is defined as the percentage of participants who achieved CR, PR, and stable disease (SD) as defined by the investigator according to Lugano classification for Lymphomas during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR)
|
16.7 percenage of participants
|
50.0 percenage of participants
|
0 percenage of participants
|
33.3 percenage of participants
|
100 percenage of participants
|
50.0 percenage of participants
|
100 percenage of participants
|
28.6 percenage of participants
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens. Overall number of participants analyzed is the number of participants with events.
DOR is the time from the date of first documentation of a PR or better to the date of first documentation of PD for responders (PR or better). DOR was assessed by the investigator according to Lugano classification for lymphoma during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Response (DOR)
|
—
|
—
|
—
|
8.94 months
Interval 8.94 to 8.94
|
8.31 months
Interval 8.31 to 8.31
|
—
|
—
|
2.73 months
Interval 2.73 to 2.73
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens. Overall number of participants analyzed is the number of participants with events.
TTP is defined as the time from the date of first study drug administration to the date of first documented disease progression. TTP was assessed by the investigator according to Lugano classification for lymphoma during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=5 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Progression (TTP)
|
1.48 months
Interval 0.0 to 3.91
|
NA months
Interval 0.92 to 19.09
Median was not estimable as there were censored participants with events.
|
—
|
13.18 months
Interval 13.18 to 13.18
|
12.42 months
Interval 2.69 to 12.42
|
—
|
—
|
1.58 months
Interval 0.95 to 3.98
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens. Overall number of participants analyzed are the number of participants with events.
PFS is defined as the time from the date of the first dose administration to the date of first documentation of PD or death due to any cause, whichever occurs first. PD was determined by Response Evaluation Criteria in Lymphoma. PFS was assessed by the investigator according to Lugano classification for lymphoma during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=5 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Progression-Free Survival (PFS)
|
2.33 months
Interval 0.43 to 3.91
|
NA months
Interval 1.61 to 19.09
Median was not estimable as there were censored participants with events.
|
—
|
13.18 months
Interval 13.18 to 13.18
|
12.42 months
Interval 2.69 to 12.42
|
—
|
—
|
1.58 months
Interval 1.25 to 3.98
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (1 hour, 4 hours, 8 hours) and Day 8 (Pre-dose, 1 hour, 4 hours and 8 hours) (Cycle length = 21 days)Population: Pharmacodynamic analysis set consisted of participants who have provided evaluable blood samples (C1D1 predose sample and at least 1 postdose sample). Number of participants available is the number of participants with data available for analysis at the specified time point.
The level of TAK-981-SUMO adduct formation was evaluated as the percentage of adduct formed in blood. Positive change denotes improvement.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=5 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=5 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 1 /1 Hour Postdose
|
7.6 ratio
Standard Deviation 0.73
|
9.9 ratio
Standard Deviation 2.84
|
4.9 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
6.7 ratio
Standard Deviation 1.42
|
4.1 ratio
Standard Deviation 0.54
|
5.7 ratio
Standard Deviation 1.47
|
6.3 ratio
Standard Deviation 1.02
|
9.5 ratio
Standard Deviation 1.04
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 1 /4 Hours Postdose
|
4.9 ratio
Standard Deviation 1.69
|
6.5 ratio
Standard Deviation 0.56
|
—
|
4.1 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
3.6 ratio
Standard Deviation 0.66
|
4.7 ratio
Standard Deviation 1.18
|
4.7 ratio
Standard Deviation 1.28
|
6.7 ratio
Standard Deviation 1.07
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 1 /8 Hours Postdose
|
4.6 ratio
Standard Deviation 0.72
|
5.2 ratio
Standard Deviation 0.64
|
3.0 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
3.3 ratio
Standard Deviation 0.32
|
3.7 ratio
Standard Deviation 0.27
|
4.5 ratio
Standard Deviation 1.22
|
4.1 ratio
Standard Deviation 1.24
|
5.6 ratio
Standard Deviation 1.05
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 8 /Predose
|
2.8 ratio
Standard Deviation 0.51
|
2.8 ratio
Standard Deviation 1.50
|
1.1 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
1.6 ratio
Standard Deviation 0.17
|
1.8 ratio
Standard Deviation 0.13
|
1.9 ratio
Standard Deviation 0.68
|
1.9 ratio
Standard Deviation 0.27
|
2.5 ratio
Standard Deviation 0.88
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 8 /1 Hour Postdose
|
7.8 ratio
Standard Deviation 0.61
|
11.6 ratio
Standard Deviation 6.34
|
5.0 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
5.4 ratio
Standard Deviation 0.69
|
4.6 ratio
Standard Deviation 0.19
|
6.6 ratio
Standard Deviation 0.96
|
8.0 ratio
Standard Deviation 0.87
|
9.1 ratio
Standard Deviation 3.21
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 8 /4 Hours Postdose
|
5.8 ratio
Standard Deviation 0.65
|
5.6 ratio
Standard Deviation 1.73
|
—
|
4.3 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
3.9 ratio
Standard Deviation 0.19
|
6.2 ratio
Standard Deviation 1.87
|
5.1 ratio
Standard Deviation 0.70
|
6.1 ratio
Standard Deviation 2.16
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 8 /8 Hours Postdose
|
4.0 ratio
Standard Deviation 1.43
|
7.1 ratio
Standard Deviation 2.83
|
2.9 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
3.3 ratio
Standard Deviation 0.38
|
3.2 ratio
Standard Deviation 0.55
|
4.2 ratio
Standard Deviation 1.34
|
4.0 ratio
Standard Deviation 0.49
|
5.3 ratio
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 8 (Cycle length = 21 days)Population: Pharmacodynamic analysis set consisted of participants who have provided evaluable skin biopsies (screening sample and postdose sample). Overall number of participants available is the number of participants available for analysis. Number of participants available is the number of participants with data available for analysis at the specified time point.
The level of TAK-981-SUMO adduct formation was evaluated as the percentage of adduct formed in skin.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Skin as Assessed by Immunohistochemistry (IHC) During Phase 1
Cycle 1 Day 1 /Predose
|
—
|
0.0 % adduct positive
Standard Deviation 0.0
|
0.0 % adduct positive
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
0.0 % adduct positive
Standard Deviation 0.0
|
0.0 % adduct positive
Standard Deviation 0.03
|
0.0 % adduct positive
Standard Deviation 0.0
|
0.0 % adduct positive
Standard Deviation 0.0
|
0.0 % adduct positive
Standard Deviation 0.0
|
|
Phase 1: Levels of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Skin as Assessed by Immunohistochemistry (IHC) During Phase 1
Cycle 1 Day 8
|
59.7 % adduct positive
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
11.2 % adduct positive
Standard Deviation 11.35
|
1.4 % adduct positive
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
29.5 % adduct positive
Standard Deviation 19.88
|
1.2 % adduct positive
Standard Deviation 1.15
|
15.8 % adduct positive
Standard Deviation 12.70
|
27.0 % adduct positive
Standard Deviation 12.29
|
22.6 % adduct positive
Standard Deviation 9.47
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (1 hour, 4 hours, 8 hours) and Day 8 (Pre-dose, 1 hour, 4 hours and 8 hours) (Cycle length = 21 days)Population: Pharmacodynamic analysis set consisted of participants who have provided evaluable blood samples (C1D1 predose sample and at least 1 postdose sample). Overall number of participants analyzed are the number of participants available for analysis. Number of participants available is the number of participants with data available for analysis at the specified time point.
SUMO pathway inhibition in blood was evaluated by flow cytometry with an antibody recognizing SUMO2/3 chains.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=5 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=5 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=7 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 1 /4 Hours Postdose
|
0.4 ratio
Standard Deviation 0.30
|
0.9 ratio
Standard Deviation 0.14
|
—
|
1.0 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
0.9 ratio
Standard Deviation 0.07
|
0.8 ratio
Standard Deviation 0.15
|
0.5 ratio
Standard Deviation 0.34
|
0.5 ratio
Standard Deviation 0.15
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 8 /4 Hours Postdose
|
0.7 ratio
Standard Deviation 0.05
|
0.7 ratio
Standard Deviation 0.10
|
—
|
1.2 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
0.9 ratio
Standard Deviation 0.09
|
0.7 ratio
Standard Deviation 0.31
|
0.5 ratio
Standard Deviation 0.23
|
0.6 ratio
Standard Deviation 0.20
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 1 /1 Hour Postdose
|
0.5 ratio
Standard Deviation 0.26
|
0.6 ratio
Standard Deviation 0.22
|
0.1 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
0.8 ratio
Standard Deviation 0.33
|
0.9 ratio
Standard Deviation 0.05
|
0.8 ratio
Standard Deviation 0.15
|
0.5 ratio
Standard Deviation 0.36
|
0.6 ratio
Standard Deviation 0.11
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 1 /8 Hours Postdose
|
0.5 ratio
Standard Deviation 0.22
|
0.7 ratio
Standard Deviation 0.28
|
0.2 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
0.8 ratio
Standard Deviation 0.24
|
1.0 ratio
Standard Deviation 0.05
|
0.8 ratio
Standard Deviation 0.17
|
0.5 ratio
Standard Deviation 0.33
|
0.5 ratio
Standard Deviation 0.15
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 8 /Predose
|
0.9 ratio
Standard Deviation 0.07
|
1.1 ratio
Standard Deviation 0.25
|
0.2 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
0.7 ratio
Standard Deviation 0.33
|
0.9 ratio
Standard Deviation 0.09
|
1.1 ratio
Standard Deviation 0.37
|
0.8 ratio
Standard Deviation 0.12
|
1.1 ratio
Standard Deviation 0.46
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 8 /1 Hour Postdose
|
0.5 ratio
Standard Deviation 0.14
|
0.6 ratio
Standard Deviation 0.10
|
0.1 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
0.5 ratio
Standard Deviation 0.25
|
0.9 ratio
Standard Deviation 0.10
|
0.8 ratio
Standard Deviation 0.34
|
0.5 ratio
Standard Deviation 0.19
|
0.5 ratio
Standard Deviation 0.05
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood as Assessed by Flow Cytometry During Phase 1
Cycle 1 Day 8 /8 Hours Postdose
|
0.5 ratio
Standard Deviation 0.35
|
0.7 ratio
Standard Deviation 0.17
|
0.2 ratio
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
0.7 ratio
Standard Deviation 0.31
|
0.9 ratio
Standard Deviation 0.09
|
0.7 ratio
Standard Deviation 0.37
|
0.5 ratio
Standard Deviation 0.04
|
0.5 ratio
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 8 (Cycle length = 21 days)Population: Pharmacodynamic analysis set consisted of participants who have provided evaluable skin biopsies (screening sample and postdose sample). Overall number of participants available is the number of participants available for analysis. Number of participants available is the number of participants with data available for analysis at the specified time point.
SUMO pathway inhibition in skin was evaluated with skin tissue biopsies by IHC.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
n=1 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
n=3 Participants
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=4 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
n=3 Participants
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
n=6 Participants
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1: SUMO Pathway Inhibition in Skin as Assessed by Immunohistochemistry (IHC) During Phase 1
Cycle 1 Day 8
|
51.84200 % Sumo 2/3 positive
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
63.14625 % Sumo 2/3 positive
Standard Deviation 15.415286
|
69.68880 % Sumo 2/3 positive
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
41.79763 % Sumo 2/3 positive
Standard Deviation 21.796849
|
82.26130 % Sumo 2/3 positive
Standard Deviation 2.017705
|
79.34405 % Sumo 2/3 positive
Standard Deviation 10.262143
|
55.69903 % Sumo 2/3 positive
Standard Deviation 19.325964
|
52.54200 % Sumo 2/3 positive
Standard Deviation 15.606775
|
|
Phase 1: SUMO Pathway Inhibition in Skin as Assessed by Immunohistochemistry (IHC) During Phase 1
Cycle 1 Day 1 /Predose
|
—
|
75.79235 % Sumo 2/3 positive
Standard Deviation 2.586486
|
86.85370 % Sumo 2/3 positive
Standard Deviation NA
Standard deviation was not estimable as there was only one participant.
|
69.65077 % Sumo 2/3 positive
Standard Deviation 19.035919
|
83.40383 % Sumo 2/3 positive
Standard Deviation 2.692876
|
87.74383 % Sumo 2/3 positive
Standard Deviation 5.142812
|
89.60727 % Sumo 2/3 positive
Standard Deviation 5.528530
|
89.63755 % Sumo 2/3 positive
Standard Deviation 4.044536
|
SECONDARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)Population: Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)
|
—
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)Population: Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which was assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Grade 3 or Higher TEAEs
|
—
|
—
|
—
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)Population: Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of TEAEs
|
—
|
—
|
—
|
—
|
8.0 days
Interval 1.0 to 483.0
|
2.0 days
Interval 1.0 to 349.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens.
CR is defined as the percentage of participants who achieved CR, PR, and SD as defined by the investigator according to Lugano classification for Lymphomas during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Disease Control Rate (DCR)
|
—
|
—
|
—
|
—
|
1 percentage of participants
|
1 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens.
DOR is the time from the date of first documentation of a PR or better to the date of first documentation of PD for responders (PR or better). DOR was assessed by the investigator according to Lugano classification for lymphoma during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR)
|
—
|
—
|
—
|
—
|
3.32 months
Interval 3.32 to 3.32
|
0.03 months
Interval 0.03 to 0.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens.
TTP is defined as the time from the date of first study drug administration to the date of first documented disease progression. TTP was assessed by the investigator according to Lugano classification for lymphoma during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Progression (TTP)
|
—
|
—
|
—
|
—
|
5.32 months
Interval 5.32 to 5.32
|
1.48 months
Interval 1.48 to 1.48
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 monthsPopulation: Response-evaluable analysis set consisted of participants who have received at least 1 dose of study drug, have sites of measurable disease at Baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happens.
PFS is defined as the time from the date of the first dose administration to the date of first documentation of PD or death due to any cause, whichever occurs first. PD was determined by Response Evaluation Criteria in Lymphoma. PFS was assessed by the investigator according to Lugano classification for lymphoma during the study.
Outcome measures
| Measure |
Phase 1: TAK-981 90mg BIW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 120mg QW
Participants with indolent or aggressive NHL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg QW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK-981 60mg BIW
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 10mg QW
n=2 Participants
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 40mg QW
n=1 Participants
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 60mg QW
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK-981 90mg QW
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2: Progression-Free Survival (PFS)
|
—
|
—
|
—
|
—
|
3.15 months
Interval 1.0 to 5.3
|
1.48 months
Interval 1.48 to 1.48
|
—
|
—
|
Adverse Events
Phase 1: TAK981 10mg QW
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: TAK981 40mg QW
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1: TAK981 60mg QW
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: TAK981 90mg QW
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1: TAK981 90mg BIW
Serious events: 5 serious events
Other events: 8 other events
Deaths: 4 deaths
Phase 1: TAK981 120mg QW
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Japan Lead-in: TAK981 60mg QW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Japan Lead-in: TAK981 60mg BIW
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2 (A): TAK981 120mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 2 (C): TAK981 120mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: TAK981 10mg QW
n=3 participants at risk
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 40mg QW
n=4 participants at risk
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 60mg QW
n=3 participants at risk
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 90mg QW
n=7 participants at risk
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 90mg BIW
n=8 participants at risk
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 120mg QW
n=6 participants at risk
Participants with indolent or aggressive NHL TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK981 60mg QW
n=1 participants at risk
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK981 60mg BIW
n=3 participants at risk
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (A): TAK981 120mg
n=2 participants at risk
Participants with r/r DLBCL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (C): TAK981 120mg
n=1 participants at risk
Participants with FL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Death
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
Other adverse events
| Measure |
Phase 1: TAK981 10mg QW
n=3 participants at risk
Participants with indolent or aggressive NHL received TAK-981 10 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 40mg QW
n=4 participants at risk
Participants with indolent or aggressive NHL received TAK-981 40 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 60mg QW
n=3 participants at risk
Participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 90mg QW
n=7 participants at risk
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 90mg BIW
n=8 participants at risk
Participants with indolent or aggressive NHL received TAK-981 90 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 1: TAK981 120mg QW
n=6 participants at risk
Participants with indolent or aggressive NHL TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK981 60mg QW
n=1 participants at risk
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab 375 mg/m\^2, infusion, IV, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Japan Lead-in: TAK981 60mg BIW
n=3 participants at risk
Japanese participants with indolent or aggressive NHL received TAK-981 60 mg, infusion, IV, BIW on Days 1, 4, 8, and 11 every 21 days in each 21-day treatment cycle for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (A): TAK981 120mg
n=2 participants at risk
Participants with r/r DLBCL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
Phase 2 (C): TAK981 120mg
n=1 participants at risk
Participants with FL received TAK-981 120 mg, infusion, IV, QW on Days 1 and 8 every 21 days in each 21-day treatment cycle in combination with rituximab infusion, intravenously, once on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of each 21-day treatment cycle from Cycle 2 for up to 12 months or PD or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Paraesthesia
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
71.4%
5/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
37.5%
3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
83.3%
5/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
2/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
QRS axis abnormal
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
3/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
2/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
28.6%
2/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
2/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
28.6%
2/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
37.5%
3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
3/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
2/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
Campylobacter colitis
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Catheter site swelling
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Chills
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
42.9%
3/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
37.5%
3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
83.3%
5/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
2/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
37.5%
3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
2/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
2/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
28.6%
2/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
2/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
2/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
2/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
2/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Electrocardiogram P wave abnormal
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Eye disorders
Eye oedema
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Facial pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Fatigue
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
83.3%
5/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
28.6%
2/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
4/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
3/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
2/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Infusion site pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Infusion site reaction
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
37.5%
3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
12.5%
1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
66.7%
2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
28.6%
2/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
4/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
50.0%
1/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
100.0%
1/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
25.0%
1/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
28.6%
2/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
14.3%
1/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
33.3%
1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/4 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/7 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
16.7%
1/6 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/2 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
0.00%
0/1 • From the first dose of study drug through 30 days after the last dose of study drug (up to 42 months)
Safety Analysis Set consisted of participants who have received at least 1 dose, even if incomplete, of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER